Ocular Therapeutix Inc. (NASDAQ:OCUL) shares are up on Monday following the announcement of additional positive data from the SOL-1 Phase 3 trial of Axpaxli, its investigational treatment for wet age-related macular degeneration (AMD).

The company focuses on developing and commercializing product candidates for retinal diseases.

In February, data from the SOL-1 Phase 3 superiority trial fell short of investor expectations.

The study showed that 74.1% of subjects treated with Axpaxli maintained vision at Week 36, compared to 65.9% in the aflibercept arm, marking a notable risk difference of 17.5%.

The company is on track to submit a New Drug Application, aligning with recent FDA commentary on approval processes.

Axpaxli Shows Durable Efficacy Across Key Endpoints

The investigational delivered a strong efficacy profile, achieving statistical significance in the first three of five key secondary endpoints tested hierarchically, while also meeting six additional pre-specified endpoints tied to clinically meaningful functional and anatomical outcomes.

The data underscores both the consistency and breadth of the treatment's effect, reinforcing its positioning against Regeneron Pharmaceutical Inc.’s (NASDAQ:REGN) Eylea (aflibercept 2 mg) across multiple measures of disease progression and patient outcomes.

Lower Risk Of Anatomic Worsening

Post-hoc analysis highlighted sustained disease control, with patients treated with Axpaxli showing a significantly lower risk of anatomic worsening beginning at Week 8 versus those receiving aflibercept.

The median time to a ≥30 µm increase in Central Subfield Thickness (CSFT) was 39 weeks for Axpaxli compared to 16 weeks for aflibercept, marking a 23-week difference.

A hazard ratio of 0.7 suggests a 30% lower risk of worsening between Weeks 8 and 52.

For more severe progression (≥75 µm CSFT increase), the median time was 46 weeks versus 24 weeks, respectively. The hazard ratio of 0.5 indicates a 50% reduction in risk for Axpaxli-treated patients.

Vision Gains Sustained Through One Year

Visual acuity improvements achieved during the loading phase were largely maintained through Week 52 across baseline vision subgroups.

Patients with the lowest baseline vision derived the greatest benefit, gaining +11.8 ETDRS letters compared to +8.5 letters in the aflibercept arm.

Meanwhile, those with near-normal baseline vision saw minimal change.

Consistent Outcomes In Rescue-Free Patients

Among patients who did not require rescue therapy, Axpaxli continued to demonstrate stable outcomes.

At Week 24, 81% of patients remained rescue-free, with vision gains of +7.5 letters from screening.

By Week 36, 75% of patients were still rescue-free, maintaining most of their earlier gains with minimal decline.

OCUL Price Action: Ocular Therapeutix shares were up 0.63% at $8.84 at the time of publication on Monday, according to Benzinga Pro data.

Image via Shutterstock