Phase IIb RELIEF trial win with licaminlimab

Swiss ophthalmology specialist Oculis Holding (Nasdaq: OCS) has announced positive top-line results from its Phase IIb RELIEF trial with licaminlimab (OCS-02), a novel anti-TNFα biologic eye drop with an established dual anti-inflammatory and anti-apoptotic mechanism of action in patients with dry eye disease (DED).

The Phase IIb RELIEF trial is a multicenter, randomized, double-masked, vehicle-controlled trial evaluating the efficacy and safety of licaminlimab in subjects with signs of DED ( NCT05896670). The trial also evaluated the efficacy and safety of licaminlimab in a subpopulation of subjects with a TNFR1-related genotype as prespecified in the protocol. The candidate was in-licensed from Swiss pharma giant Novartis (NOVN: VX) in 2019.

Oculis reported a statistically-significant result on one secondary endpoint, at one time point, in the subpopulation. Corneal inflammation favored licaminlimab after 15 days, and the difference was significant after 43 days.