AXPAXLI Week 52 SOL-1 Update Highlights Durability in Wet AMD

SOL-1 is a Phase 3 trial evaluating AXPAXLI in treatment-naïve wet AMD. The sponsor reported that SOL-1’s primary endpoint was assessed at Week 36 (proportion maintaining vision, defined as a <15 ETDRS-letter loss in BCVA from baseline) and that 65.9% of AXPAXLI-treated participants maintained vision at Week 52 versus aflibercept. They also reported a 21.1% risk difference and a descriptive p value below 0.0001 for that comparison. The sponsor described the Week 52 topline data as positive in this treatment-naïve wet AMD population.

In SOL-1, researchers described AXPAXLI as part of a multi-center, double-masked, randomized 1:1 Phase 3 superiority trial across more than 100 sites in the United States and Argentina. The study randomized 344 treatment-naive participants with wet AMD, and 2 withdrew before receiving Day 1 treatment. Enrollment occurred at sites in both countries, and masking was maintained for participants and designated trial personnel. The protocol included an eight-week loading segment before randomization, planned re-dosing at weeks 52 and 76, and safety follow-up through week 104. These elements outlined a masked parallel-group study extending beyond the first year.

In separate post-hoc analyses, the authors reported a longer median time from Week 8 to CSFT increases of ≥30 µm (39 vs 16 weeks) and ≥75 µm (46 vs 24 weeks) with AXPAXLI compared with aflibercept. The time-to-event analyses used Week 8 as the reference point for comparing later anatomic worsening between groups. Estimated hazard ratios in those analyses favored AXPAXLI, consistent with a lower reported risk of anatomic worsening during follow-up. Researchers also observed that visual acuity gains achieved during loading were generally maintained through Week 52 across screening BCVA quartile subgroups. Overall, the sponsor reported post-hoc analyses describing anatomic and visual outcomes through Week 52.

A separate rescue-free analysis focused on participants who had not required supplemental treatment after randomization. The sponsor reported that 81% of AXPAXLI-treated participants were rescue-free at Week 24, and 75% remained rescue-free at Week 36. Within that subgroup, investigators noted little additional BCVA loss between those time points. These rescue-free observations were presented as a treatment-burden-related finding within the Week 52 update.

Through Week 52, investigators described the study as generally well tolerated. Among participants with vitreous floater adverse events, drug particles were no longer visible after a mean of 20 weeks. The reported floater course was described without evidence of vision impact in affected participants. In an investigator quote included in the press release, the safety profile was described as reassuring, with no significant adverse events such as endophthalmitis or vasculitis, and with floaters resolving without impacting patients’ vision. Overall, tolerability was the safety theme emphasized in the Week 52 presentation.

Key Takeaways

• SOL-1 was reported as a randomized Phase 3 comparison of AXPAXLI and aflibercept in treatment-naive wet AMD.
• The sponsor described Week 52 vision-maintenance results alongside post-hoc durability and visual outcome findings through one year.
• Rescue-free subgroup observations and a generally well-tolerated safety profile were also described through Week 52.