Xingqi Pharmaceutical announced that the Phase II clinical trial of its SQ-22031 eye drops for the treatment of neurotrophic keratitis has met its primary endpoint. Results showed that the high-dose group demonstrated superior efficacy benefits with a favorable safety profile, supporting the high-dose group as the proposed dose for the Phase III clinical trial. The study was a randomized, double-blind, placebo-controlled, parallel-group Phase II clinical trial designed to evaluate the efficacy and safety of different doses of SQ-22031 eye drops. SQ-22031 eye drops are a Category 1 therapeutic biological product, and as of the announcement date, no similar drug has been approved for marketing in China. The company stated that this clinical study report will not have a significant impact on its near-term performance, and a confirmatory Phase III clinical trial is still required.
Shenyang Xingqi Pharmaceutical Co LtdSQ-22031 eye drops met primary endpoint in Phase II trial for neurotrophic keratitis, a positive clinical development.