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Company News

Year: All 2025 2024 2023 2022

Frontera Therapeutics Announces IND Clearance for FT-003 in Diabetic Retinopathy

March 13, 2025 – Frontera Therapeutics announced today that its proprietary recombinant adeno-associated virus (rAAV) gene therapy, FT-003 Injection, has received Investigational New Drug (IND) clearance from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of Diabetic Retinopathy (DR). This marks the third cleared indication for FT-003, following its previous clearances for neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME).
2025-03-13
Frontera Therapeutics Receives FDA Clearance for Phase 2 Clinical Trial of FT-003 for Diabetic Macular Edema (DME)

Boston, MA, November 25, 2024 – Frontera Therapeutics is pleased to announce that the U.S. Food and Drug Administration (FDA) has cleared its AAV gene therapy product, FT-003 Injection, for a Phase 2 clinical trial targeting Diabetic Macular Edema (DME). This milestone follows the FDA’s prior clearance for FT-003 to conduct a Phase 2 trial for neovascular age-related macular degeneration (nAMD).
2024-12-30
FDA Frontera Receives FDA clearance for FT-003 Phase 2 IND in Neovascular Age-Related Macular Degeneration

Boston, MA, November 11, 2024 –Frontera is pleased to announce that the U.S. Food and Drug Administration (FDA) has cleared its Phase 2 Investigational New Drug (IND) application for FT-003 Injection, an innovative recombinant adeno-associated virus (rAAV) gene therapy product, for the treatment of neovascular age-related macular degeneration (nAMD). This clearance reflects the FDA’s recognition of Frontera’s early clinical and Chemistry, Manufacturing, and Controls (CMC) data from clinical trials conducted in China, marking a pivotal step in Frontera’s efforts to bring advanced gene therapies for chronic diseases to the US market.
2024-11-12
Expanded Access Policy

We are committed to developing high quality and affordable gene therapies as quickly as possible. Currently, Access to our investigational medicines is only through participation in clinical trials. Frontera is not able to offer expanded access to its investigational medicines.
2024-10-22
FDA Clears Frontera’s FT-002 for Phase II Clinical Trials in the U.S.

Boston, MA, September 23, 2024 – Frontera is excited to announce that its gene therapy product, FT-002, has been cleared by the U.S. Food and Drug Administration (FDA) for Phase II clinical trials in the U.S. This approval marks a major milestone, as FT-002 becomes the first recombinant adeno-associated virus (rAAV) gene therapy to receive FDA clearance for Phase II trials based on clinical data obtained from studies conducted in China.
2024-09-22
2024 Highlights of the 5th Gene Therapy for Ophthalmic Disorders Summit: Frontera’s AAV Capsids for Suprachoroidal Delivery

Sep 10-12, 2024— the 5th Annual Gene Therapy for Ophthalmic Disorders Summit was held in Boston, USA. Dr. Zhong-Dong Shi, Executive Director, head of R&D, Frontera Therapeutics, was invited to participate in discussion on “Optimizing Capsid Design & Vector Engineering for Ophthalmic Gene Therapy” and gave a keynote address on “Novel AAV Capsids for Suprachoroidal Delivery”.
2024-09-13

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