Eyewire+Ocular Therapeutix Aligns with FDA on Planned Axpaxli NDA Submission for Wet AMD

📋 Regulatory Action / Label Change

Ocular Therapeutix has reached agreement with the FDA on the submission pathway for Axpaxli (OTX-TKI), a sustained-release intravitreal tyrosine kinase inhibitor. The NDA will pursue the 505(b)(2) pathway and is expected to include a combined safety database exceeding 300 patients with at least one year of treatment exposure from SOL-1 and SOL-R.

Drug Status:
Axpaxli is not yet approved. SOL-1 met its primary endpoint demonstrating superiority on maintenance of vision at Week 36 (P=.0006) under a Special Protocol Assessment agreement. NDA submission is targeted for Q4 2026; commercial availability, if approved, is projected for 2027. A separate phase 3 study, HELIOS-3, will evaluate once-yearly Axpaxli in non-proliferative diabetic retinopathy with a primary endpoint at Week 56.

What Changes / What Stays the Same:

• SOL-R is being modified to extend masking through Week 96 and add superiority endpoints versus aflibercept 8 mg, with topline results now expected Q1 2028
• Anti-VEGF agents remain the current standard of care for wet AMD; Axpaxli’s once-yearly dosing interval is the primary differentiation claim under investigation
• Diabetic retinopathy program consolidated to a single global registrational trial (HELIOS-3), narrowing the development footprint

Watch For:

• FDA acceptance and review timeline following Q4 2026 NDA submission
• SOL-R Week 96 data on visual acuity superiority and fibrosis/atrophy outcomes versus aflibercept
• HELIOS-3 enrollment progress and Week 56 primary endpoint results for non-proliferative diabetic retinopathy