Ocular Therapeutix reported additional Phase 3 SOL-1 analyses showing AXPAXLI delivered sustained disease control, durable visual outcomes, and a well-tolerated safety profile through 52 weeks in wet AMD.
Written By: Mahathi Palivela, PharmD
Reviewed By: Pharmacally Editorial Team
Ocular Therapeutix reported additional Week 52 analyses from the Phase 3 SOL-1 superiority trial of AXPAXLI (OTX-TKI) in wet age-related macular degeneration (AMD), showing sustained disease control, durable visual outcomes, and a generally well-tolerated safety profile compared with aflibercept. The findings were presented at the 14th Annual Vit-Buckle Society meeting and further support the investigational therapy’s long-acting profile.
Durable disease control and efficacy signals
AXPAXLI achieved statistical significance in the first three of five hierarchical key secondary endpoints, with six additional prespecified functional and anatomic endpoints also met. Post-hoc analyses showed significantly lower risk of anatomic worsening from Week 8 versus aflibercept.
Median time to ≥30 µm central subfield thickness (CSFT) increase was 39 weeks with AXPAXLI versus 16 weeks with aflibercept, corresponding to a 30% lower risk of worsening (hazard ratio 0.7; descriptive p=0.0028). For ≥75 µm increase, median time was 46 weeks versus 24 weeks, representing a 50% lower risk (hazard ratio 0.5; descriptive p<0.0001).
Sustained visual outcomes
Visual acuity gains achieved during the loading phase were generally maintained through Week 52 across baseline BCVA quartiles. Patients with the lowest baseline vision achieved +11.8 ETDRS letters compared with +8.5 letters with aflibercept, while those with near-normal baseline vision maintained stable acuity in both arms.
Among rescue-free patients, 81% of AXPAXLI-treated subjects remained rescue-free at Week 24 and 75% at Week 36, maintaining visual gains with minimal letter loss.
Safety and tolerability
AXPAXLI demonstrated a generally well-tolerated safety profile. Reported vitreous floaters resolved over time, with drug particles no longer visible after a mean of 20 weeks, consistent with hydrogel bioresorption and drug release, without impacting vision.
Company and investigator perspectives
Pravin U. Dugel, MD, Executive Chairman, President and CEO of Ocular Therapeutix stated that the analyses reinforce AXPAXLI’s durability and sustained disease control, highlighting prolonged time to CSFT worsening and continued plans to submit a New Drug Application based on SOL-1 alone, subject to FDA discussions.
Andrew A. Moshfeghi, MD, MBA, FASRS, from the USC Roski Eye Institute emphasized that visual acuity remained stable throughout the study, with most patients remaining rescue-free for up to 12 months and a reassuring safety profile without significant inflammatory complications.
Trial overview
The registrational Phase 3 SOL-1 trial (NCT06223958) randomized 344 treatment-naïve patients with wet AMD to a single dose of AXPAXLI or aflibercept following an eight-week loading phase.
Previously reported topline results showed the primary endpoint was met, with 74.1% of AXPAXLI-treated patients maintaining vision at Week 36, representing a 17.5% risk difference versus aflibercept (p=0.0006). At Week 52, 65.9% maintained vision, corresponding to a 21.1% risk difference (p<0.0001).
References
About the Writer
Mahathi Palivela is pursuing PharmD and has a strong interest in Clinical Pharmacy and Patient safety. She is passionate about handling and analyzing patient data, and translating clinical insights into clear, meaningful summaries. She aims to apply this interest in Medical Writing and Pharmacovigilance, focusing on improving patient outcomes through careful data interpretation and communication .