Ocugen
Ocugen is a fully integrated, patient-centric biotech company focused on vaccines, gene, and cell therapies targeting unmet medical needs through courageous innovation. They discover, develop, and commercialize novel therapies to improve health and offer hope for patients worldwide, with a mission driven by bold and innovative approaches to medicine.
Industries
Nr. of Employees
medium (51-250)
Products
Modifier gene therapy candidate for retinitis pigmentosa (AAV-based regulator)
AAV-delivered modifier gene therapy in clinical development for retinitis pigmentosa and related retinal degenerations; being evaluated in a Phase 3 multicenter randomized assessor-blinded study.
Modifier gene therapy candidate for geographic atrophy / Stargardt disease (AAV-hRORA)
AAV-based modifier gene therapy under Phase 1/2 evaluation for geographic atrophy secondary to dry AMD and for Stargardt disease in separate studies; product concept based on expression of a regulatory transcription factor.
Autologous tissue-engineered cartilage implant (3D neocartilage)
A patient-derived, 3D tissue-engineered cartilage implant manufactured from autologous chondrocytes on a collagen scaffold, intended for implantation to repair articular cartilage lesions of the knee.
Preclinical mucosal/inhaled vaccine candidates (COVID-19 and influenza)
Preclinical inhalation/intranasal vaccine candidates aimed at mucosal immunity for respiratory pathogens, pursued as part of an inhaled vaccine platform; includes separate preclinical candidates for COVID-19, influenza, and combination products.
Expanded access availability of inactivated whole-virus vaccine under EAP
Provision of an inactivated whole-virus COVID-19 vaccine to eligible US patients under an expanded access framework, including application and site requirements and IND support.
Modifier gene therapy candidate for retinitis pigmentosa (AAV-based regulator)
AAV-delivered modifier gene therapy in clinical development for retinitis pigmentosa and related retinal degenerations; being evaluated in a Phase 3 multicenter randomized assessor-blinded study.
Modifier gene therapy candidate for geographic atrophy / Stargardt disease (AAV-hRORA)
AAV-based modifier gene therapy under Phase 1/2 evaluation for geographic atrophy secondary to dry AMD and for Stargardt disease in separate studies; product concept based on expression of a regulatory transcription factor.
Autologous tissue-engineered cartilage implant (3D neocartilage)
A patient-derived, 3D tissue-engineered cartilage implant manufactured from autologous chondrocytes on a collagen scaffold, intended for implantation to repair articular cartilage lesions of the knee.
Preclinical mucosal/inhaled vaccine candidates (COVID-19 and influenza)
Preclinical inhalation/intranasal vaccine candidates aimed at mucosal immunity for respiratory pathogens, pursued as part of an inhaled vaccine platform; includes separate preclinical candidates for COVID-19, influenza, and combination products.
Expanded access availability of inactivated whole-virus vaccine under EAP
Provision of an inactivated whole-virus COVID-19 vaccine to eligible US patients under an expanded access framework, including application and site requirements and IND support.
Services
Expanded Access Program management
Evaluation and administration of written requests for individual patient access, coordination with treating physicians, support for IND submissions and IRB approvals, and collection of clinical data under EAP protocols.
Partnering and business development
Collaborative partnerships for R&D, manufacturing and commercialization across vaccines, gene therapies and regenerative cell therapies; business development contact and alliance management.
Clinical trial conduct and support
Design and operational execution of multicenter clinical trials including patient recruitment, assessor-blinded randomized study execution and clinical oversight for ophthalmic and vaccine studies.
cGMP manufacturing and supply capabilities
Clinical and commercial manufacturing capabilities for gene, cell and vaccine products with facility operations planned or in place to support domestic supply and scale-up.
Expanded Access Program management
Evaluation and administration of written requests for individual patient access, coordination with treating physicians, support for IND submissions and IRB approvals, and collection of clinical data under EAP protocols.
Partnering and business development
Collaborative partnerships for R&D, manufacturing and commercialization across vaccines, gene therapies and regenerative cell therapies; business development contact and alliance management.
Clinical trial conduct and support
Design and operational execution of multicenter clinical trials including patient recruitment, assessor-blinded randomized study execution and clinical oversight for ophthalmic and vaccine studies.
cGMP manufacturing and supply capabilities
Clinical and commercial manufacturing capabilities for gene, cell and vaccine products with facility operations planned or in place to support domestic supply and scale-up.
Expertise Areas
- Modifier gene therapy
- AAV vector gene therapy
- Regenerative cell therapy and tissue engineering
- Mucosal/inhaled vaccine development
Key Technologies
- Adeno-associated virus (AAV) vectors
- Modifier gene regulation approach
- 3D tissue-engineered autologous cartilage constructs
- Bioreactor cell differentiation systems