Ocular Therapeutix will unveil 52-week topline data from SOL-1, its Phase 3 superiority trial of the intravitreal axitinib hydrogel AXPAXLI for wet age-related macular degeneration, at the Macula Society meeting on February 25–28, 2026. Pending positive results and planned FDA interactions, the company intends to file an NDA based on this single registrational study under a Special Protocol Assessment, leveraging the 505(b)(2) pathway to potentially trim review timelines. In parallel, Ocular completed randomization of 631 subjects in SOL-R, a non-inferiority Phase 3 that now targets topline results in the first quarter of 2027, commenced the HELIOS-3 Phase 3 program in non-proliferative diabetic retinopathy, and expects to start the SOL-X open-label extension in the second quarter of 2026. The company ended 2025 with $737.1 million in cash and projects runway into 2028, even as Dextenza revenue declined in a tougher reimbursement environment and R&D investment accelerated ahead of potential launch.
The strategic question is whether Ocular can reset the wet AMD treatment paradigm with a single-trial NDA and a superiority claim, and do so in a market already reshaped by extended-interval anti-VEGF regimens. The SOL-1 design compares a single dose of AXPAXLI against a single 2 mg aflibercept dose, with a primary endpoint at week 36 and re-dosing at weeks 52 and 76. If the data show superiority and a clean safety profile, Ocular could be first to secure superiority language versus a single aflibercept dose for wet AMD—an important commercial lever—but FDA’s acceptance of a one-trial filing and the translatability of trial procedures to real-world practice will be closely scrutinized.
Why it matters now: undertreatment and discontinuation continue to erode long-term outcomes in retina clinics despite potent anti-VEGF agents. A long-acting, bioresorbable TKI designed for twice-yearly dosing promises to smooth disease control, reduce visit burden, and potentially mitigate fibrosis and atrophy associated with pulsatile therapy. For patients, the appeal is fewer injections with sustained effect; for retina specialists, clinic flow could shift toward planned, semiannual procedures and proactive monitoring rather than reactive rescue. Payers will press for proof that reduced injection frequency translates into durable vision maintenance in routine care, not just enriched trial populations. Superior efficacy claims could support earlier-line positioning, yet step therapy to lower-cost anti-VEGFs may persist unless health economic models quantify fewer visits, lower procedural utilization, and avoided vision loss events.
Competitive context is unforgiving. Eylea HD and Vabysmo have already extended dosing intervals for large segments of patients, and multiple long-acting platforms are advancing, including sustained delivery and TKI-based approaches. To break through, AXPAXLI must demonstrate not just non-inferiority with fewer injections, but a clinically meaningful edge that changes physician behavior and payer algorithms. The SOL-R design, with a six-month screening and loading phase to exclude early persistent fluid and high fluctuation, aims to de-risk outcomes but could raise questions about real-world generalizability. The planned SOL-X extension and HELIOS-3 in diabetic retinopathy are well-timed to build a durability and disease-modification narrative across retinal diseases that remain massively undertreated earlier in their course.
Commercial execution will hinge on Medical Affairs from day one: defining monitoring cadence in practice, clarifying rescue criteria, educating on TKI mechanistic differentiation, and rapidly generating real-world evidence on adherence, safety signals, and visual function over multiple re-doses. With a strengthened balance sheet and pre-commercial investments underway, Ocular has the resources to launch—but not unlimited time if the market moves further toward extended-interval biologics and potential biosimilar-driven step edits.
All eyes now turn to the Macula Society stage. If SOL-1 delivers superiority with durable vision maintenance and manageable safety, does AXPAXLI become the first sustained TKI to earn front-line consideration, or will payers and clinics insist on an anti-VEGF-first sequence that blunts its uptake until SOL-R reads out in 2027?
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
