Oculis (OCS) Study Result summary

Study design and objectives

• RELIEF phase II-B trial was a randomized, masked, vehicle-controlled, multi-center study in moderate to severe dry eye disease, focusing on signs such as corneal/conjunctival staining, redness, and Schirmer's test, and stratified by TNFR1 genetic biomarker status.

• The trial included 122 patients, with a subgroup of 23 TNFR1 genotype-positive patients, randomized to active or vehicle arms.

• The study aimed to confirm efficacy in signs, validate the TNFR1 biomarker for predictive response, and select endpoints for phase III.

• The trial design included a run-in with artificial tears, followed by six weeks of treatment and two weeks of follow-up.

• Simple, rapid genetic testing for TNFR1 biomarker was integrated to identify high responders.

Efficacy results

• Licaminlimab showed rapid and meaningful improvement in multiple signs, with a -0.12 change in inferior corneal staining in the full population and -0.59 in TNFR1-positive patients at day 42, exceeding benchmarks from approved therapies.

• In TNFR1 genotype-positive patients, the response was fivefold higher in signs and sevenfold in symptoms, with rapid onset seen as early as day 14.

• Statistically significant improvements were observed in the biomarker group, with confidence intervals not crossing zero and p-values <0.05.

• All study goals were achieved, including validation of the TNFR1 biomarker as a predictor of response and selection of corneal staining as the primary endpoint for Phase 3.

• The product demonstrated efficacy in both signs and symptoms across previous and current trials, with consistent results.

Safety and tolerability

• Licaminlimab was well-tolerated, with a low incidence of mild, transient adverse events similar to vehicle; no serious ocular adverse events were reported.

• Most ocular treatment-emergent adverse events were mild and transient, with instillation site irritation (8.2%) and pruritus (3.3%) being the most common.

• No burning or blurred vision events were reported, and drop comfort was rated highly by patients, consistent with artificial tears.

• The safety profile supports its use in a population sensitive to irritation and adverse effects.