Ocular Therapeutix (OCUL) Investor presentation summary

Study design

• SOL-1 randomized treatment-naïve nAMD patients 1:1 to OTX-TKI 0.45 mg or aflibercept 2 mg; 170 and 172 patients, respectively, were included in the full analysis set.

• Primary endpoint: proportion maintaining visual acuity, defined as <15 ETDRS letters of BCVA loss from baseline, at Week 36.

• Participants had strong baseline vision: mean BCVA 80.8 letters with OTX-TKI and 79.2 with aflibercept, both ~20/25.

Efficacy and durability

• SOL-1 met its primary endpoint: 74.1% with OTX-TKI vs 55.8% with aflibercept maintained vision at Week 36 (P=0.0006).

• At Week 52, 65.9% with OTX-TKI vs 44.2% with aflibercept maintained vision (P<0.0001).

• OTX-TKI hydrogel remained visible in >90% of patients at Month 6 and ~50% at Month 9; axitinib release continued while the hydrogel persisted.

• At Week 36, 74.7% of OTX-TKI patients were supplemental-injection-free vs 56.4% with aflibercept; at Week 52, rates were 68.8% vs 47.7%.

Early fluid control

• At Week 8, quantitative dryness (total retinal fluid ≤10 nL) was observed in 70.6% of OTX-TKI patients and 75.0% of aflibercept patients.

• ~70% of OTX-TKI patients dry at Week 8 maintained quantitative dryness through Week 36; among this subgroup, 80.0% were supplemental-injection-free at Week 36.

• Week 8 dry-status subgroups showed sustained BCVA outcomes through Week 36; OTX-TKI patients with >10 nL fluid increase had a 52.3% supplemental-free rate at Week 36.