Shares of Ocular Therapeutix (NASDAQ:OCUL) fell about 1% on Wednesday after the company used its Investor Day to lay out a revised regulatory and trial timeline for its lead candidate, AXPAXLI, in wet age-related macular degeneration.
The Bedford, Massachusetts-based biopharmaceutical firm said it reached agreement with the U.S. Food and Drug Administration at a Type C meeting in May 2026 on the data package the agency will accept for a New Drug Application. Specifically, Ocular said the planned NDA will be based on SOL-1 Week 52 efficacy and safety results together with interim safety data from its SOL-R study.
As part of that plan, the company intends to perform an interim safety analysis of SOL-R in the fourth quarter of 2026 to ensure the combined safety database from SOL-1 and SOL-R exceeds 300 patients, in keeping with FDA expectations. Ocular emphasized that SOL-R efficacy outcomes will not be included in the AXPAXLI NDA submission.
The company will still collect SOL-R efficacy information, but it is now positioning superiority of AXPAXLI against aflibercept (8 mg) administered every six months at Week 96 as a key secondary endpoint of the SOL-R trial. SOL-R will remain masked through Week 96, and topline efficacy results from that trial are now slated for the first quarter of 2028, a later timing than previously communicated.
Ocular indicated it plans to file the NDA under the 505(b)(2) regulatory pathway, which the company said could shorten the review period by up to 60 days. Separately, the company is narrowing its diabetic retinopathy program to prioritize HELIOS-3 as a potential single registrational trial to evaluate AXPAXLI dosed every 12 months.
Background on the clinical program included a reminder that the SOL-1 trial completed randomization of 344 treatment-naive subjects with wet AMD in December 2024. In February 2026, Ocular reported that 74.1% of subjects in the AXPAXLI arm maintained vision at Week 36 compared with the aflibercept arm, meeting the trial’s superiority primary endpoint with a p-value of 0.0006.
The aggregate of these decisions - basing the NDA on SOL-1 Week 52 plus interim SOL-R safety, removing SOL-R efficacy from the submission, and extending SOL-R topline timing - informed investors and coincided with a modest share price decline following the company’s Investor Day.
Regulatory and trial timeline at a glance
- May 2026 Type C meeting with FDA - alignment to base NDA on SOL-1 Week 52 plus interim SOL-R safety data.
- Q4 2026 - planned interim SOL-R safety analysis to reach more than 300 patients of combined safety data.
- Q4 2026 - target window for submitting the AXPAXLI NDA under the 505(b)(2) pathway.
- Week 96 of SOL-R - superiority versus aflibercept (8 mg) every six months to be assessed as a key secondary endpoint; SOL-R remains masked through Week 96.
- Q1 2028 - expected topline SOL-R efficacy results.
These updates reflect a focused regulatory filing strategy while deferring a separate SOL-R efficacy readout to support longer-term comparative assessment.