"The DSMB has recommended moving forward to dose subsequent subjects with Stargardt disease at the targeted high dose," said Dr. Peter Y. Chang, MD, FACS, DSMB Chair for the OCU410ST clinical trial. "No serious adverse events (SAEs) related to OCU410ST have been reported to date. This is an important next step in the clinical progress for OCU410ST and encouraging for patients living with this most common form of inherited retinal disease." Contact: Tiffany Hamilton Head of Communications Tiffany.Hamilton@oc ...

Luminance Dependent Navigation Assessment (LDNA)—a more sensitive and specific measurement of function than MLMT used in previous Phase 3 clinical trials—is the primary endpoint for the study. The Phase 3 liMeliGhT study will focus on the proportion of responders, in treated and untreated groups, achieving an improvement of at least 2 Lux levels from baseline in the study eyes. "Each clinical milestone achieved by OCU400 brings us closer to providing a one-time treatment for life to patients living with RP, ...

Core Viewpoint - Ocugen, Inc. has initiated the Phase 3 liMeliGhT clinical trial for OCU400, a gene therapy product aimed at treating retinitis pigmentosa (RP), with the first patient dosed, marking a significant milestone in the development of potential treatments for this condition [3][11]. Company Overview - Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines to improve health and offer hope to patients globally [9]. - The company is advancing research in various areas, including retinal diseases, infectious diseases, and orthopedic diseases, with a unique modifier gene therapy platform that has the potential to treat multiple retinal diseases with a single product [9]. Clinical Trial Details - The Phase 3 liMeliGhT study will evaluate the efficacy of OCU400, focusing on the proportion of responders achieving an improvement of at least 2 Lux levels from baseline in treated and untreated groups [1]. - The study will include 150 participants, divided into two arms: one with RHO gene mutations and the other gene-agnostic, with a randomization of 2:1 to treatment and control groups [11]. - The trial duration is set for one year, targeting patients aged eight years and older with varying stages of RP [11]. Previous Clinical Data - Positive results from Phase 1/2 trials indicated that 89% of RP subjects showed preservation or improvement in visual acuity or mobility testing scores [5]. - Specifically, 80% of subjects with RHO mutations experienced preservation or improvement in mobility testing scores [5]. Therapeutic Potential - OCU400 is positioned as a novel modifier gene therapy that could significantly change the treatment landscape for RP, providing long-term benefits to patients who currently have no therapeutic options [4]. - The therapy aims to restore homeostasis in the retina, potentially improving retinal health and function for patients with RP and other retinal diseases [7][8]. Regulatory Status - OCU400 has received orphan drug and RMAT designations from the FDA, and the EMA has accepted the U.S.-based trial for submission of a Marketing Authorization Application (MAA) [6].

SO WHAT: If you purchased Ocugen securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement. No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor's ability to share in any potential future recovery is not dependent upon servi ...

NEW YORK, June 6, 2024 /PRNewswire/ -- Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Ocugen, Inc. ("Ocugen" or the "Company") (NASDAQ: OCGN) and reminds investors of the June 10, 2024 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company. Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses Exceeding $75,000 In Ocugen To Conta ...

NEW YORK, June 05, 2024 (GLOBE NEWSWIRE) -- Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Ocugen, Inc. ("Ocugen" or the "Company") (NASDAQ: OCGN) and reminds investors of the June 10, 2024 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company. Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses Exceeding $75,000 In Ocugen To ...

Ocugen, Inc. (OCGN) is having a phenomenal run in the year so far. Shares of the company have skyrocketed 209.6% year to date against the industry's decline of 5.6%. The significant surge can be attributed to its encouraging pipeline progress. Ocugen is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines. The company is developing a modifier gene therapy platform designed to fulfill the significant medical needs related to retinal diseas ...

LOS ANGELES, June 4, 2024 /PRNewswire/ -- The Schall Law Firm, a national shareholder rights litigation firm, reminds investors of a class action lawsuit against Ocugen, Inc. ("Ocugen" or "the Company") (NASDAQ: OCGN) for for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission. Investors who purchased the Company's securities between May 8, 2020 and April 1, 2024, inclusive (the "Class Period"), are encou ...

NEW YORK, June 3, 2024 /PRNewswire/ -- WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Ocugen, Inc. (NASDAQ: OCGN) between May 8, 2020 and April 1, 2024, both dates inclusive (the "Class Period"), of the important June 10, 2024 lead plaintiff deadline in the securities class action first filed by the Firm. SO WHAT: If you purchased Ocugen securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs throu ...

ATLANTA, June 03, 2024 (GLOBE NEWSWIRE) -- A shareholder class action lawsuit has been filed against Ocugen, Inc. ("Ocugen" or the "Company") (NASDAQ: OCGN). The lawsuit alleges that Defendants made materially false and misleading statements and/or failed to disclose material adverse information regarding the Company's business, operations, and prospects, including allegations that: (1) Ocugen's financial statements from May 8, 2020 to the present were materially misstated; and (2) Ocugen did not have adequ ...