Ocugen Inc - OCGN STOCK NEWS

Ocugen (NASDAQ: OCGN) has completed dosing in the Phase 2 portion of its Phase 1/2 ArMaDa clinical trial for OCU410, a novel gene therapy for geographic atrophy (GA), an advanced form of dry age-related macular degeneration (dAMD). The trial enrolled 51 subjects randomized into treatment and control arms.

The Phase 1/2 study (N=60) showed promising results with a 44% slower lesion growth in treated eyes versus untreated eyes at 9 months, and a clinically meaningful 2-line improvement in visual function. The therapy demonstrated a favorable safety profile with no serious adverse events.

OCU410 is designed as a one-time treatment, targeting multiple disease pathways, unlike current U.S. treatments that require monthly or bi-monthly injections. The trial is being conducted at 14 leading retinal surgery centers across the U.S., with Phase 3 studies planned for 2026 and potential BLA/MAA filings by 2028.

Ocugen (NASDAQ: OCGN) has received a positive opinion from the European Medicines Agency's Committee for Advanced Therapies (CAT) for OCU400's Advanced Therapy Medicinal Product (ATMP) classification. OCU400, the first gene therapy to enter Phase 3 with a broad retinitis pigmentosa (RP) indication, is currently in its Phase 3 liMeliGhT clinical trial.

The trial involves 150 participants divided into two arms: 75 with RHO gene mutations and 75 gene agnostic, with 2:1 randomization to treatment versus control groups. The ATMP classification accelerates regulatory review and enables more frequent EMA interactions as Ocugen plans for Marketing Authorization Application filing in 2026.

Both FDA and EMA have confirmed that a single pivotal Phase 3 trial will suffice for regulatory submissions. Ocugen aims to file simultaneously in the U.S. and Europe, targeting market entry by 2027. RP affects approximately 310,000 patients in the U.S., EU, and Canada, with no current treatments available to slow or stop progression for multiple forms of the disease.

Ocugen (NASDAQ: OCGN) announced that the FDA has cleared their Investigational New Drug (IND) application for OCU500, a first-in-class inhaled COVID-19 vaccine. The Phase 1 clinical trial, scheduled to begin in Q2 2025, will be sponsored by NIAID under Project NextGen to evaluate safety, tolerability, and immunogenicity.

The trial will enroll 80 adults aged 18-64, split into low and high-dose groups, testing both inhalation and intranasal spray delivery methods. The vaccine uses novel chimpanzee adenovirus-vectored (ChAd36) technology licensed from Washington University. CDC data shows COVID-19 remains significant, with 4.4-7.9 million infections and 14,000-25,000 deaths from October 2024 to January 2025.

NIAID will fully fund the Phase 1 trial through Project NextGen's $5 billion initiative. Ocugen plans to expand this mucosal platform to address other respiratory threats including seasonal influenza, bird flu, and RSV.

Ocugen (NASDAQ: OCGN) has initiated the Phase 1 clinical trial of OCU200 for diabetic macular edema (DME) with the first patient dosed. The trial is a multicenter, open-label, dose-escalation study evaluating three dosage levels: 0.025 mg, 0.05 mg, and 0.1 mg, with patients receiving two intravitreal injections six weeks apart.

OCU200 is a novel recombinant fusion protein targeting integrin receptors, designed to treat DME, diabetic retinopathy (DR), and wet age-related macular degeneration (wet AMD). The treatment aims to address an unmet need, particularly for the 30-40% of patients who don't respond to current anti-VEGF therapies. These conditions affect approximately 12 million people in the US and 130 million worldwide.

The company plans to pursue OCU200's approval as a first-line therapy for all three conditions, with patient follow-up extending to three months post-treatment.

Ocugen (NASDAQ: OCGN) announced positive 2-year data from its Phase 1/2 clinical trial of OCU400, a novel modifier gene therapy for retinitis pigmentosa (RP). The trial showed that 100% of treated subjects (9/9) demonstrated improvement or preservation in visual function compared to untreated eyes at both one and two years.

Key findings include statistically significant improvement in visual function across multiple mutations (p=0.01), with meaningful improvement of 2-line gain in low-luminance visual acuity. The therapy showed a favorable long-term safety profile with no serious adverse events. OCU400 aims to treat approximately 2 million patients globally (~300,000 in U.S./EU) with a one-time therapy.

The company's Phase 3 OCU400 liMeliGhT clinical trial is ongoing, with BLA submission targeted for first half of 2026.

Ocugen (NASDAQ: OCGN) announced positive safety data from the Data and Safety Monitoring Board (DSMB) review of their OCU410 ArMaDa Phase 1/2 clinical trial for geographic atrophy (GA) secondary to dry age-related macular degeneration (dAMD). The DSMB assessed data from 15 Phase 2 subjects, finding OCU410 to be safe and well-tolerated with no serious adverse events reported.

The Phase 2 study involves 45 subjects randomized across two treatment groups and one control group. Unlike current GA treatments requiring 6-12 annual injections, OCU410 aims to be a one-time treatment. The trial showed promising Phase 1 results, including reduced lesion growth, preserved retinal tissue, and improved low luminance visual acuity. The study is being conducted at 13 retinal surgery centers across the U.S., with dosing expected to complete in early 2025.

Ocugen (NASDAQ: OCGN) announced that CEO Dr. Shankar Musunuri will present at the Oppenheimer Movers in Rare Disease Summit on December 12, 2024, at the Westin Grand Central, New York. The presentation will focus on the company's progress in developing modifier gene therapies for inherited retinal diseases.

Dr. Musunuri will discuss two key programs: the Phase 3 OCU400 liMeliGhT clinical trial for retinitis pigmentosa (RP) and the Phase 1/2 OCU410ST GARDian clinical trial for Stargardt disease. The presentation is scheduled for 2:45-3:30 p.m. ET in the Grand Central Ballroom C&D. Company executives will also conduct one-on-one meetings with investors to discuss business and clinical development strategies.

Ocugen (NASDAQ: OCGN) announced that Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder, will present at NobleCon20 – Noble Capital Markets' 20th Annual Emerging Growth Equity Conference. The presentation is scheduled for December 3, 2024, at 1:30 p.m. ET at Florida Atlantic University in Boca Raton, FL.

The event will feature a presentation and moderated Q&A session, where Dr. Musunuri will provide updates on Ocugen's clinical programs. The company's executive team will also conduct one-on-one meetings with investors to discuss their business and clinical development strategy for their modifier gene therapy platform.

A video webcast will be available the following day on Ocugen's website, Noble Capital Markets' Conference website, and Channelchek, remaining accessible for 90 days.

Ocugen announced that the European Medicines Agency (EMA) has granted orphan medicinal product designation for OCU410ST to treat ABCA4-associated retinopathies including Stargardt disease. The designation offers benefits including protocol assistance, reduced fees, research grants, and 10 years of market exclusivity. Phase 1 dosing of the Phase 1/2 OCU410ST GARDian trial is complete, with the DSMB recommending progression to Phase 2. Preliminary data showed an 84% reduction in atrophic lesion growth in treated eyes versus untreated eyes. The treatment targets approximately 100,000 patients in the U.S. and Europe combined. OCU410ST previously received FDA orphan drug designation in April 2023.