Ocular Therapeutix (OCUL) Study update summary

Study design and mechanism of action

• SOL-1 was a phase III, FDA-aligned, superiority trial evaluating AXPAXLI (OTX-TKI) in wet AMD, enrolling 344 subjects with high baseline vision and anti-VEGF dependence.

• AXPAXLI uses axitinib, a potent intracellular pan-VEGF and pan-PDGF inhibitor, delivered via a bioresorbable hydrogel for sustained, predictable drug release over 9–12 months.

• The hydrogel platform allows for standard intravitreal injection, no surgery, and synchronized drug release and resorption.

Efficacy results

• AXPAXLI met the primary endpoint: at week 36, 74.1% maintained vision (loss <15 ETDRS letters) vs. 55.8% for aflibercept (p=0.0006); at week 52, 65.9% maintained vision (p<0.0001).

• Fewer AXPAXLI subjects lost ≥10 letters at both timepoints; anatomic control was tighter, with 55.9% maintaining central subfield thickness within 30 microns at week 36.

• Rescue-free rates were high: 74.7% at week 36 and 68.8% at week 52, with delayed time to first rescue compared to aflibercept.

• Durability extended toward a 9–12 month treatment horizon after a single injection, unprecedented in phase III wet AMD trials.

Safety profile

• No treatment- or procedure-related serious adverse events; no endophthalmitis or retinal vasculitis observed.

• Most common non-serious ocular event was vitreous floaters (12.4%), attributed to hydrogel dissolution; these were transient, peripheral, physician-reported, and had no impact on vision.

• Cataract rates (7.1%) and mild to moderate intraocular inflammation were consistent with rates seen in similar populations and resolved without sequelae.