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	Saved 2026-07-20 14:15 6d ago Published 2026-07-20 08:00 6d ago	Samsung Bioepis uvádí srovnatelnou bezpečnost SB11 s ranibizumabem Samsung Bioepis a Harrow uvedly, že průběžná data ze studie fáze 4 ukazují srovnatelnou bezpečnost SB11 s ranibizumabem. U dosud neléčených pacientů navíc došlo ke zlepšení BCVA i CST, bez nových bezpečnostních signálů. 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.
	Saved 2026-07-20 11:51 6d ago Published 2026-07-20 07:00 6d ago	Harrow: IHEEZO snižuje bolest bez vyššího rizika infekce Harrow na ASRS 2026 představila tři studie podporující IHEEZO a BYOOVIZ. U IHEEZO data naznačila méně bolesti po zákroku a žádné zvýšení rizika endoftalmitidy. 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.
	Saved 2026-07-01 12:12 25d ago Published 2026-07-01 07:00 25d ago	Samsung Bioepis znovu uvádí BYOOVIZ na trh v USA s Harrow Samsung Bioepis znovu uvádí BYOOVIZ na trh v USA v partnerství s Harrow. Harrow převezme komercializaci biosimilárního přípravku k Lucentis. 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) More News From Samsung Bioepis Co., Ltd.