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).
“The FDA’s clearance of FT-003 Phase 2 clinical trials for both nAMD and DME underscores the promising safety and preliminary efficacy demonstrated in Phase 1 trials conducted in China,” stated Dr. Xinyan Li, co-founder and CEO of Frontera Therapeutics. “FT-003 targets multiple ophthalmic indications by inhibiting VEGF activity, offering hope for patients suffering from these debilitating conditions. While DME presents unique challenges due to its complex pathogenesis and diverse clinical manifestations, this clearance marks a significant step forward in addressing this unmet medical need.”
Dr. Li continued: “Our Phase 1 clinical study conducted in China showcased FT-003’s ability to stably express the target protein in retinal cells via intravitreal injection. This led to a significant reduction in the treatment burden for patients with nAMD and DME by decreasing the annualized need for anti-VEGF therapy. FT-003’s safety profile and its potential to achieve long-term, effective treatment with a single dose provide a compelling solution for DME patients. The Phase 2 clearnace for DME reinforces our global development strategy and advances our mission to positively impact patients’ lives while creating value for our shareholders.”
Diabetic Macular Edema (DME)
DME is a prevalent microvascular complication of diabetes, affecting both Type 1 and Type 2 diabetes patients. Within 10 years of diagnosis, approximately 20% of Type 1 and 14%-25% of Type 2 diabetes patients develop DME, making it a leading cause of visual impairment and vision loss among middle-aged and elderly individuals.
About FT-003 Injection
FT-003 Injection is a recombinant adeno-associated virus (AAV) gene therapy product with a well-defined mechanism of action. Preclinical data demonstrate that FT-003 efficiently transfects retinal cells to express and secrete anti-VEGF protein, thereby inhibiting vascular endothelial cell proliferation, reducing vascular permeability, and delivering therapeutic benefits. A single intravitreal injection of FT-003 aims to provide long-term efficacy for patients with nAMD and DME, significantly reducing the need for frequent treatments.
FT-003 has successfully completed Phase 1 clinical trials for both nAMD and DME indications in China, and is currently enrolling subjects for Phase 2 trials. Phase 1 results revealed substantial improvements in visual acuity and retinal structure in patients, along with a greater than 80% reduction in the need for anti-VEGF therapy, drastically alleviating the treatment burden for patients.