Overview
- Ocular said it will submit a New Drug Application for AXPAXLI in the fourth quarter of 2026 relying on SOL‑1 Week 52 efficacy and safety data plus interim safety from the ongoing SOL‑R study.
- SOL‑1 produced statistically significant results versus aflibercept on vision‑maintenance endpoints at Week 36 and Week 52, and the company plans to use those data as the core evidence for the filing.
- The company told regulators it will file under the 505(b)(2) pathway, which lets a sponsor rely in part on existing literature or prior approvals and can shorten the FDA review clock by about 60 days.
- Ocular redesigned SOL‑R so efficacy will not be included in the NDA, extended masking through Week 96, set an interim safety analysis to reach more than 300 pooled patients in the fourth quarter of 2026, and now expects SOL‑R topline in Q1 2028.
- The firm consolidated its diabetic retinopathy program to prioritize the HELIOS‑3 registrational trial and is adding a SOL‑R secondary endpoint to compare AXPAXLI against aflibercept at Week 96 to support possible label differentiation and broader adoption if approved.