Ocular Therapeutix to File AXPAXLI Wet AMD NDA in Q4 2026 With Interim Safety Data
OCUL•Ocular Therapeutix secured FDA agreement to submit a 505(b)(2) NDA for AXPAXLI in wet AMD in 4Q2026, relying on SOL-1 Week 52 efficacy/safety and interim SOL-R safety data from over 300 patients. SOL-R efficacy is deferred, with top-line results on a superiority endpoint versus aflibercept expected in 1Q2028.
1. FDA Alignment and NDA Timeline
Following a May Type C meeting, Ocular Therapeutix finalized U.S. FDA alignment to submit its AXPAXLI NDA for wet AMD in the fourth quarter of 2026, based on SOL-1 Week 52 efficacy and safety data alongside interim SOL-R safety results.
2. SOL-1 and SOL-R Trial Adjustments
SOL-1 demonstrated robust Week 52 durability and safety, enabling removal of SOL-R efficacy from the submission. SOL-R will maintain masking through Week 96, targeting a key secondary endpoint of superiority in best-corrected visual acuity versus aflibercept 8 mg Q6M, with topline results now slated for 1Q 2028.
3. 505(b)(2) Pathway and Review Acceleration
Ocular plans to leverage the 505(b)(2) regulatory pathway for AXPAXLI, potentially accelerating FDA review by up to 60 days and reducing reliance on full clinical datasets through reliance on prior aflibercept safety and efficacy data.
4. Diabetic Retinopathy Program Streamlining
The company is streamlining its diabetic retinopathy development to a single Phase 3 registrational trial, HELIOS-3, evaluating once‐yearly AXPAXLI dosing versus sham to meet market demand for a Q12M regimen and support global adoption.
