Ocugen clinical trials. Ocugen Inc.

Ocugen clinical trials. Announces First Patient Dosed in Phase 3 liMeliGhT Clinical Trial for OCU400—First Gene Therapy in Phase 3 MALVERN, Pa. announced significant advancements in its clinical programs and financial results during a conference call on August 1, 2025, highlighting Ocugen, a gene therapy company, received FDA clearance to begin a Phase 2/3 trial for OCU410ST, a modifier gene therapy for Stargardt disease (ABCA4 Ocugen, Inc. A Ocugen, Inc. , July 18, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. has dosed its first patient in the phase 3 liMeliGhT clinical trial for OCU400—an investigational candidate for the treatment of retinitis pigmentosa (RP) Ocugen has received FDA approval to begin a Phase 1 clinical trial for OCU500, an inhaled and nasal spray vaccine for COVID-19. This candidate is a novel multifunctional modifier Ocugen has commenced its Phase 3 liMeliGhT clinical trial for OCU400 gene therapy for retinitis pigmentosa (RP). m. This is a multicenter study, Conference Call and Webcast Today at 8:30 a. Announces Positive 2-Year Data Across Multiple Mutations from Phase 1/2 Clinical Trial of OCU400 —A Novel Modifier Gene Therapy for Retinitis Pigmentosa Ocugen Announces Phase 3 Confirmatory Clinical Trial Agreement for NeoCart® Important next step for Ocugen’s regenerative cell therapy in orthopedics since announcing MALVERN, Pa. The Ocugen received approval from the FDA for an amendment to their IND application, which will enable them to commence a phase 3 clinical trial “The early results from patients treated in the Phase 1/2 clinical trial are encouraging and support the paradigm-changing potential of modifier gene therapy technology OCU500 was selected by the NIH/NIAID Project NextGen for inclusion in clinical trials. Ocugen, Inc. This is a Ocugen, Inc. Louis, is set to begin a Phase 1 clinical trial in the Ocugen has dosed the first subject in a multicentre Phase I trial of OCU200 for diabetic macular oedema (DMO) treatment. ET OCU400 Phase 3 clinical trial for retinitis pigmentosa (RP) is progressing well and on target for potential BLA/MAA filings by Ocugen is a clinical-stage biopharmaceutical corporation that specializes in discovering, developing, and commercializing gene therapies to treat blinding diseases. The Data Safety and Monitoring Board (DSMB) has granted approval for progression to the medium dose in Ocugen’s OCU410ST clinical Ocugen Inc today announced the FDA has cleared its Investigational New Drug (IND) amendment to initiate a Phase 3 clinical trial of Ocugen announced the Data and Safety Monitoring Board (DSMB) for the OCU200 clinical trial convened following dosing of the first cohort in the dose-escalation portion of the This is a Phase 3 study to Assess the Efficacy, Safety and Tolerability of OCU400 in patients with retinitis pigmentosa (RP) associated with RHO mutations and patients with any Ocugen has announced the completion of subject dosing in the first cohort of its Phase I/II ArMaDa clinical trial of gene therapy candidate OCU410 Ocugen, Inc. Announces FDA Alignment on Phase 2/3 Pivotal Confirmatory Clinical Trial for Modifier Gene Therapy Candidate OCU410ST Clinical trials & studies for OxygenThe main goal of this study is to look at the performance of the neonatal, infant, and pediatric Philips SpO2 sensors with the Philips FAST Ocugen has announced the completion of subject dosing in the first cohort of its Phase I/II GARDian clinical trial of OCU410ST (AAV5- hRORA), a modifier gene therapy The ArMaDa clinical trial is currently being performed at 13 leading retinal surgery centers across the U. This is a multicenter study, which will be conducted in two phases and will enroll up to a total References: Ocugen, Inc. The Investigational New Drug application is in effect for OCU500, and Ocugen also has two Phase 1/2 clinical trials underway for its modifier gene therapies for people with geographic atrophy (GA) associated with advanced dry age-related Announcement marks first clinical trial in humans of Ocugen’s modifier gene therapy platform MALVERN, Pa. By following these steps and maintaining a The Phase 3 liMeliGhT clinical trial was informed by positive Phase 1/2 OCU400 data that suggests positive trends in Best-Corrected Visual Acuity Ocugen announced that the first patient has been dosed in its phase 3 liMeliGhT clinical trial for OCU400, a modifier gene therapy product . , July 25, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. Ocugen will be responsible for providing clinical trial materials and upon completion will have full right of reference to the findings, which Ocugen believes will provide clinical Ocugen receives DSMB approval to continue dosing in Phase I trial of OCU200 The open-label trial aims to evaluate the drug's safety when Ocugen, Inc. Successful outcomes will provide tremendous Phase I/II trials for Ocugen’s gene therapies, OCU410 and OCU410ST, are planned for initiation by the end of 2023 in geographic Ocugen’s OCU500, a mucosal COVID-19 vaccine, enters Phase 1 trial; focuses on inhalation and nasal spray administration. has dosed its first patient in the phase 3 liMeliGhT clinical trial for OCU400—an investigational candidate for the treatment of retinitis pigmentosa (RP) The biotech company Ocugen has announced that the US Food & Drug Administration has provided clearance for launch of its Phase 3 liMeliGhT clinical trial for Ocugen Clinical Showcase Highlighting Progress in Retinal Gene Therapy Clinical Trials in New York City on Tuesday, November 12, 2024 The US Food and Drug Administration (FDA) has approved Ocugen’s investigational new drug (IND) amendment to initiate a Phase II/III Ocugen is building a current Good Manufacturing Practice cell therapy manufacturing facility to support establishment of the clinical and commercial manufacturing Ocugen co-founder, CEO and chairman Dr Shankar Musunuri said: “Dosing the first patient is an especially significant milestone and brings us closer to our goal of addressing the The GARDian3 clinical trial builds upon encouraging results and positive data from the Phase 1 GARDian trial, which demonstrated 48% slower lesion growth at 12-month follow The participant provided permission for Ocugen to use his image and voice in this video. announced that the Data and Safety Monitoring Board (DSMB) for the OCU410 ArMaDa clinical trial recently convened and approved continuation of the second Ocugen reports progress in clinical trials for its gene therapies targeting retinitis pigmentosa and Stargardt disease, with upcoming regulatory filings. FDA Acceptance of Investigational New Drug Application to Initiate a Phase 1/2 Clinical Trial for Gene Therapy Candidate OCU400 to Treat Quiver AI Summary Ocugen, Inc. The Company is planning to initiate the OCU200 Phase I Ocugen announced that dosing is complete in the second cohort of its phase 1/2 GARDian clinical trial for OCU410ST (AAV-hRORA)—a modifier gene therapy candidate being Ocugen announces positive clinical study update from the phase 1/2 trial of OCU400, a modifier gene therapy product candidate, for the Ocugen received FDA clearance to initiate a Phase 3 clinical trial for OCU400, marking the first gene therapy to enter Phase 3 with a broad retinitis pigmentosa indication. announced the positive 2-year safety and efficacy update for the Phase 1/2 OCU400 clinical trial for the treatment of early to Ocugen reported clinical trial progress and financial results, highlighting advancements in gene therapies for retinal diseases and recent FDA alignments. Ocugen Inc announced that Health Canada provided a MALVERN, Pa. Title: Safety and Efficacy Results from a Phase 1/2 Clinical Trial of OCU400 Modifier Gene Ocugen reported clinical trial progress and financial results, highlighting advancements in gene therapies for retinal diseases and recent FDA alignments. Announces Investigational New Drug Application in Effect After Review by FDA to Initiate Phase 1 Clinical Trial Evaluating First-in-Class OCU500 Inhaled This is a Phase 3 study to Assess the Efficacy, Safety and Tolerability of OCU400 in patients with retinitis pigmentosa (RP) associated Ocugen Announces Dosing Completion of Subjects with Stargardt Disease in Cohort 2 of Phase 1/2 GARDian Clinical Trial of OCU410ST—A Modifier Gene Therapy May Ocugen is actively dosing patients at least 8 years of age in the liMeliGhT clinical trial, starting with the first patient who was dosed in July MALVERN - Ocugen, Inc. — Ocugen, Inc. Announces U. Announces Completion of Dosing in Subjects with Geographic Atrophy Secondary to dAMD in High-Dose Cohort of Phase 1/2 ArMaDa Clinical Trial of OCU410—A The Phase 2/3 clinical trial will randomize 51 subjects, 34 of whom will receive a single, subretinal, 200-μL injection of OCU410ST at a Ocugen announced positive results from cohort 1 of the phase 1/2 ArMaDa clinical trial, designed to assess the safety of unilateral subretinal administration of OCU410 in Ocugen (NASDAQ: OCGN) announced that the FDA has cleared their Investigational New Drug (IND) application for OCU500, a first-in-class inhaled COVID-19 OCU500 will be administered via inhalation and as a nasal spray COVID-19 remains a substantial public health threat in the U. has announced encouraging 2-year safety and efficacy results from its Phase 1/2 clinical trial of OCU400, a novel gene therapy for the treatment of retinitis Ocugen, Inc. This is a Phase 2 Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration (AMD). Announces FDA Approval of Expanded Access Program for Patients with Retinitis Pigmentosa August 05, 2024 06:30 ET | Source: Ocugen This is a Phase 2/3 Study to Assess the Safety and Efficacy of OCU410ST for Stargardt Disease. The trial, sponsored by the National Institute of Ocugen’s OCU400, an investigational gene therapy product based on the company’s Modifier Gene Therapy Platform, has demonstrated the The product candidate is a modifier gene therapy for broad retinitis pigmentosa indication. announces US FDA clearance of Investigational New Drug Amendment to initiate phase 2/3 pivotal confirmatory Helpful Links Provided by Ocugen Retina World Congress 2024- Meeting Abstract. S. Nothing in this video is intended to suggest that OCU400 has been Location: Hyatt Regency Seattle The OCU400 Phase 3 liMeliGhT clinical trial is currently underway and on track to meet the Company’s 2026 BLA and MAA approval targets. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, Ocugen progresses to Phase 2 of the OCU410 ArMaDa trial, evaluating a one-time gene therapy for geographic atrophy in dry AMD patients. has announced encouraging 2-year safety and efficacy results from its Phase 1/2 clinical trial of OCU400, a novel gene therapy for the treatment of retinitis Notably, 3 of 5 intent-to-treat (ITT) RHO subjects (60%) from the Phase 1/2 trial meet the new “responder” criteria established in collaboration with the FDA for REFERENCES 1. announced a clinical study update for retinitis pigmentosa (RP) participants treated in the Phase 1/2 trial to assess the safety Ocugen has announced that the first patient in its Phase 1 clinical trial for OCU200, a potential treatment for diabetic macular edema (DME), has The success of Ocugen’s stock is a result of a combination of strategic partnerships, successful clinical trials, and strong leadership. This is a Phase 3 study to Assess the Efficacy, Safety and Tolerability of OCU400 in patients with retinitis pigmentosa (RP) associated with RHO mutations and This is a Phase 3 study to Assess the Efficacy, Safety and Tolerability of OCU400 in patients with retinitis pigmentosa (RP) associated with RHO mutations and patients with any Ocugen, Inc. Biotechnology company Ocugen has completed dosing in the second cohort of its Phase I/II ArMaDa clinical trial of modifier gene therapy Ocugen is now spearheading the clinical trials necessary to bring this therapy closer to patients. Ocugen Clinical Showcase Highlighting Progress in Retinal Gene Therapy Clinical Trials in New York City on Tuesday, November 12, 2024 October 28, 2024 06:30 ET | Source: The ArMaDa Phase 1/2 clinical trial will assess the safety of unilateral subretinal administration of OCU410 in subjects with GA and will be conducted in two phases. announced significant advancements in its clinical programs and financial results during a conference call on August 1, 2025, highlighting its ongoing OCU400 is intended for the treatment of early to advanced retinitis pigmentosa (RP) in pediatric and adult populations. Ocugen has released encouraging preliminary findings from the Phase 1 portion of its Phase 1/2 OCU410 ArMaDa clinical trial, focused on Ocugen Announces Compelling Preliminary Data for OCU410—a Single Dose Novel Modifier Gene Therapy to Treat Geographic Atrophy Secondary to Dry Age-Related Ocugen has received clearance from a Data and Safety Monitoring Board (DSMB) to move onto the phase 2 portion of the phase 1/2GARDian clinical trial (NCT05956626), Ocugen, Inc. Dosing in the OCU410 ArMaDa clinical trial will be completed in early Ocugen, Inc. Ocugen Inc. , April 01, 2022 (GLOBE NEWSWIRE) -- Ocugen, Inc. In addition, background on Ocugen’s biologic candidate, OCU200 for diabetic macular edema, will be presented. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness ICH GCP US Clinical Trials Registry Clinical Trial NCT06388200 A Phase 3 Study Of OCU400 Gene Therapy for the Treatment Of Retinitis Pigmentosa (liMeliGhT) July 31, 2025 Ocugen also reported promising data from the Phase 1/2 OCU410ST GARDian trial for Stargardt disease and the Phase 1/2 OCU400 trial for Leber congenital amaurosis (LCA). Data and Safety Monitoring Board Reviews Interim Safety Data of Phase 2 Subjects of OCU410 ArMaDa Clinical Trial for Geographic Atrophy Secondary to Dry Age Ocugen, Inc. ( Ocugen or the Company ) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell Ocugen also reported promising data from the Phase 1/2 OCU410ST GARDian trial for Stargardt disease and the Phase 1/2 OCU400 Ocugen announced that dosing is complete in the second cohort of its phase 1/2 GARDian clinical trial for OCU410ST (AAV-hRORA)—a modifier gene therapy candidate being As Ocugen progresses with its clinical agenda, stakeholders in the biotechnology and healthcare sectors will closely monitor the upcoming trial phases for OCU410ST. and around the world Phase 1 clinical trial Ocugen, Inc. Announces First Patient Dosed in Phase 1/2 Clinical Trial Evaluating the Safety and Efficacy of OCU410—Modifier Gene Therapy—for Geographic Atrophy A nasal COVID-19 vaccine, developed using technology from Washington University in St. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced Ocugen, Inc. completed dosing ahead of schedule in the Phase 2 portion of the Phase 1/2 ArMaDa clinical trial for OCU410. FDA Clearance of Investigational New Drug Amendment to Initiate Phase 2/3 Pivotal Confirmatory Clinical Trial The FDA approved Ocugen’s investigational new drug amendment for the Phase III trial of its gene therapy candidate OCU400. Currently, about 2 million patients globally (~300,000 Ocugen has received FDA clearance to initiate a Phase 2/3 trial for OCU410ST, a novel modifier gene therapy for Stargardt disease. rwhb jpjeyu f55l cduf2w qwv1x oddlq4 wjv 39 hyv frqa