Key Takeaways Axpaxli demonstrated significantly longer durability than aflibercept, delaying disease worsening by over 20 weeks Visual acuity gains were largely maintained through 1 year, with strong outcomes across patient subgroups and up to 75% of patients remaining rescue-free at 9 months Ocular Therapeutix plans to submit an NDA based on the single Phase 3 SOL-1 trial, aligning with evolving FDA guidance Ocular Therapeutix announced new positive findings from post-hoc analyses of its phase 3 SOL-1 clinical trial evaluating Axpaxli (OTX-TKI) for the treatment of wet age-related macular degeneration (AMD). The data werw presented at the 14th Annual Vit-Buckle Society (VBS) Meeting. “This additional data strengthens our conviction in Axpaxli’s potential to redefine retina care,” said Pravin U. Dugel, MD, Executive Chairman, President, and CEO of Ocular Therapeutix. “We are seeing a consistent and compelling profile—unmatched durability alongside strong, sustained disease control—which could allow clinicians to rethink how wet AMD is managed.” The SOL-1 trial met its superiority primary endpoint and demonstrated statistically significant results across multiple secondary endpoints. Newly presented analyses further emphasize Axpaxli’s durability compared to aflibercept (2 mg), a commonly used anti-VEGF therapy. Key findings include: Delayed disease progression: Patients treated with Axpaxli experienced significantly longer times before clinically meaningful worsening in central subfield thickness (CSFT). Median time to ≥30 µm CSFT increase: 39 weeks (Axpaxli) vs. 16 weeks (aflibercept) Median time to ≥75 µm increase: 46 weeks vs. 24 weeks Reduced risk of worsening: Axpaxli reduced the risk of anatomical worsening by: 30% for ≥30 µm CSFT increase (hazard ratio 0.7; P=0.0028) 50% for ≥75 µm increase (hazard ratio 0.5; P<0.0001) These findings suggest a sustained therapeutic effect following a single dose, supporting the drug’s potential to reduce treatment burden. In addition to anatomical improvements, Axpaxli demonstrated durable visual acuity outcomes: Patients generally maintained vision gains achieved during the initial loading phase through Week 52. Those with poorer baseline vision saw the greatest improvements, with gains of +11.8 ETDRS letters, compared to +8.5 letters in the aflibercept group. Patients with near-normal baseline vision maintained stable outcomes, reflecting preservation rather than improvement. Among patients who did not require rescue therapy: 81% remained rescue-free at Week 24 75% remained rescue-free at Week 36, with minimal vision loss Axpaxli continued to demonstrate a generally well-tolerated safety profile. Reported vitreous floaters—associated with the drug’s hydrogel delivery system—resolved over time (average ~20 weeks) and did not impact vision. No significant adverse events such as endophthalmitis or vasculitis were observed. Ocular Therapeutix confirmed it remains on track to submit a new drug application (NDA) for Axpaxli based on the SOL-1 trial alone, pending discussions with the FDA. Recent FDA commentary supports a shift toward approving therapies based on a single well-controlled phase 3 trial, a framework expected to roll out over the coming months. This regulatory direction aligns with the company’s timeline and strategy, according to Ocular. Axpaxli is a bioresorbable intravitreal hydrogel incorporating axitinib, designed for sustained drug delivery. The phase 3 SOL-1 trial enrolled 344 treatment-naïve wet AMD patients across more than 100 sites in the U.S. and Argentina. The study evaluates both safety and long-term efficacy, with patients followed through 104 weeks.