Eleven Biotherapeutics announced top-line results from the Phase 3 clinical trial of isunakinra (EBI-005) for the treatment of severe allergic conjunctivitis (AC).
The multicenter, double-blind, randomized, vehicle-controlled Phase 3 clinical trial evaluated the safety and efficacy of isunakinra in 258 patients with moderate to severe allergic conjunctivitis for up to 4 weeks. The study found no statistically significant differences between the isunakinra-treated group and the vehicle control group on the primary endpoint of ocular itching, or on any secondary endpoints. Isunakinra was shown to have a tolerable safety profile with no serious adverse events reported.
Isunakinra, a recombinant protein, is the first IL-1 signaling inhibitor designed for topical ophthalmic administration to treat ocular surface inflammatory diseases.
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