Frontera Therapeutics Receives FDA Clearance to Initiate Phase II Clinical Trials for AAV Gene Therapy FT-003 in Diabetic Macular Edema and nAMD
Frontera Therapeutics
Innovative Gene Therapy Drug R&D and Producer
On December 25, 2024, Frontera Therapeutics announced that its self-developed innovative AAV gene therapy product, FT-003 Injection, received approval for its second indication—treating diabetic macular edema.（Diabetic Macular Edema，DME）Obtained the approval from the U.S. Food and Drug Administration（FDA）Approval for Direct Initiation of Phase II Clinical Study.FT-003 Received FDA Approval in November 2024 to Initiate Treatment for Neovascular Age-Related Macular Degeneration（nAMD）Phase II Clinical Trial.
"The FDA approval for Frontera Therapeutics' FT-003 in Phase II clinical trials for nAMD and DME is based on the Phase I clinical data conducted in China. The preliminary results demonstrated good safety and initial efficacy of FT-003 across multiple targeted anti-VEGF ophthalmic indications, laying the groundwork for FT-003 to expand into more anti-VEGF ophthalmic indications."Dr. Xinyan Li, Co-founder and CEO of Frontera Therapeutics, introduced"FT-003 treating DME carries significant risks and challenges. Due to the complex pathogenesis of DME and diverse clinical pathological manifestations, only three AAV products globally have entered clinical trials for DME patients so far, with no clinical trial results officially announced yet."
Dr. Li Xinyan added: "The results of our Phase I clinical trials conducted in China show that FT-003 injection, administered through intravitreal injection, can stably express the target protein in retinal cells. It significantly reduces the annual treatment burden of anti-VEGF drugs for patients with nAMD and DME, while demonstrating good safety. It is expected to achieve the goal of long-term efficacy with a single administration, meeting the clinical treatment needs of DME patients. The approval of FT-003 DME Phase II clinical trials will support our global development strategy and speed, positively impacting patients with nAMD and DME, while also creating value for our shareholders."
Diabetic Retinopathy（Diabetic Retinopathy，DR）Is a diabetic patient(Including Type I and Type II)One of the most common microvascular complications, 20% of Type 1 diabetes and 14%-25% of Type 2 diabetes patients will develop DME within 10 years. DME is the leading cause of vision impairment and vision loss in middle-aged and elderly patients.
FT-003 Injection, as a novel recombinant adeno-associated virus gene therapy product, has a very clear mechanism of action: preclinical data show that after FT-003 is injected into the fundus, it can efficiently transfect multi-layer retinal cells, enabling them to express and secrete anti-VEGF proteins, inhibit vascular endothelial cell division and proliferation, reduce vascular permeability, and generate comprehensive therapeutic effects. It is expected that a single injection will treat nAMD and DME patients with long-term efficacy.
In China, FT-003 Injection has been approved for nAMD and diabetic macular edema.（DME）Clinical approvals for two indications have completed Phase I clinical studies and entered the subject enrollment phase of Phase II clinical trials. The Phase I clinical study results of FT-003 showed that after nAMD and DME patients received intravitreal injections of FT-003, both vision and retinal structure significantly improved. Moreover, the need for anti-VEGF treatment decreased by over 80%, greatly reducing the treatment burden for nAMD and DME patients.
●Share the vast resources of the new drug ecosystem;
●Exclusive discount for Tongxiyi events;
●Membership-exclusive seating and expert interaction opportunities;
●Priority sponsorship rights for Tongxiyi events;
● Institutional brand event planning and comprehensive promotion;
●One-on-one attentive service from the Secretariat.
