Ocular Therapeutix Shares Jump 28% as SOL-1 Completes Week 52 Dosing
Ocular Therapeutix's shares surged 28% premarket after completing randomization and Week 52 re-dosing of 344 treatment-naive patients in its SOL-1 Phase 3 wet AMD trial and scheduling data presentation at the Macula Society meeting Feb 25–28, 2026. Its SOL-R trial has enrolled 631 subjects with topline results due Q1 2027.
1. SOL-1 Phase 3 Trial Progress
SOL-1 randomized 344 treatment-naive wet AMD subjects, completed all Week 52 visits and re-dosing per baseline assignments, and will present 52-week efficacy and durability data at the Macula Society meeting Feb 25–28, 2026 while continuing patient follow-up to Week 104.
2. SOL-R and HELIOS-3 Programs
The SOL-R program has surpassed its 600-patient target with 631 randomized subjects and expects topline primary endpoint results in Q1 2027; the HELIOS-3 trial is evaluating AXPAXLI in roughly 930 NPDR patients, building on Phase 1 data showing 46.2% and 23.1% DRSS improvements without worsening.
3. Potential Regulatory Pathway
Ocular Therapeutix plans to seek FDA approval for AXPAXLI in wet AMD via a Section 505(b)(2) NDA submission based on Week 52 data, potentially accelerating the review process by up to two months, while acknowledging ongoing clinical, regulatory and financing risks.
4. Market Reaction
Investors drove Ocular Therapeutix shares up 28% premarket on Tuesday, reflecting anticipation of upcoming Phase 3 data releases and the potential for a pivotal NDA filing catalyst for its AXPAXLI hydrogel therapy.