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 […]
Read MoreExpanded 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. Find information on currently enrolling clinical trials for Frontera’s investigational therapies on clinicaltrials.gov. Frontera reserves the […]
Read MoreFDA 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 […]
Read More2024 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”. […]
Read MoreFrontera Therapeutics’s Quality Control for rAAV Gene Therapy Products Presented at the 23rd China Biological Products Annual Conference 2024
May 16-18, 2024— the 23rd China Biological Products Annual Conference was held in Guangzhou, China. Dr. Li Aiqun, Director of QC, Frontera Therapeutics, was invited to participate in the symposium of “Immune Cells, Stem Cells and Gene Therapy” and focused on “Quality Control of rAAV Gene Therapy Products: Challenges of Next Generation Sequencing and Residual DNA […]
Read MoreFrontera Therapeutics Unveils Preliminary Clinical Results for FT-002 Injection at Retinal Cell and Gene Therapy Innovation Summit 2024
May 6, 2024–Frontera Therapeutics is pleased to announce significant advancements in our clinical study of FT-002, presented at Retinal Cell and Gene Therapy Innovation Summitin the United States on May 3, 2024. Professor Sui Ruifang, from Peking Union Medical College Hospital, was invited to present the clinical results, titled “Preliminary safety and efficacy of an […]
Read MoreFrontera Therapeutics to Showcase at the International Conferences in May 2024
Boston, MA, USA – April 22, 2024. Frontera Therapeutics is excited to announce its participation in several esteemed conferences in May 2024, where it will present groundbreaking research across multiple therapeutic areas, including ophthalmology, blood and cardiovascular diseases. The conferences are the 2024 Retinal Cell and Gene Therapy Innovation Summit, the 2024 American Ophthalmology Congress, […]
Read MoreFrontera’s “Innovative Solutions of rAAV Purification Process” Unveiled at the 7th Gene Therapy for Rare Disorder 2024
Boston, MA, USA – April 1, 2024. The 7th Gene Therapy for Rare Disorder 2024 took place in Boston, MA from March 26 to 29, 2024. Dr. Hongxiang Lu, Senior Vice President of Frontera Therapeutics, was invited to participate in the panel discussion on “Gene Drug Manufacturing” and gave a keynote presentation on “Case Studies […]
Read MoreFrontera’s Study Report on ” Case Studies of Resolving rAAV Aggregation & Removing Empty Vectors ” will be presented in Gene Therapy for Rare Disorders 2024
Boston, USA – March 18, 2024 – Frontera Therapeutics, a leading biotechnology company committed to advancing gene therapy drugs to address unmet medical needs worldwide, is delighted to announce its participation in the upcoming 7th Gene Therapy for Rare Disorders 2024 Conference in Boston, USA. Dr. Robert Lu, Senior Vice President of Frontera, has been […]
Read MoreFrontera Therapeutics’ FT-002 Achieves Orphan Drug Designation from the U.S. FDA for Inherited Retinal Dystrophies
BEDFORD, Mass., and Suzhou, China, January 23, 2024 — Frontera Therapeutics announces that its pioneering AAV gene therapy product, FT-002, has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of Inherited Retinal Dystrophies (IRD) caused by RPGR gene variants. About Orphan Drug Designation Orphan Drug Designation, granted […]
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