Cloudbreak Receives U.S. Food and Drug Administration Clearance to Proceed with Clinical Study using Investigational New Drug CBT-006

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Irvine, CA – November 30, 2020 – Cloudbreak Therapeutics, a clinical-stage company focused on developing innovative therapies for diseases and conditions of the eye, had received clearance from the U.S. Food and Drug Administration (FDA) to proceed with a Phase 2 study using Investigational New Drug (IND) CBT-006 to treat Meibomian Gland Dysfunction Associated Dry Eye Disease.

The Phase 2 clinical trial is a U.S.-based, randomized, double-masked, multi-center trial evaluating the safety, tolerability and efficacy of 2.5% and 10% CBT-006 in comparison of vehicle when instilled three times a day (TID) dosing for 3 months in patients with MGD-DED.