Ocular Therapeutix (OCUL) Study result presentation summary

Study design and patient population

• Compared OTX-TKI 0.45 mg to aflibercept 2 mg in treatment-naïve neovascular AMD patients with BCVA ≥54 ETDRS letters and CSFT <500 μm.

• Randomization required BCVA gain ≥10 ETDRS letters or BCVA ≥84 ETDRS letters and CSFT ≤350 μm.

• Primary endpoint was maintenance of visual acuity (<15 ETDRS letter loss) at week 36.

• Rescue treatment triggered by ≥15 ETDRS letter loss or new macular hemorrhage.

Efficacy and durability results

• OTX-TKI demonstrated unmatched durability, with >9 months before most subjects required rescue treatment.

• At week 36, 74.1% of OTX-TKI subjects remained rescue-free versus 55.8% for aflibercept; at week 52, 65.9% versus 44.2%.

• Statistically significant differences favored OTX-TKI for both primary and key secondary endpoints (P=0.0006 and P<0.0001).

Visual and anatomic outcomes

• OTX-TKI maintained visual acuity and central subfield thickness comparable to aflibercept through 36 weeks.

• Mean change in BCVA and CSFT from baseline was similar between groups, with 74.7% of OTX-TKI and 56.4% of aflibercept subjects remaining rescue-free.

• OTX-TKI showed favorable control of retinal fluid volume compared to aflibercept.