06.18.2026

Ocular Therapeutix Aligns With FDA on Planned Axpaxli NDA Submission for Wet AMD

Key Takeaways Ocular Therapeutix has aligned with the FDA on a planned fourth-quarter 2026 NDA submission for Axpaxli in wet AMD based on SOL-1 efficacy and safety data plus interim SOL-R safety results The company is modifying the SOL-R trial to focus on long-term differentiation from aflibercept, including visual acuity superiority and retinal outcome assessments through Week 96 Ocular is also streamlining its diabetic retinopathy program, advancing a single global phase 3 study, HELIOS-3, evaluating once-yearly Axpaxli in non-proliferative diabetic retinopathy. Ocular Therapeutix announced that it has reached alignment with the FDA on plans to submit a new drug application (NDA) for Axpaxli (also known as OTX-TKI) for the treatment of wet age-related macular degeneration (AMD) in the fourth quarter of 2026.