SOL‑1 Topline: AXPAXLI Shows Superiority and Durability in Wet AMD

The SOL‑1 Phase 3 superiority trial press release reports that AXPAXLI (OTX‑TKI) met the Week 36 superiority primary endpoint in wet age-related macular degeneration (AMD), defined as the proportion of subjects maintaining vision (a loss of <15 ETDRS letters of BCVA from baseline).

In the company’s topline statement, 74.1% of subjects in the AXPAXLI arm met this endpoint versus 55.8% in the aflibercept (2 mg) arm, corresponding to a 17.5% risk difference with p=0.0006 under the pre-specified statistical model. The release frames Week 52 as a separate durability assessment reported alongside the Week 36 findings.

As described in the release, SOL‑1 is an FDA-aligned superiority trial conducted under a Special Protocol Assessment, and the company reports that multiple sensitivity analyses for the Week 36 primary endpoint were also statistically significant under a pre-specified analysis plan. Design details presented include an initial eight-week loading segment with two aflibercept (2 mg) injections prior to randomization; the trial then compared a single injection of AXPAXLI (0.45 mg) with a single injection of aflibercept (2 mg).

The release also states that the study remained masked through the Week 52 durability assessment, that subjects were assessed monthly, and that protocol-defined rescue included supplemental aflibercept (2 mg) for criteria such as ≥15-letter BCVA loss from baseline or new vision-threatening macular hemorrhage. These design and analysis-plan elements (including predefined statistical rules) are presented in the press release to support interpretation of the Week 36 and Week 52 endpoints.

For the Week 52 durability assessment, the press release reports that 65.9% of subjects in the AXPAXLI (OTX‑TKI) arm maintained vision versus 44.2% in the aflibercept (2 mg) arm (risk difference 21.1%; p<0.0001). In the same topline summary, on-protocol rescue-free rates for AXPAXLI are reported as 80.6%, 74.7%, and 68.8% at Weeks 24, 36, and 52, respectively; the aflibercept (2 mg) arm is reported as 72.1%, 56.4%, and 47.7% at those timepoints. The release also describes an anatomic exploratory endpoint of central subfield thickness (CSFT) control within 30 μm from baseline at Week 36 (55.9% for AXPAXLI vs 37.8% for aflibercept; nominal p=0.0013) and reports a Week 52 CSFT comparison of 44.1% versus 34.9% (nominal p=0.1094).

On safety, the press release states that, as of a Week 52 database lock (February 5, 2026), AXPAXLI was generally well-tolerated in SOL‑1, with no observed treatment-related ocular or systemic serious adverse events. It also reports no events of endophthalmitis, occlusive or non-occlusive retinal vasculitis, retinal detachment, or implant migration to the anterior chamber in the AXPAXLI arm. The text summary does not include frequency breakdowns for other adverse events.

Regarding next steps, the company states that it intends to submit a New Drug Application based on SOL‑1 data, subject to planned formal discussions with the U.S. FDA.

Key Takeaways:

• SOL‑1 met a Week 36 superiority primary endpoint defined as maintaining vision with <15 ETDRS letter loss from baseline, with statistical significance under a pre-specified model.
• Week 52 maintained-vision results, along with reported rescue-free rates and CSFT-control comparisons, are presented in the release as durability-related readouts.
• The company reports a topline safety overview (including no treatment-related ocular or systemic serious adverse events) and states an intent to pursue NDA submission subject to planned FDA discussions, with detailed data planned for the Macula Society meeting.