Licaminlimab has positive effect on dry eye signs in phase 2b trial
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Improvements in multiple sign efficacy endpoints were reported for licaminlimab in patients with dry eye disease, with more pronounced effects in patients with a TNFR1 genetic biomarker, according to an Oculis press release.
“I am very excited to see that licaminlimab, with its dual anti-inflammatory and anti-apoptotic mechanism of action, targets the origin of DED and has the potential to be truly disease modifying as shown by improvements in several clinical signs of DED, including corneal staining,” Christophe Baudouin, MD, PhD, a member of the Oculis scientific advisory board, said in the release.
In the multicenter, randomized, double-masked, vehicle-controlled phase 2b RELIEF trial, researchers evaluated the efficacy and safety of licaminlimab, an anti-TNF-alpha eye drop candidate, in 122 patients with dry eye disease (DED). Participants were randomly assigned 1:1 to receive either licaminlimab or vehicle for a 6-week treatment period followed by a 2-week follow up.
The treatment group demonstrated efficacy in multiple endpoints including fluorescein staining in the total cornea, inferior corneal, central corneal and nasal conjunctival regions and in the Schirmer’s test.
In the TNFR1 subpopulation of 23 patients, the treatment effect 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.
This subgroup also demonstrated a favorable treatment effect on corneal inflammation by day 15, which became significant at day 43.
The treatment was well tolerated, with ocular treatment-emergent adverse events in the study eye in 11.5% of the licaminlimab group and 10.2% of the vehicle group. Participants reported that drop comfort was similar to artificial tears.
“The precision medicine approach with licaminlimab could be a groundbreaking paradigm shift in ophthalmology and the treatment of DED,” Eric D. Donnenfeld, MD, chair of the cornea scientific advisory board for Oculis, said in the release. “The current approach of ‘trial and error’ and our inability to predict response for this highly heterogenous population leads to a low level of patient satisfaction.”
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