Ocugen Gains Bahamas Approval Pathway For OCU400 Retinitis Pigmentosa Therapy

Ocugen (OCGN) announced its gene therapy OCU400 received provisional approval in the Bahamas, aiming to treat the first retinitis pigmentosa patient within 90 days. Shares rose 3%. The company expects Phase 3 trial results in Q1 2027 and a U.S. BLA submission in Q2. Ocugen has other late-stage eye-disease programs and expects cash runway through 2028.

Kowa Pharmaceuticals' NDA for K-911, an IOP-lowering eye drop, was accepted by the FDA, with a PDUFA target date of April 30, 2027. Ocugen dosed the first patient in a Phase 3 trial for OCU410, a gene therapy for dry AMD. Bausch + Lomb surveyed awareness of dry eye in menopause, finding low recognition. ASCRS announced events and policy statements. Research highlighted KLEx-CXL outcomes and enVista Aspire IOL performance.

Ocugen, Inc. (OCGN) shares fell slightly as the company announced the first patient was dosed in a global Phase 3 trial for OCU410, a gene therapy candidate for dry age-related macular degeneration. The FDA granted OCU410 RMAT designation, potentially accelerating development. Ocugen aims to offer a one-time treatment for the condition, with no approved treatments outside the U.S. and limited options in the U.S.

Ocugen, Inc. (OCGN) shares fell slightly as the company announced the first patient was dosed in its global Phase 3 trial for OCU410, a gene therapy for dry age-related macular degeneration. The FDA granted RMAT designation to OCU410, potentially accelerating development. The trial follows a successful End-of-Phase 2 meeting with the FDA.

Ocugen, Inc. (OCGN) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Ocugen Provides Business Update with Second Quarter 2026 Financial Results Conference Call and Webcast Today at 8:30 a.m. ET · Received U.S. Food and Drug Administration (FDA) clearance to initiate OCU410 Phase 3 trial for geographic atrophy (GA), secondary to dry ag

Ocugen (NASDAQ: OCGN) said it signed a binding term sheet to negotiate an exclusive license for its OCU400 modifier gene therapy for retinitis pigmentosa in the Middle East and North Africa with Roots Pharmaceutical and Al-Dhow International Holding. Ocugen expects up to $4 million in upfront and near-term milestones, up to $255 million in sales milestones, and 22% royalties on net sales. Ocugen will manufacture OCU400, with a definitive deal expected within 90 days.