LYNX-2 Follows SPA Agreement with FDA Development of PS is Funded by Ocuphire’s Partner Viatris FARMINGTON HILLS, Mich., April 11, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage biopharmaceutical company focused on developing novel therapies for the treatment of unmet needs of patients with retinal and refractive eye disorders, today announced the enrollment of the first subject in the LYNX-2 Phase 3 registration study evaluating Phentolamine Ophthalmic Solution 0.75% (PS) for the treatment of decreased visual acuity under low (mesopic) light conditions following keratorefractive surgery.

LYNX-2遵循与FDA达成的SPA协议PS的开发由Ocuphire的合作伙伴Viatris FARMINGTON HILLS，Mich.，2024年4月11日（环球通讯社）-Ocuphire Pharma，Inc.（纳斯达克：OCUP）资助，Ocuphire Pharma，Inc.（纳斯达克：OCUP），一家临床阶段生物制药公司，专注于开发新的治疗视网膜和屈光性眼病患者未满足需求的疗法，今天宣布在LYNX-2 3期注册研究中招募第一名受试者，评估酚妥拉明眼用溶液0.75%（PS）治疗屈光手术后低（中）光条件下视力下降。

The LYNX-2 trial is being conducted under conditions of a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). As previously announced, Ocuphire received written agreement from the FDA that the clinical trial protocol and planned statistical analysis of the LYNX-2 Phase 3 trial would adequately address objectives supporting regulatory submission and a potential future marketing application in this indication.

LYNX-2试验是在美国食品和药物管理局（FDA）的特别方案评估（SPA）的条件下进行的。正如之前宣布的那样，Ocuphire收到了FDA的书面协议，即LYNX-2 3期试验的临床试验方案和计划的统计分析将充分解决支持监管提交的目标以及该适应症未来潜在的营销应用。

“We are pleased to begin enrollment in the LYNX-2 study of PS,” said George Magrath, M.D., M.B.A., M.S., CEO of Ocuphire. “If our registration program meets expectations, and PS is subsequently approved by the FDA, it could potentially be the first commercial treatment for patients who have undergone LASIK surgery and experience low light visual disturbances.

Ocuphire首席执行官乔治·马格拉斯（GeorgeMagrath）医学博士、工商管理硕士、硕士说：“我们很高兴开始参加LYNX-2 PS研究。”。“如果我们的注册计划符合预期，PS随后得到FDA的批准，它可能是接受LASIK手术并经历低光视力障碍的患者的第一种商业治疗。

We believe that PS is a product with broad potential applications in ophthalmology. Having already received approval for RYZUMVI™ to treat pharmacologically-induced mydriasis, our partner Viatris, Inc. (Viatris) now has the opportunity to create further value as it pursues additional indications for PS, which also include presbyopia.” Vision disturbances under .

我们相信PS是一种在眼科具有广泛潜在应用的产品。我们的合作伙伴Viatris，Inc.（Viatris）已经获得RYZUMVI™治疗药理学引起的瞳孔散大的批准，现在有机会创造进一步的价值，因为它寻求PS的其他适应症，其中也包括老视。”视力障碍。