Oculis Holding AG announced positive topline results from its Phase 2b RELIEF trial with licaminlimab, a novel anti-TNFα biologic eyedrop with an established dual anti-inflammatory and anti-apoptotic mechanism of action in patients with dry eye disease (DED). For the full trial population (n=122), treatment effect favoring licaminlimab was observed in multiple sign endpoints including fluorescein staining in the total cornea, inferior corneal, central corneal and nasal conjunctival regions, and in the Schirmer’s test, the company stated in a press release.

For the subpopulation of patients with the TNFR1 genetic biomarker (n=23), treatment effect favoring licaminlimab was observed in multiple sign endpoints including fluorescein staining in the total cornea, inferior corneal, central corneal, nasal conjunctival, total conjunctival and total ocular surface regions, in the Schirmer’s test, and in conjunctival redness. 

In addition, rapid and favorable treatment effect in favor of licaminlimab on corneal inflammation was observed as early as Day 15 that was significant at Day 43, as measured by the difference in mean change from baseline vs vehicle for inferior corneal fluorescein staining score: -0.59 (CI: -1.165, -0.017). The treatment effect also increased over time.

Licaminlimab was well tolerated, the company said. The incidence of ocular treatment emergent adverse events (TEAEs) in the study eye was 11.5% in the licaminlimab group and 10.2% in the vehicle group. TEAEs in the fellow eye were similar to the study eye. All ocular TEAEs were mild and transient, and there were no serious ocular adverse events observed with licaminlimab. Drop comfort was also evaluated and was similar to artificial tears. 

The company announced plans to conduct an end-of-Phase 2 meeting with the FDA to discuss the registrational path for licaminlimab in DED and finalize the Phase 3 development plan.