Ranibizumab-nuna

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 LUCENTIS ii (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. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); 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 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 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 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 mbiega@harrowinc.com 617-913-8890 i Byooviz is a trademark of Samsung Bioepis Co., Ltd. ii Lucentis is a trademark of Genentech, Inc.

Samsung Bioepis has announced the relaunch of Byooviz (ranibizumab-nuna) in the United States in partnership with Harrow. In July 2025, Samsung Bioepis entered into a commercialization agreement with Harrow for Byooviz, a biosimilar referencing ranibizumab (Lucentis; Genentech), and Opuviz (aflibercept-yszy), a biosimilar referencing aflibercept (Eylea; Regeneron). Following the full transition of commercialization rights from Biogen back to Samsung Bioepis at the end of 2025, Harrow assumed responsibility for commercialization of both products in the United States, while Samsung Bioepis remains responsible for their development, regulatory registration, and manufacturing, according to a company press release. Byooviz was approved by the US Food and Drug Administration (FDA) in September 2021 as the first ophthalmic biosimilar in the United States for the treatment of neovascular age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. The FDA granted Byooviz an interchangeability designation in October 2023. Outside the United States, Byooviz was approved by the European Commission and the United Kingdom in August 2021, and in Canada in March 2022. Samsung Bioepis is responsible for the product's direct commercialization in Europe. RP