Ocular Therapeutix’s SOL-1 Data Showcases Unmatched Durability for AXPAXLI in Wet AMD—23 to 22-Week Advantage Over Standard Treatment

AXPAXLI Significantly Extends Disease Control Compared to Aflibercept

In its latest announcement, Ocular Therapeutix unveiled additional positive data from the SOL-1 Phase 3 trial of AXPAXLI (OTX-TKI), further strengthening its claim to exceptional durability in the treatment of wet age-related macular degeneration (wet AMD). Notably, AXPAXLI demonstrated a median time of 39 weeks to clinically meaningful disease worsening, measured as a 30 µm increase in Central Subfield Thickness (CSFT), compared to just 16 weeks with aflibercept—a 23-week difference. For more severe worsening (75 µm CSFT increase), AXPAXLI extended the median time to 46 weeks versus 24 weeks with aflibercept, creating a 22-week edge in disease control.

The observed hazard ratios imply that AXPAXLI recipients faced 30% (for 30 µm) and 50% (for 75 µm) lower risk of anatomic deterioration between Weeks 8 and 52 compared to patients on aflibercept.

Visual Gains Maintained Across All Quartiles Through 52 Weeks

Beyond durability, AXPAXLI’s efficacy was reinforced by visual acuity outcomes. Across quartiles grouped by baseline BCVA (best corrected visual acuity), patients on AXPAXLI generally maintained gains achieved during the initial loading phase. The most visually impaired subgroup at screening saw the greatest benefit, gaining +11.8 ETDRS letters with AXPAXLI at Week 52 compared to +8.5 letters with aflibercept. In subgroups with near-normal vision at baseline, visual acuity was essentially preserved throughout the 52-week period.

Rescue-Free Rates and Sustained Outcomes Point to Real-World Benefits

AXPAXLI’s trial arm consistently showed higher rates of patients avoiding rescue injections through key timepoints. By Week 24, 81% of AXPAXLI patients were rescue-free; even at Week 36, 75% remained so, with negligible additional vision loss. This endurance is notable compared to real-world data, where up to 40% of patients discontinue standard wet AMD treatment within a year. The SOL-1 findings suggest AXPAXLI could reduce the treatment burden, offering longer-lasting benefits from fewer interventions.

Favorable Safety Profile and NDA Submission Plans

Tolerability of AXPAXLI remained reassuring, with floaters (an observed side effect) resolving by 20 weeks on average and no impactful vision losses or significant adverse events reported. These results pave the way for Ocular Therapeutix to pursue a New Drug Application (NDA) submission based on the SOL-1 trial alone—reflecting recent regulatory shifts that favor single-pivotal trial approvals for well-controlled studies.

Key Takeaways for Investors and Clinicians

The SOL-1 week 52 dataset positions AXPAXLI as a compelling candidate to redefine wet AMD management—delivering durable disease control and sustained vision improvement through a safer, less burdensome regimen. With a 23 to 22-week advantage over aflibercept in delaying anatomic worsening, AXPAXLI’s decentralized dosing strategy aligns with a growing preference for treatment durability in real-world practice.

Investors and clinicians alike will want to monitor the upcoming FDA discussions and NDA milestones closely. If regulatory trends continue as anticipated, AXPAXLI could soon emerge as a transformative option for millions affected by wet AMD worldwide.

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