Ocular Therapeutix has released additional one‑year results from its Phase 3 SOL‑1 trial evaluating AXPAXLI (formerly OTX‑TKI) for the treatment of neovascular age‑related macular degeneration (wet AMD). New post‑hoc analyses, presented at the 14th Annual Vit‑Buckle Society (VBS) meeting, further highlight the therapy’s long durability, sustained anatomic disease control, and favorable safety profile.
SOL‑1 is a randomized, superiority Phase 3 study comparing AXPAXLI with aflibercept 2 mg. According to the company, the latest analyses reinforce AXPAXLI’s ability to maintain disease control well beyond the loading phase, a key unmet need in wet AMD management.
Sustained Anatomic Control
One of the most notable findings involved time to worsening of central subfield thickness (CSFT) measured by OCT. From Week 8 onward, patients receiving AXPAXLI experienced significantly delayed anatomic deterioration compared with those treated with aflibercept.
The median time to a clinically meaningful CSFT increase of at least 30 µm was approximately 39 weeks with AXPAXLI, compared with 16 weeks in the control arm. For larger CSFT increases of 75 µm or more, the median time extended to about 46 weeks in the AXPAXLI group versus 24 weeks with aflibercept. These results translate into a substantially lower risk of anatomic worsening over the course of one year.
Visual Acuity Outcomes Across Patient Subgroups
Visual acuity improvements achieved during the initial loading phase were generally maintained through Week 52 in patients treated with AXPAXLI, regardless of baseline best‑corrected visual acuity (BCVA) quartile. Patients entering the study with poorer vision experienced the greatest gains, while those with near‑normal baseline vision largely preserved their acuity over time.
Among patients who did not require rescue therapy, visual outcomes remained stable through mid‑study assessments. More than 80% of AXPAXLI‑treated patients were rescue‑free at six months, with three‑quarters remaining rescue‑free at nine months.
Safety and Tolerability
AXPAXLI continued to demonstrate a generally well‑tolerated safety profile. Vitreous floaters, when reported, were transient and resolved as the hydrogel delivery system biodegraded, with drug particles no longer visible after an average of approximately 20 weeks. Importantly, these events were not associated with vision loss, and no serious safety concerns such as endophthalmitis or retinal vasculitis were reported.
Regulatory Outlook
Ocular Therapeutix stated that it remains on track to submit a New Drug Application for AXPAXLI based solely on the SOL‑1 trial, pending formal discussions with the U.S. Food and Drug Administration. The company noted that recent FDA commentary supports the acceptability of a single, well‑controlled pivotal Phase 3 trial as the basis for approval, aligning with its regulatory strategy.
If approved, AXPAXLI could represent a new long‑acting treatment option for wet AMD, potentially reducing treatment burden while maintaining durable disease control and visual outcomes.
