Ocular Therapeutix Inc. (NASDAQ: OCUL) shares surged over 5% in pre-market trading on Tuesday after the company provided key updates regarding its pivotal trials for AXPAXLI, its leading drug candidate for treating wet age-related macular degeneration (wet AMD).

The company announced that the U.S. Food and Drug Administration (FDA) has approved an amendment to the special protocol assessment (SPA) for its Phase 3 SOL-1 trial. This amendment allows for redosing of AXPAXLI at weeks 52 and 76 in addition to the initial 36-week primary endpoint.

By incorporating redosing, Ocular Therapeutix aims to collect valuable data on the potential dosing flexibility and durability of AXPAXLI. This could position the company to secure a differentiated product label with dosing intervals ranging from 6 to 12 months, if the trial is successful. Such a broad dosing window would be unprecedented in the wet AMD market and could significantly reduce treatment burden for patients compared to currently available therapies.

Additionally, Ocular Therapeutix has streamlined its SOL-R trial, another key study evaluating AXPAXLI in a repeat dosing setting. The company has reduced the target enrollment for this trial from 825 to approximately 555 patients while maintaining robust 90% statistical power. This adjustment, enabled by the redosing introduced in SOL-1, is expected to enhance capital efficiency and potentially accelerate the timeline for completing SOL-R.

Impressively, enrollment continues to progress well across both pivotal trials. Ocular Therapeutix has already completed randomization for the SOL-1 trial, enrolling 344 patients across over 100 clinical sites in the U.S. and Argentina. Additionally, as of January 10, 2025, the company had enrolled 311 patients in various stages of the SOL-R trial.