Harrow Announces Commercial Launch Of BYOOVIZ, FDA-Approved Biosimilar Referencing LUCENTISi And Developed By Samsung Bioepis

Harrow (NASDAQ: HROW ), a leading provider of ophthalmic disease management solutions in North America, today announced the commercial launch of BYOOVIZ® (ranibizumab-nuna), an FDA-approved biosimilar referencing LUCENTISi (ranibizumab) and developed by Samsung Bioepis Co., Ltd.

The launch follows Harrow's exclusive U.S. commercialization agreement with Samsung Bioepis, one of the world's leading biosimilar developers and manufacturers.

Through this partnership, Harrow obtained exclusive U.S. rights to commercialize BYOOVIZ and OPUVIZ® (aflibercept-yszy), an FDA-approved biosimilar referencing EYLEAii (aflibercept), further strengthening the Company's position in the rapidly growing retinal biologics market.

BYOOVIZ was approved by the U.S.

Food and Drug Administration (FDA) as the first ophthalmology biosimilar in the U.S. 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).

As an FDA-designated interchangeable biosimilar to LUCENTIS, BYOOVIZ provides retina specialists with a clinically proven anti-VEGF therapy that offers confidence, flexibility, and choice in patient care.

The launch of BYOOVIZ marks another important step in the evolution of Harrow's market-leading retina franchise.

With an estimated $9 billion U.S. anti-VEGF marketiii and increasing demand for therapies that treat sight-threatening retinal diseases, Harrow continues to build a differentiated portfolio of buy-and-bill products designed specifically for the needs of retina specialists and the patients they serve.

BYOOVIZ joins Harrow's expanding retina franchise, which includes IHEEZO® (chloroprocaine hydrochloride 3% ophthalmic gel), a branded FDA-approved ocular anesthetic indicated for ocular surface anesthesia that is increasingly utilized by retina specialists during intravitreal injection procedures, and TRIESENCE® (triamcinolone acetonide injectable suspension) 40 mg/ml, a high-trust preservative-free injectable corticosteroid, broadly labeled and increasingly used by retina specialists nationwide.

Together, these products enable Harrow to support both the procedural and therapeutic aspects of retinal disease management, providing retina practices with a trusted commercial partner across multiple points of care.