Ocugen
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2013-01-01
- Employees
- 65
- Market Cap
- $382.8M
- Website
- http://www.ocugen.com
- Introduction
Ocugen, Inc. is a biopharmaceutical company, which engages in the development and commercialization of therapies to cure eye diseases. Its product pipeline candidates include OCU400, OCU410, OCU200, and COVAXIN. The firm's modifier gene therapy platform is engaged in addressing retinal diseases, including retinitis pigmentosa, leber congenital amaurosis, and dry age-related macular degeneration. The company was founded by Shankar Musunuri and Uday B. Kompella in 2013 and is headquartered in Malvern, PA.
Ocugen, Inc. Receives Orphan Medicinal Product Designation From EMA For OCU410ST In ...
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Ocugen Announces European Medicines Agency Grants Orphan
Ocugen, Inc. announced the EMA granted orphan medicinal product designation for OCU410ST, a treatment for ABCA4-associated retinopathies including Stargardt disease, RP19, and CORD3. The FDA previously granted orphan drug designation in April 2023. OCU410ST, utilizing an AAV delivery platform, aims to treat these diseases with a one-time therapy.
Ocugen Receives Orphan Medicinal Product Designation From EMA For OCU410ST
Ocugen, Inc. announced the European Medicines Agency granted orphan medicinal product designation for OCU410ST for ABCA4-associated retinopathies, including Stargardt disease. The FDA previously granted orphan drug designation in April 2023. Ocugen plans to pursue an accelerated marketing authorization application.
Ocugen's Eye Disease Drug Shows 84% Lesion Reduction, Receives EMA Orphan Status
EMA grants orphan medicinal product designation to Ocugen's OCU410ST for treating ABCA4-associated retinopathies, including Stargardt disease, offering benefits like 10 years of market exclusivity. Phase 1/2 GARDian trial data shows an 84% reduction in atrophic lesion growth in treated eyes. The treatment targets 100,000 patients in the U.S. and Europe.
Scaling Gene Therapy Clinical Trials Through The Lens Of Ophthalmology
Scaling gene therapy trials for rare diseases involves addressing patient heterogeneity, leveraging specialized surgeons and centers, selecting appropriate trial sites, managing logistical and manufacturing challenges, ensuring consistent patient care, and forming strategic partnerships. Success requires a blend of scientific insight, logistical strategy, and robust partnerships.
How a gene-agnostic approach opens doors to new therapeutics
Dr. Arun Upadhyay discusses Ocugen's OCU400, a gene-agnostic therapy for retinitis pigmentosa and Leber congenital amaurosis, highlighting its Phase I/II safety and efficacy, leading to a Phase III study with 150 patients. He emphasizes the gene-agnostic approach's potential to benefit a broader group of patients, irrespective of genetic backgrounds, and mentions regulatory milestones including FDA and EMA approvals.
Ocugen Provides Business Update with Third Quarter 2024 Financial Results
Ocugen reports Q3 2024 financials, including $30M debt financing, and updates on OCU400 Phase 3 liMeliGhT trial for RP, OCU410 Phase 2 ArMaDa trial for GA, and OCU410ST Phase 1/2 GARDian trial. Cash runway extended to 1Q2026.
Earnings call: Ocugen outlines progress in ophthalmology trials, financials
Ocugen reported Q3 financial results and clinical updates, highlighting Health Canada approval for OCU400 Phase 3 trial and U.S. FDA's Expanded Access Program. The company initiated a Phase 1 trial for OCU200 targeting Diabetic Macular Edema and secured $30 million in debt financing, extending financial runway to Q1 2026. Key milestones include OCU400 trial enrollment completion expected in H1 2025, BLA/MAA filings in H1 2026, and commercialization plans for 2027.
Ocugen Inc. filed SEC Form 8-K: Entry into a Material Definitive Agreement, Creation of a ...
Ocugen, Inc. entered into a Loan and Security Agreement with Avenue Capital Management II, L.P. for up to $30 million, maturing Nov 1, 2028, with variable interest and a final payment of 4.25% of the Loan Amount. The agreement includes a prepayment fee and conversion rights for the lenders. Additionally, Ocugen issued shares of Common Stock to the lenders under a Subscription Agreement, relying on exemptions from registration under the Securities Act of 1933.
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