Frontera Therapeutics’ FT-003 Achieves Regenerative Medicine Advanced Therapy Designation from the U.S. FDA for Neovascular Age-Related Macular Degeneration

Shanghai/Boston, July 29, 2026 — Frontera Therapeutics, a clinical-stage biotechnology company focused on innovative AAV gene therapies, announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its core product FT-003 for the treatment of neovascular age-related macular degeneration (nAMD). FT-003 is the first gene therapy product in China to receive RMAT designation for the (nAMD) indication.

Originating from the U.S. 21st Century Cures Act, the RMAT program is designed to expedite the development and regulatory review of advanced therapeutics, including gene therapies, which intend to treat, modify, reverse, or cure a serious or life-threatening disease or condition. This legislation was enacted with a core objective: to create an exclusive expedited review pathway for regenerative medicine products. Unlike the pre-existing Fast Track Designation and Breakthrough Therapy Designation, RMAT grants the eligibility to maintain close dialogues with the FDA on FT-003’s late-stage clinical development strategy, greatly accelerating the product’s overall clinical advancement timeline. The RMAT enables Frontera Therapeutics to engage in frequent, in-depth communications with the FDA regarding the late-stage clinical development plan of FT-003.

Dr. Xinyan Li, Chief Executive Officer and Chief Medical Officer of Frontera Therapeutics, stated: “The RMAT designation granted to FT-003 for nAMD is supported by FT-003‘s robust Phase II clinical data generated in China. Phase II clinical readouts show that FT-003 improves visual acuity, resolves retinal edema and restores retinal architecture. In addition, FT-003 significantly reduces the treatment burden of repeated anti-VEGF injections for patients. With a favorable safety and tolerability profile, FT-003 stands out as a highly competitive AAV gene therapy candidate.” Dr. Li added, “This RMAT designation marks a pivotal milestone in FT-003’s development journey. Leveraging this accelerated pathway, we will further advance the global clinical development of FT-003, striving to deliver this transformative therapeutic option to nAMD patients worldwide in the near future.”

About nAMD

nAMD is a progressive retinal degenerative disease driven by vascular endothelial growth factor (VEGF). It is characterized by abnormal choroidal neovascularization in the macula, which leads to fluid leaks and/or blood, resulting in macular edema, hemorrhage, scarring, and potentially irreversible central vision loss. Currently, the standard of care for nAMD relies on repeated intravitreal anti-VEGF injections, imposing a substantial treatment burden on patients. nAMD is one of the leading causes of blindness in the population aged 65 and above. According to Frost & Sullivan, the global prevalence of nAMD exceeded 20 million in 2025, and the patient population is projected to surpass 25 million by 2035.

About FT-003

FT-003 is an investigational intravitreal AAV gene therapy encoding aflibercept, designed to provide sustained intraocular anti-VEGF expression following a single injection. FT-003 enables patients to sustain visual acuity benefits while substantially reducing their treatment burden from repeated injections.

About Frontera Therapeutics
Frontera Therapeutics is a clinical-stage biotech company focused on the discovery, development, and production of adeno-associated virus (AAV)-based gene therapies for ocular diseases and cardiovascular diseases. Leveraging its proprietary AAVANCE™ baculovirus/Sf9 manufacturing platform, EXACTE™ early-stage discovery platform and a portfolio of engineered AAV capsids with optimized retinal tropism, Frontera Therapeutics is building a pipeline of transformative treatments for both inherited retinal disorders and neovascular conditions with significant unmet medical need in ophthalmology. The Company operates across China and U.S. with global footprints and maintains active collaborations with leading academic medical centers.

Disclaimers

1. This article is intended solely for the dissemination of research progress and is not for advertising purposes.

2. The products mentioned in this article have not yet been approved for marketing in China.

3. The content of this article shall not replace professional medical guidance in any form and shall not be regarded as medical diagnosis or treatment advice.

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