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).

FT-003 Injection: A Promising Gene Therapy for Retinal Diseases

FT-003 has demonstrated significant therapeutic benefits in clinical trials for nAMD and DME, reinforcing its potential for DR treatment.

Proven Efficacy – Patients treated with FT-003 Injection showed significant improvements in visual acuity and retinal structure, with a substantial reduction in the need for anti-VEGF rescue therapy. Among patients monitored for up to two years, no additional anti-VEGF treatments were required, significantly reducing the treatment burden.

Strong Safety Profile – FT-003 has exhibited high safety and tolerability, driven by Frontera’s innovative vector optimization platform and advanced manufacturing processes.

Expanding Global Reach and Therapeutic Potential

FT-003 has already been cleared for Phase II clinical trials in both China and the United States for nAMD and DME, with patient recruitment underway at multiple hospitals.

The latest IND clearance for DR represents a strategic milestone in Frontera’s commitment to tackling ocular fundus diseases. DR is one of the leading causes of vision impairment and blindness worldwide, affecting 30–35% of diabetic patients, with approximately 10% developing vision-threatening complications. In China alone, an estimated 19.5 million diabetic patients suffer from DR.

While current treatments—including laser therapy, anti-VEGF drugs, and vitrectomy—can help manage DR, early intervention is critical to preventing vision loss. Anti-VEGF therapies are particularly effective in maintaining retinal structure, preventing neovascularization, and offering disease control across all DR stages. However, its effectiveness depends on frequent injections, leading to challenges in patient compliance and treatment burden.

FT-003 aims to overcome these challenges by offering a one-time gene therapy injection with long-lasting therapeutic benefits. Delivered via intravitreal injection, FT-003 has demonstrated high delivery efficiency and durable efficacy.

Frontera remains committed to advancing next-generation gene therapies and exploring FT-003’s potential for additional ophthalmic indications, delivering innovative and long-lasting treatment solutions for patients worldwide.