May 7, 2026

Frontera Therapeutics Presents Positive Top-Line Phase II Data for FT-002 and FT-003 at ARVO 2026

FT-002 Demonstrates Sustained Vision Improvements in Pediatric XLRP Participants; FT-003 Shows Durable Visual Gains with Substantially Reduced Injection Burden in nAMD

SHANGHAI and DENVER, May 7, 2026 — Frontera Therapeutics, a clinical-stage company developing adeno-associated virus (AAV) gene therapies for retinal diseases, today announced positive top-line Phase II data for two lead investigational programs, FT-002 for RPGR-associated X-linked retinitis pigmentosa (XLRP) and FT-003 for neovascular age-related macular degeneration (nAMD), presented at the 2026 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) in Denver U.S.

The data highlight continued clinical progress across Frontera Therapeutics' ophthalmology pipeline and further support the Company's proprietary AAVANCE™ baculovirus/Sf9 manufacturing platform for retinal gene therapies.

FT-002 for RPGR-Associated XLRP: Preliminary Phase II 9-Month Results

Presenter:
Ruifang Sui, MD, PhD
Peking Union Medical College Hospital, Beijing, China

FT-002 is an investigational subretinal AAV5 gene therapy designed to deliver a codon-optimized full-length RPGR ORF15 transgene following a single administration.

In the ongoing Phase II study, FT-002 demonstrated a favorable safety profile in pediatric participants through nine months of follow-up, with no serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), or treatment-related ocular inflammation reported.

Key efficacy observations included:
• Sustained improvements in low-luminance visual acuity (LLVA), with 50% of participants achieving gains of at least ten letters;
• Sustained improvements in best-corrected visual acuity (BCVA);
• Stable-to-improved retinal sensitivity over the follow-up period in study eyes, while fellow eyes showed no corresponding gains.

"These early data suggest FT-002 may provide meaningful and durable improvements in visual function following a single administration in pediatric participants with RPGR-associated XLRP," said Ruifang Sui, principal investigator at Peking Union Medical College Hospital.

The overall benefit-risk profile supports continued development of FT-002. Additional data from pediatric and adult cohorts are expected in 2026.

FT-003 for nAMD: Interim Phase II 28-Week Results

Presenter:
Xiaorong Li, MD,PhD
Tianjin Medical University Eye Hospital, Tianjin, China

FT-003 is an investigational intravitreal AAV gene therapy encoding aflibercept, designed to provide sustained intraocular anti-VEGF expression following a single injection.

The Phase II study evaluated two FT-003 dose levels versus aflibercept 2 mg administered every eight weeks in participants with neovascular age-related macular degeneration.

In the interim analysis, FT-003 demonstrated visual acuity gains at Week 28 comparable to aflibercept control treatment, while substantially reducing treatment burden.

Key findings included:
• Mean BCVA improvements at Week 28 comparable to aflibercept 2 mg Q8W;
• More than 90% reduction in annualized anti-VEGF injection burden versus control;
• 85.0% and 78.9% of participants in the two FT-003 dose groups, respectively, required no supplemental aflibercept injections through Week 28;
• No reported cases of infectious endophthalmitis, retinal vasculitis, vascular occlusion, or FT-003-related serious adverse events.

"The interim Phase II findings support the potential of FT-003 to maintain vision outcomes while substantially reducing injection burden in nAMD," said Xiaorong Li, principal investigator at Tianjin Medical University Eye Hospital.

The overall benefit-risk profile supports advancement of FT-003 into Phase III development for nAMD.

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.

Statements

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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