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 dependency.

• 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

• At week 36, 74.1% of AXPAXLI subjects maintained vision (loss of <15 ETDRS letters) vs. 55.8% for aflibercept (p=0.0006); at week 52, 65.9% maintained vision (p<0.0001).

• AXPAXLI showed superiority in key secondary endpoints, including fewer subjects losing ≥10 letters and tighter anatomic control on OCT.

• Over 80% of patients dry at baseline maintained vision at 9 months; 68.8% of AXPAXLI subjects were rescue-free at week 52.

• Durability extended toward a 9–12 month treatment horizon with a single injection.

Safety profile

• No treatment- or procedure-related serious adverse events, endophthalmitis, or retinal vasculitis were observed.

• Main 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 intraocular inflammation were consistent with rates seen in similar populations and resolved without sequelae.