Ocular Therapeutix (OCUL) Study presentation summary

Clinical program overview

• OTX-TKI is being evaluated in multiple Phase 3 trials for neovascular age-related macular degeneration (nAMD), including superiority and non-inferiority studies, with complementary extension studies for long-term safety and disease modification.

• The SOL-1 trial compares a single OTX-TKI injection to aflibercept, while SOL-R and SOL-X assess repeat dosing and long-term outcomes.

• Additional studies target diabetic retinopathy (HELIOS-1, HELIOS-3), focusing on progression and vascular leakage.

Efficacy and durability results

• OTX-TKI met the primary endpoint in SOL-1, with 74.1% maintaining vision at 9 months and 65.9% at 12 months, outperforming aflibercept (P=0.0006 and P<0.0001, respectively).

• Subjects treated with OTX-TKI had a significantly lower risk of requiring rescue treatment during the first year, with a ~6-month advantage over aflibercept.

• OTX-TKI provided sustained fluid control and visual/anatomic stability, aligning favorably with real-world outcomes.

Safety and tolerability

• OTX-TKI was generally well tolerated, with most ocular adverse events being mild or moderate and resolving without severe complications.

• No cases of endophthalmitis or retinal vasculitis were reported; incidence of macular atrophy was similar or lower compared to aflibercept.

• Appearance of vitreous floaters was mild to moderate and coincided with drug elution, with no associated intraocular inflammation.