BEDFORD, Mass., April 13, 2026
Ocular Therapeutix, Inc. has reported positive Week 52 data from its Phase 3 SOL-1 trial of AXPAXLI™, highlighting unmatched durability and sustained disease control in wet age-related macular degeneration (AMD). The investigational therapy demonstrated significant improvements in both anatomical and visual outcomes, positioning it as a potential next-generation retinal treatment with reduced treatment burden and strong regulatory momentum toward New Drug Application (NDA) submission
Strong Clinical Efficacy and Sustained Disease Control
The SOL-1 trial data revealed that AXPAXLI achieved statistically significant results across multiple key endpoints, with patients showing prolonged control of retinal thickness and reduced disease progression risk. Notably, the median time to clinically meaningful retinal worsening was extended up to 46 weeks, compared to significantly shorter durations in comparator treatments, demonstrating superior durability in managing wet AMD. Additionally, patients treated with AXPAXLI experienced a 30–50% lower risk of disease progression, reinforcing its robust efficacy profile and long-acting therapeutic potential. These findings indicate that AXPAXLI may transform current treatment paradigms, which often rely on frequent intravitreal injections.
Visual Outcomes and Patient-Centric Benefits
Beyond anatomical improvements, AXPAXLI delivered consistent and sustained visual acuity gains up to Week 52, particularly in patients with lower baseline vision, where improvements reached +11.8 ETDRS letters compared to +8.5 letters in standard therapy. Importantly, up to 75% of patients remained rescue-free at nine months, highlighting its ability to maintain vision with fewer interventions. The therapy also demonstrated a favorable safety profile, with no major adverse events such as vasculitis or endophthalmitis, and transient floaters resolving naturally without impacting vision. These outcomes emphasize AXPAXLI’s potential to reduce treatment burden, improve adherence, and enhance long-term patient outcomes, addressing key limitations of existing therapies.
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Regulatory Pathway and Market Impact
Ocular Therapeutix is now on track to submit an NDA based on the SOL-1 trial alone, aligning with evolving FDA guidance supporting single pivotal trial approvals for well-designed studies. This strategic pathway could accelerate time-to-market, enabling faster access for patients suffering from wet AMD, a condition affecting approximately 14.8 million individuals globally. The company’s proprietary ELUTYX™ hydrogel technology, which enables sustained drug delivery of axitinib, underpins AXPAXLI’s differentiated profile and supports its potential broad clinical adoption upon approval.
With strong clinical validation, regulatory alignment, and significant unmet need in retinal diseases, AXPAXLI represents a breakthrough innovation in ophthalmology, offering the promise of long-lasting efficacy, reduced injection frequency, and improved patient quality of life. As Ocular Therapeutix advances toward regulatory submission, the therapy is poised to reshape the competitive landscape of wet AMD treatment and deliver meaningful value to patients and healthcare systems worldwide.
Source: Ocular Therapeutix press release
