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2026-08-20 12:28 20d ago
2026-08-20 07:00 20d ago
IHEEZO snížilo pacienty hlášené nepohodlí po injekcích o 58 %
HROW Harrow Health
FMP Stock News 72
Original source text
NASHVILLE, Tenn., Aug. 20, 2026 (GLOBE NEWSWIRE) -- Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, today announced positive results from a prospective, randomized, contralateral-eye study evaluating IHEEZO® (chloroprocaine hydrochloride ophthalmic gel) 3%, an ophthalmic gel indicated for ocular surface anesthesia, in patients undergoing same-day bilateral intravitreal injections. The single-center, investigator-initiated study demonstrated statistically significant differences favoring IHEEZO at every measured time point.

Patients reported approximately 58% less discomfort overall in the IHEEZO-treated eye than in the fellow eye treated with proparacaine ophthalmic solution 0.5%, a statistically significant difference at all four post-injection assessments (all p≤0.048). The largest absolute treatment differences were observed immediately after injection, when discomfort is highest: 1.44 versus 3.06 at two minutes and 1.26 versus 2.82 at one hour, while lower discomfort scores with IHEEZO remained evident through the 24-hour assessment.

Millionsi of intravitreal injections are performed in the United States each year — making them among the most frequently performed procedures in ophthalmology — and they are often administered repeatedly over months or years to patients with retinal diseases. As a result, the injection experience, including patient discomfort, can become an important consideration for both patients and retina specialists, particularly in practices managing a high volume of patients who return regularly for treatment.

Study Results

IHEEZO was associated with lower patient-reported discomfort at all four post-injection assessments, measured using a standard 0-to-10 numeric rating scale:

The results showed a consistent benefit with IHEEZO throughout the 24-hour assessment period, with lower patient-reported discomfort at every time point. The largest absolute differences occurred shortly after injection, when discomfort is highest. Absolute treatment differences were 1.62 points at two minutes and 1.56 points at one hour, and lower discomfort scores with IHEEZO remained evident through the 24-hour assessment.

“Patient comfort is a larger part of the intravitreal injection experience than it is sometimes given credit for,” said Travis Peck, MD, Retina Consultants of Delmarva, principal investigator of the study. “Because each patient received both anesthetic approaches on the same day, we were able to directly compare the patient experience. Patients consistently reported less discomfort in the IHEEZO-treated eye across all time points we measured. For retina specialists who perform a high volume of injections and care for patients who return repeatedly for treatment, these are practical and clinically relevant findings.”

“These results provide new clinical evidence from a real-world practice setting supporting IHEEZO’s differentiated clinical profile versus commonly administered legacy ophthalmic anesthesia modalities – demonstrating a measurable improvement in patient-reported comfort following intravitreal injections,” said Mark L. Baum, Chief Executive Officer of Harrow. “Retina specialists work to preserve vision in patients who require ongoing treatment over many years, and the experience of each of those visits matters and ideally, should be optimized. The consistency and magnitude of the reduction in patient discomfort should strengthen physician confidence in IHEEZO’s clinical profile and support broader utilization of the product across retina practices.”

About the Study

The investigator-initiated study was a prospective, randomized, contralateral-eye comparison conducted in a private retina practice. The study evaluated 100 eyes from 50 adult patients undergoing same-day bilateral intravitreal injections. Both eyes received 2% lidocaine-soaked pledgets prior to administration of the randomized study anesthetic. In each patient, one randomly assigned eye received IHEEZO prior to injection and the fellow eye received preservative-containing proparacaine ophthalmic solution 0.5%, allowing each patient to serve as his or her own control and reducing between-patient variability.

Patient-reported ocular discomfort was assessed using a 0-to-10 numeric rating scale at 2 minutes, 1 hour, 6–12 hours, and 24 hours following injection.

IHEEZO® (chloroprocaine hydrochloride ophthalmic gel) 3%, for topical ophthalmic use

INDICATIONS AND USAGE

IHEEZO is an ester anesthetic indicated for ocular surface anesthesia.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

IHEEZO is contraindicated in patients with a history of hypersensitivity to any component of this preparation

WARNINGS AND PRECAUTIONS

Not for Injection or Intraocular AdministrationCorneal Injury Due to InsensitivityCorneal OpacificationFor Administration by Healthcare Provider: IHEEZO is not intended for patient self-administration ADVERSE REACTIONS

Most common adverse reaction is mydriasis (approximately 25%)
Please see full Prescribing information 

About Harrow

Harrow, Inc. (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America, offering a comprehensive portfolio of products that address conditions affecting both the front and back of the eye, such as dry eye disease, wet (or neovascular) age-related macular degeneration, cataracts, refractive errors, glaucoma and a range of other ocular surface conditions and diseases of the retina. Harrow was founded with a commitment to deliver safe, effective, accessible, and affordable medications that enhance patient compliance and improve clinical outcomes. For more information about Harrow, please visit harrow.com and connect with us on LinkedIn.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward-looking statements.” Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, risks related to: liquidity or results of operations; our ability to successfully implement our business plan, develop and commercialize our products, product candidates and proprietary formulations in a timely manner or at all, identify and acquire additional products, manage our pharmacy operations, service our debt, obtain financing necessary to operate our business, recruit and retain qualified personnel, manage any growth we may experience and successfully realize the benefits of our previous acquisitions and any other acquisitions and collaborative arrangements we may pursue; competition from pharmaceutical companies, outsourcing facilities and pharmacies; general economic and business conditions, including inflation and supply chain challenges; regulatory and legal risks and uncertainties related to our pharmacy operations and the pharmacy and pharmaceutical business in general, including the ongoing communications with the U.S. Food and Drug Administration relating to compliance and quality plans at our outsourcing facility in New Jersey; physician interest in and market acceptance of our current and any future formulations and compounding pharmacies generally. These and additional risks and uncertainties are more fully described in Harrow’s filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2025, and other filings with the SEC. Such documents may be read free of charge on the SEC's web site at sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Harrow undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

Contacts:
Mike Biega
Vice President of Investor Relations and Communications
[email protected]
617-913-8890

i Comparative incidence of endophthalmitis after intravitreal dexamethasone implant versus anti-VEGF injections: a retrospective study. International Journal of Retina and Vitreous. 2026

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/0eb365b1-2cee-40b7-880d-fba9189e1d92
2026-08-11 16:12 29d ago
2026-08-11 11:07 29d ago
Harrow zvýšil tržby a potvrdil celoroční výhled
HROW Harrow Health
FMP Stock News 92
Original source text
Harrow NASDAQ: HROW reported second-quarter revenue of $70.7 million, up 11% from a year earlier and about 60% sequentially, as the ophthalmic pharmaceutical company said it entered the second half of 2026 with stronger demand across several products, improved pricing and expanded commercial infrastructure.

First-half revenue totaled about $115 million, which Chief Executive Officer Mark L. Baum said was below the company’s expectations entering the year, primarily because of the net revenue impact from VEVYE. Harrow nevertheless reiterated its full-year guidance for revenue of $350 million to $365 million and adjusted EBITDA of $80 million to $100 million.

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The outlook implies second-half revenue of roughly $235 million to $250 million. President and Chief Financial Officer Andrew Boll said the company expects sequential revenue growth in both the third and fourth quarters, with the larger increase expected in the fourth quarter.

Second-Quarter Results and Margin Outlook VEVYE generated quarterly revenue of $29.4 million, up nearly 58% year over year. Baum said prescriptions increased 21% sequentially, while the prescriber base expanded 15%. The product ended June with a 14.6% share of the branded dry eye market, according to IQVIA data cited by Chief Commercial Officer Patrick Sullivan.

Harrow changed VEVYE business rules at the end of April, reducing co-pay card utilization and improving the product’s average selling price, according to management. Boll said the company expects additional pricing improvement in the second half as the updated rules apply for a full period, patients meet annual deductibles and expanded commercial coverage takes effect.

IHEEZO generated $15.6 million in second-quarter revenue, largely from wholesaler stocking orders for a new five-pack presentation. Revenue lagged underlying demand because distributors were selling through previously acquired inventory, Boll said. Unit demand reached a quarterly record of 65,477 units, up 44% sequentially and 34% year over year.

Management said IHEEZO channel inventory has normalized, and approximately 25% higher net pricing became effective July 1. Baum said the product’s gross margin exceeds 90% and should make a significant contribution to second-half revenue growth and profitability.

The specialty portfolio and TRIESENCE contributed approximately $11 million of revenue, while the compounded portfolio contributed $14.6 million. TRIESENCE demand rose 162% year over year to 14,529 units, with 54% of demand coming from ocular surgery, Sullivan said.

GAAP gross margin was 71% in the quarter. Harrow expects gross margins to return toward the high-70% range in the second half, supported by IHEEZO’s normalizing revenue cycle, rising revenue, VEVYE growth and product mix.

SG&A expense was $53.3 million, reflecting commercial investments made during the quarter. Excluding employees expected to join through the pending TYRVAYA transaction, Boll said base SG&A is expected to remain approximately flat for the rest of 2026. Adjusted EBITDA was negative $1.2 million, and Harrow ended the quarter with $83.9 million in cash and cash equivalents.

Commercial Expansion and Product Drivers Harrow formally launched BYOOVIZ on July 1, following modest stocking activity during the second quarter. Management said early physician engagement has been encouraging and that the biosimilar product fits within the company’s retinal commercial organization.

The company also cited the relaunch of VERKAZIA, a permanent J-code for IOPIDINE effective July 1, and an expanded Access Plus commercial organization as incremental growth drivers. Harrow tripled its surgical commercial organization during the second quarter to support TRIESENCE, though management said the new representatives remain early in their productivity ramp.

For IHEEZO, Baum said Harrow is concentrating on in-office retina and other procedures following the loss of pass-through reimbursement in cataract surgery on April 1. He said the company estimates it has less than 2% share of its overall addressable IHEEZO market and sees more than 10 million annual procedures across intravitreal injections and other in-office uses as opportunities.

Harrow also secured expanded commercial coverage for VEVYE through a top-three pharmacy benefit manager, effective Aug. 1. Baum said the agreement opens access to “many millions” of commercial lives that had previously been blocked, though he did not disclose formulary positioning. Management said the company expects the coverage agreement to improve unit revenue for VEVYE.

Pending TYRVAYA Acquisition Subject to closing, Harrow plans to acquire global rights to TYRVAYA, a dry eye treatment approved in the U.S. and China and under regulatory review in five additional countries. The company expects to use $30 million of cash on hand for the upfront consideration.

Management expects only a modest TYRVAYA revenue contribution in 2026 due to the anticipated timing of closing and integration. For 2027, Boll said Harrow expects TYRVAYA to generate more than $30 million in revenue and be financially accretive. The company anticipates that adding commercial personnel from Viatris Eye Care will increase annualized SG&A by about $20 million once fully integrated.

Sullivan said TYRVAYA would complement VEVYE by offering a drop-free treatment option, including for contact lens wearers. Harrow expects to integrate experienced dry eye sales representatives from Viatris during the fourth quarter, with the added team supporting both products.

Pipeline Updates Chief Scientific Officer Amir Shojaei said Harrow has secured a pre-new drug application meeting with the U.S. Food and Drug Administration for G-MELT, or MELT-300, scheduled for early in the fourth quarter. The company remains on track to submit a new drug application during the first half of 2027.

G-MELT is being developed as an IV-free, opioid-free procedural sedation option. Assuming a successful regulatory review, Harrow continues to target potential FDA approval in the first half of 2028 and a commercial launch later that year.

Harrow is also advancing YOCHIL, or MELT-210, an orally disintegrating midazolam tablet under development for pediatric patients undergoing diagnostic and therapeutic endoscopic procedures. Shojaei said the company completed an end-of-phase II meeting with the FDA earlier this year and continues to target an NDA submission in 2027.

In addition, Harrow said its QUELL study of IHEEZO is enrolling and is expected to complete enrollment later in 2026, with results anticipated by year-end. The double-masked controlled trial is evaluating anesthetic effect and patient outcomes compared with subconjunctival lidocaine in intravitreal injection procedures.

About Harrow (NASDAQ:HROW)Harrow Health, Inc NASDAQ: HROW is a U.S.-based commercial-stage biopharmaceutical company specializing in ophthalmic therapeutics and diagnostics. The company focuses on the development, manufacturing and distribution of proprietary, generic and branded eye care products designed to treat a range of ocular conditions, including glaucoma, ocular hypertension, dry eye disease and other anterior segment disorders.

Through its wholly owned affiliate ImprimisRx, Harrow Health offers a direct-to-physician model for customized formulations as well as low-cost generic alternatives.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].

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2026-08-11 01:46 29d ago
2026-08-10 21:07 29d ago
Harrow hlásí vyšší ztrátu a nižší tržby za čtvrtletí
HROW Harrow Health
FMP Stock News 78
Original source text
Harrow (HROW - Free Report) came out with a quarterly loss of $0.34 per share versus the Zacks Consensus Estimate of a loss of $0.23. This compares to earnings of $0.24 per share a year ago. These figures are adjusted for non-recurring items.

This quarterly report represents an earnings surprise of -47.83%. A quarter ago, it was expected that this pharmaceutical and drug compounding company would post a loss of $0.43 per share when it actually produced a loss of $0.63, delivering a surprise of -46.51%.

Over the last four quarters, the company has surpassed consensus EPS estimates just once.

Harrow, which belongs to the Zacks Medical - Drugs industry, posted revenues of $70.66 million for the quarter ended June 2026, missing the Zacks Consensus Estimate by 0.61%. This compares to year-ago revenues of $63.74 million. The company has topped consensus revenue estimates just once over the last four quarters.

The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.

Harrow shares have lost about 17.5% since the beginning of the year versus the S&P 500's gain of 13.3%.

What's Next for Harrow?While Harrow has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?

There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.

Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.

Ahead of this earnings release, the estimate revisions trend for Harrow was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.

It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.33 on $100.61 million in revenues for the coming quarter and $0.29 on $350.05 million in revenues for the current fiscal year.

Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Drugs is currently in the top 41% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.

Another stock from the same industry, 60 Degrees Pharmaceuticals Inc. (SXTP - Free Report) , has yet to report results for the quarter ended June 2026.

This company is expected to post quarterly loss of $0.74 per share in its upcoming report, which represents a year-over-year change of +85.2%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.

60 Degrees Pharmaceuticals Inc.'s revenues are expected to be $0.19 million, down 40.3% from the year-ago quarter.
2026-07-20 14:15 1mo ago
2026-07-20 08:00 1mo ago
Samsung Bioepis uvádí srovnatelnou bezpečnost SB11 s ranibizumabem
HROW Harrow Health
FMP Stock News 78
Original source text
July 20, 2026 08:00 ET  | Source: Harrow, Inc.

A real-world PMS study based on a large population demonstrates comparable safety profile of SB11 (BYOOVIZ® / AMELIVU®) to reference ranibizumabIn treatment-naïve patients, SB11 provided functional and anatomical improvements, while BCVA and CST were well maintained in patients who were switched from other anti-VEGF treatments to SB11, adding clinical confidence in using SB11 INCHEON, Korea and NASHVILLE, Tenn., July 20, 2026 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. and Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, presented interim data from a post-marketing surveillance (PMS) study on SB11 (US brand name: BYOOVIZ®, Korea brand name: AMELIVU®), a biosimilar referencing Lucentis1, at the 44th Annual Meeting of the American Society of Retina Specialists (ASRS), held in Montréal, Canada, July 15–18, 2026.

“The interim results from this large-scale post-marketing surveillance study reinforce the comparable safety profile of SB11 to reference ranibizumab. Importantly, the study demonstrated clinically meaningful efficacy improvement in treatment-naïve patients while maintaining efficacy in those switched from other anti-VEGF therapies,” said Donghoon Shin, Executive Vice President and Head of Clinical Sciences Division, Samsung Bioepis. "At Samsung Bioepis, we are committed to generating robust real-world evidence that can support retinal specialists in making informed treatment decisions for their patients."

"We believe this post-marketing surveillance data further strengthens the clinical foundation supporting BYOOVIZ, reinforcing the confidence retina specialists can have in this biosimilar option — both in treatment-naïve patients and those transitioning from other anti-VEGF therapies," said Mark L. Baum, Chief Executive Officer of Harrow. "We're grateful for our collaboration with Samsung Bioepis in generating this evidence, and we remain committed to giving physicians the data they need to prescribe with confidence."

This open-label, prospective, multicenter, observational, Phase 4 PMS study, initiated in May 2022 and completed in May 2026, was designed to evaluate real-world safety and efficacy data for SB11 by evaluating a large patient population from a PMS study conducted in Republic of Korea. The interim report includes data from 298 patients (182 treatment-naïve, 116 switched) out of 305 patients who had been enrolled in the study as of the interim data cutoff. To reflect real-world practice, treatment interval was determined at the investigator’s discretion, and the study followed up with patients up to 24 weeks after the first dose. Efficacy was assessed by best-corrected visual acuity (BCVA) and central subfield thickness (CST), with subgroup analyses by treatment status (naïve/switched). Safety was evaluated by the incidence of adverse events.

The mean (standard deviation; SD) BCVA improved by -0.10 (0.29) in the treatment-naïve patients and -0.03 (0.24) in switched patients (P= 0.0239). Mean (SD) CST improved by -95 (125) µm in the treatment-naïve patients and -53 (108) µm in switched patients (P= 0.0168). Across different indications, there was no statistically significant difference in BCVA (P=0.6312) and CST (P=0.1686) outcome. In contrast, disease duration was significantly associated with BCVA (P= 0.0003) and CST (P=0.001) outcomes, suggesting that earlier treatment may lead to a better visual prognosis. No new safety concerns were identified.

Title: Efficacy and Safety of SB11 in Treatment-Naïve and Switched Patients with Retinal Diseases: Interim Results from a Post-Marketing Surveillance Study
Authors: Hyun Seung Yang, Se Joon Woo, Christopher Seungkyu Lee, Hyung-Il Kim, Kyu-Seop Kim, Kwan Hyuk Cho, Kwang Soo Kim, Inkyung Oh, Mercy Yeeun Kim, Juntae Kim, Daniel Duck-Jin Hwang
Presentation Type: paper on demand (Category: POD 1: AMD – Neovascular)

About BYOOVIZ

BYOOVIZ (ranibizumab-nuna) injection, for intravitreal use is a biosimilar to LUCENTIS (ranibizumab injection) 

INDICATIONS AND USAGE 

BYOOVIZ, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with:  

Neovascular (Wet) Age-Related Macular Degeneration (AMD)  Macular Edema Following Retinal Vein Occlusion (RVO)  Myopic Choroidal Neovascularization (mCNV)    IMPORTANT SAFETY INFORMATION 

 CONTRAINDICATIONS 

Ocular or periocular infections  Hypersensitivity 
   WARNINGS AND PRECAUTIONS

Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be monitored following the injection  Increases in intraocular pressure (IOP) have been noted both pre- and post intravitreal injection   There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors   ADVERSE REACTIONS 

The most common adverse reactions (reported more frequently in ranibizumab treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP   Please see full Prescribing information

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit www.samsungbioepis.com and follow us on LinkedIn and X.

About Harrow

Harrow, Inc. (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America, offering a comprehensive portfolio of products that address conditions affecting both the front and back of the eye, such as dry eye disease, wet (or neovascular) age-related macular degeneration, cataracts, refractive errors, glaucoma and a range of other ocular surface conditions and diseases of the retina. Harrow was founded with a commitment to deliver safe, effective, accessible, and affordable medications that enhance patient compliance and improve clinical outcomes. For more information about Harrow, please visit harrow.com and connect with us on LinkedIn.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward-looking statements.” Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, risks related to: liquidity or results of operations; our ability to successfully implement our business plan, develop and commercialize our products, product candidates and proprietary formulations in a timely manner or at all, identify and acquire additional products, manage our pharmacy operations, service our debt, obtain financing necessary to operate our business, recruit and retain qualified personnel, manage any growth we may experience and successfully realize the benefits of our previous acquisitions and any other acquisitions and collaborative arrangements we may pursue; competition from pharmaceutical companies, outsourcing facilities and pharmacies; general economic and business conditions, including inflation and supply chain challenges; regulatory and legal risks and uncertainties related to our pharmacy operations and the pharmacy and pharmaceutical business in general, including the ongoing communications with the U.S. Food and Drug Administration relating to compliance and quality plans at our outsourcing facility in New Jersey; physician interest in and market acceptance of our current and any future formulations and compounding pharmacies generally. These and additional risks and uncertainties are more fully described in Harrow’s filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2025, and other filings with the SEC. Such documents may be read free of charge on the SEC's web site at sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Harrow undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

MEDIA CONTACT – Samsung Bioepis
Anna Nayun Kim, [email protected]
Yoon Kim, [email protected]

MEDIA CONTACT – Harrow
Mike Biega
Vice President of Investor Relations and Communications
[email protected]
617-913-8890

1 Lucentis is a trademark of Genentech.
2026-07-20 11:51 1mo ago
2026-07-20 07:00 1mo ago
Harrow: IHEEZO snižuje bolest bez vyššího rizika infekce
HROW Harrow Health
FMP Stock News 78
Original source text
July 20, 2026 07:00 ET  | Source: Harrow, Inc.

NASHVILLE, Tenn., July 20, 2026 (GLOBE NEWSWIRE) -- Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, today announced the presentation of three studies supporting IHEEZO® (chloroprocaine HCl ophthalmic gel 3%), a broadly labeled low viscosity ocular anesthetic gel, and BYOOVIZ® (ranibizumab-nuna)i, an FDA-approved biosimilar referencing LUCENTISii (ranibizumab) at the American Society of Retina Specialists (ASRS) 2026 Annual Meeting. Collectively, the presentations expand the growing body of clinical and real-world evidence supporting Harrow's retina portfolio and reinforce Harrow’s commitment to generating quality evidence that strengthens physician confidence, improves patient experience, and supports long-term product adoption and innovation.

“ASRS is one of the premier scientific meetings in retina, and we're excited to share data that continues to strengthen the foundation supporting our growing retina franchise,” said Mark L. Baum, Chief Executive Officer of Harrow. “We believe durable commercial success is built on strong clinical evidence, generated before FDA-approval, and then robust supportive data sets subsequently produced. These studies further expand the evidence supporting IHEEZO while adding to the growing body of real-world experience for BYOOVIZ, reflecting our long-term commitment to retina specialists and the patients they treat.”

One presentation highlighted interim findings from an investigator-initiated, prospective, randomized study of 150 patients comparing IHEEZO versus subconjunctival lidocaine. While these preliminary data represent an early look at the data, investigators observed encouraging trends toward less post-procedure pain, a better post-injection patient experience, and fewer ocular symptoms through 24 hours following intravitreal injection among patients treated with IHEEZO. Harrow believes these early findings provide an encouraging signal supporting further investigation in a larger patient population.

Importantly, Harrow continues to enroll QUELL, a prospective, randomized, multi-center clinical trial of approximately 236 subjects that is being conducted under an active Investigational New Drug (IND) application. QUELL is designed to generate robust clinical evidence evaluating post-injection pain, patient experience, procedural performance, and safety in a substantially larger patient population, with topline data expected in the fourth quarter of 2026.

Another real-world study retrospectively evaluated whether IHEEZO's proprietary low-viscosity gel formulation interferes with antisepsis when used with chlorhexidine before intravitreal injection. Across nearly 20,000 injections, investigators observed no evidence of an increased endophthalmitis risk compared with a legacy tetracaine/povidone-iodine preparation. Although retrospective and not intended to demonstrate statistical superiority, the findings provide further confidence that physicians can realize the patient-experience benefits of IHEEZO's low-viscosity gel formulation without introducing additional procedural risk associated with antisepsis.

“These studies help build the scientific foundation supporting IHEEZO,” said Amir Shojaei, Chief Scientific Officer of Harrow. “The early interim randomized data suggest the potential to improve the patient experience, while the large real-world analysis provides reassuring evidence regarding procedural safety. We look forward to completing enrollment in QUELL, which we believe will provide the most comprehensive evaluation of IHEEZO in retina to date.”

Finally, Samsung Bioepis presented interim findings from a large-scale, real-world post-marketing surveillance study of BYOOVIZ. Full results from this study are being announced jointly with Samsung Bioepis today.

“Between the continued expansion of the clinical evidence supporting IHEEZO, the recent launch of BYOOVIZ, and the ongoing growth of our retina franchise, we believe Harrow is increasingly well-positioned as a trusted long-term partner to retina specialists,” Baum concluded. “We appreciated the opportunity to engage with physicians throughout ASRS and look forward to sharing additional updates later this year.”

IHEEZO® (chloroprocaine hydrochloride ophthalmic gel) 3%, for topical ophthalmic use

INDICATIONS AND USAGE 

IHEEZO is an ester anesthetic indicated for ocular surface anesthesia. 

IMPORTANT SAFETY INFORMATION 

CONTRAINDICATIONS 

IHEEZO is contraindicated in patients with a history of hypersensitivity to any component of
this preparation 

WARNINGS AND PRECATIONS 

Not for Injection or Intraocular Administration. Corneal Injury Due to Insensitivity. Corneal Opacification For Administration by Healthcare Provider: IHEEZO is not intended for patient self-administration  ADVERSE REACTIONS 

Most common adverse reaction is mydriasis (approximately 25%) 
Please see full Prescribing information

BYOOVIZ® (ranibizumab-nuna) injection, for intravitreal use is a biosimilar to LUCENTIS (ranibizumab injection) 

INDICATIONS AND USAGE 

BYOOVIZ, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with:

Neovascular (Wet) Age-Related Macular Degeneration (AMD)Macular Edema Following Retinal Vein Occlusion (RVO)Myopic Choroidal Neovascularization (mCNV)
 IMPORTANT SAFETY INFORMATION 

 CONTRAINDICATIONS 

Ocular or periocular infectionsHypersensitivity  WARNINGS AND PRECAUTIONS 

Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be monitored following the injectionIncreases in intraocular pressure (IOP) have been noted both pre- and post intravitreal injection There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors 
 ADVERSE REACTIONS 

The most common adverse reactions (reported more frequently in ranibizumab treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP 
 Please see full Prescribing Information 

About Harrow
Harrow, Inc. (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America, offering a comprehensive portfolio of products that address conditions affecting both the front and back of the eye, such as dry eye disease, wet (or neovascular) age-related macular degeneration, cataracts, refractive errors, glaucoma and a range of other ocular surface conditions and diseases of the retina. Harrow was founded with a commitment to deliver safe, effective, accessible, and affordable medications that enhance patient compliance and improve clinical outcomes. For more information about Harrow, please visit harrow.com and connect with us on LinkedIn.

About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit www.samsungbioepis.com and follow us on LinkedIn and X.

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward-looking statements.” Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, risks related to: liquidity or results of operations; our ability to successfully implement our business plan, develop and commercialize our products, product candidates and proprietary formulations in a timely manner or at all, identify and acquire additional products, manage our pharmacy operations, service our debt, obtain financing necessary to operate our business, recruit and retain qualified personnel, manage any growth we may experience and successfully realize the benefits of our previous acquisitions and any other acquisitions and collaborative arrangements we may pursue; competition from pharmaceutical companies, outsourcing facilities and pharmacies; general economic and business conditions, including inflation and supply chain challenges; regulatory and legal risks and uncertainties related to our pharmacy operations and the pharmacy and pharmaceutical business in general, including the ongoing communications with the U.S. Food and Drug Administration relating to compliance and quality plans at our outsourcing facility in New Jersey; physician interest in and market acceptance of our current and any future formulations and compounding pharmacies generally. These and additional risks and uncertainties are more fully described in Harrow’s filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2025, and other filings with the SEC. Such documents may be read free of charge on the SEC's web site at sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Harrow undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

Contacts:

Mike Biega
Vice President of Investor Relations and Communications
[email protected]
617-913-8890

i Byooviz is a trademark of Samsung Bioepis Co., Ltd.
ii Lucentis is a trademark of Genentech, Inc.
2026-07-01 12:12 2mo ago
2026-07-01 07:00 2mo ago
Samsung Bioepis znovu uvádí BYOOVIZ na trh v USA s Harrow
HROW Harrow Health
FMP Stock News 78
Original source text
INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. today announced the relaunch of BYOOVIZ® (ranibizumab-nuna) in the United States (US), in partnership with Harrow (Nasdaq: HROW). Harrow became responsible for commercialization of BYOOVIZ® (ranibizumab-nuna), a biosimilar referencing LUCENTIS1 (ranibizumab), and OPUVIZ™ (aflibercept-yszy), a biosimilar referencing EYLEA2 (aflibercept), upon full transition of commercialization rights from Biogen back to Samsung Bioepis by the end of 2025.

Today marks an exciting new chapter for BYOOVIZ in the US. As the first FDA-approved biosimilar to Lucentis, BYOOVIZ has already demonstrated its value in expanding access to critical retinal disease treatments.

Share BYOOVIZ was approved by the U.S. Food and Drug Administration (FDA) in September 2021 as the first ophthalmology biosimilar in the US for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), and Myopic Choroidal Neovascularization (mCNV).3 BYOOVIZ was granted interchangeability designation by the FDA in October 2023.4

Wet AMD affects approximately 1.2% to 1.3% of adults aged 65 and older in the US, with 1.5 million Americans living with the late, vision-threatening stages of the disease.5,6 Over the past two decades, anti-VEGF therapy has become a standard treatment for wet AMD.7 However, cost remains a significant financial burden for ranibizumab and other anti-VEGF treatments in the US.8 Biosimilars are biological products that are highly similar to existing FDA-approved reference products with no clinically meaningful differences in safety, purity, or potency and have the potential to alleviate the financial burden associated with current anti-VEGF therapies.9

“Today marks an exciting new chapter for BYOOVIZ in the US. As the first FDA-approved biosimilar to Lucentis, BYOOVIZ has already demonstrated its value in expanding access to critical retinal disease treatments. With Harrow now leading commercialization efforts, we are reigniting our commitment to ensuring patients and retina specialists across America to have access to this quality-proven, safe and effective biosimilar option,” said Linda Choi MacDonald, Executive Vice President and Global Head of Commercial, Samsung Bioepis. “We believe this relaunch will ultimately help more patients with critical ophthalmic diseases to receive the vision-saving treatments they need.”

In July 2025, Samsung Bioepis entered into partnership with Harrow for commercialization of BYOOVIZ and OPUVIZ in the US. Samsung Bioepis is responsible for development, regulatory registration, and manufacture of the products, while Harrow is responsible for commercialization.

BYOOVIZ was also approved as the first ophthalmology biosimilar by the European Commission and the United Kingdom in August 2021, and in Canada in March 2022. In Europe, Samsung Bioepis is responsible for direct commercialization of BYOOVIZ.

About BYOOVIZ (ranibizumab-nuna)

BYOOVIZ (ranibizumab-nuna) injection, for intravitreal use.
BYOOVIZ (ranibizumab-nuna) is an interchangeable biosimilar to LUCENTIS (ranibizumab injection).
BYOOVIZ, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with:
Neovascular (Wet) Age-Related Macular Degeneration (AMD)
Macular Edema Following Retinal Vein Occlusion (RVO)
Myopic Choroidal Neovascularization (mCNV)

Select Important Safety Information

WARNING AND PRECAUTIONS

Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be monitored following the injection.
Increases in intraocular pressure (IOP) have been noted both pre- and post-intravitreal injection.
There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.

ADVERSE REACTIONS

The most common adverse reactions (reported more frequently in ranibizumab treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP.

Please see Prescribing Information for BYOOVIZ (ranibizumab-nuna) HERE.

About OPUVIZ (aflibercept-yszy)

OPUVIZ (aflibercept-yszy) injection, for intravitreal use.
OPUVIZ (aflibercept-yszy) is an interchangeable biosimilar to EYLEA (aflibercept).
OPUVIZ is a vascular endothelial growth factor (VEGF) inhibitor, indicated for the treatment of patients with:
Neovascular (Wet) Age-Related Macular Degeneration (AMD)
Macular Edema Following Retinal Vein Occlusion (RVO)
Diabetic Macular Edema (DME)
Diabetic Retinopathy (DR)

Select Important Safety Information

WARNING AND PRECAUTIONS

Endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion may occur following intravitreal injections. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately.
Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection.
There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.

ADVERSE REACTIONS

The most common adverse reactions (≥5%) reported in patients receiving aflibercept were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased.

Please see Prescribing Information for OPUVIZ (aflibercept-yszy) HERE.

DISCLAIMER

This press release is intended solely for the purpose of sharing the availability of BYOOVIZ in the US. This document should not be construed as medical advice or as an endorsement of any product or treatment. Regulatory approval status and prescribing information may vary by country; please refer to local product information for any medicinal products mentioned herein. Information in this press release may include data on investigational compounds or unapproved indications. Such information is shared for scientific discussion purposes only and does not represent an assertion of safety or efficacy for any unapproved use.
This press release may contain forward-looking statements, including statements regarding clinical development programs, regulatory submissions, potential approvals, and future therapeutic potential. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially. Forward-looking statements are not guarantees of future performance. Samsung Bioepis undertakes no obligation to update any forward-looking statements contained in this press release.

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. As a wholly owned subsidiary of Samsung Epis Holdings, Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, endocrinology and neurology. For more information, please visit www.samsungbioepis.com and follow us on LinkedIn and X.

About Harrow

Harrow, Inc. (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America, offering a comprehensive portfolio of products that address conditions affecting both the front and back of the eye, such as dry eye disease, wet (or neovascular) age-related macular degeneration, cataracts, refractive errors, glaucoma and a range of other ocular surface conditions and diseases of the retina. Harrow was founded with a commitment to deliver safe, effective, accessible, and affordable medications that enhance patient compliance and improve clinical outcomes. For more information about Harrow, please visit harrow.com and connect with us on LinkedIn.

1 Lucentis is a trademark of Genentech, Inc.

2 Eylea is a trademark of Regeneron Pharmaceuticals, Inc.

3 U.S. Food and Drug Administration. FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions. Press Release. Sep 20, 2021. Available at: https://www.prnewswire.com/news-releases/fda-approves-first-biosimilar-to-treat-macular-degeneration-disease-and-other-eye-conditions-301380552.html (Accessed June 2026)

4 U.S. Food and Drug Administration. Supplement Approval for Byooviz (ranibizumab-nuna) injection 0.5 mg (10 mg/mL) for intravitreal injection (BLA 761202/S-006). Available at: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761202Orig1s006ltr.pdf (Accessed June 2026)

5 Saundankar V, Borns M, Broderick K, Shah B, Cowburn S, McFadden S, Suehs B. Annual prevalence of geographic atrophy and wet age-related macular degeneration among Medicare Advantage enrollees in a US health plan. J Manag Care Spec Pharm. 2025 Jan;31(1):88-94. doi: 10.18553/jmcp.2025.31.1.88. PMID: 39745845; PMCID: PMC11695844.

6 Center for Disease Control and Prevention. Vision and Eye Health Surveillance System. VEHSS Modeled Estimates: Age-Related Macular Degeneration (AMD). Available at: https://www.cdc.gov/vision-health-data/prevalence-estimates/amd-prevalence.html (Accessed June 2026)

7 Kovach JL, Schwartz SG, Flynn HW Jr, Scott IU. Anti-VEGF Treatment Strategies for Wet AMD. J Ophthalmol. 2012;2012:786870. doi: 10.1155/2012/786870. Epub 2012 Feb 28. PMID: 22523653; PMCID: PMC3317200.

8 Tabano D, Watane A, Gale R, Cox O, Hill SR, Longworth L, Oluboyede Y, Ahmed A, Patel NA. The Economic Burden of Anti-Vascular Endothelial Growth Factor on Patients and Caregivers in the UK, Europe, and North America. Ophthalmol Ther. 2025 Aug;14(8):1869-1892. doi: 10.1007/s40123-025-01180-5. Epub 2025 Jun 28. PMID: 40580375; PMCID: PMC12270987.

9 U.S. Food and Drug Administration. Biosimilars: Overview for Health Care Professionals. Available at: https://www.fda.gov/drugs/biosimilars/overview-health-care-professionals (Accessed June 2026)

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