Cloudbreak Receives U.S. Food and Drug Administration Clearance to Proceed with Clinical Study using Investigational New Drug CBT-004

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Irvine, CA – February 18, 2021 – 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-004 to treat vascularized pinguecula.

The Phase 2 clinical trial is a U.S.-based, randomized, double-masked, vehicle-controlled, multi-center trial evaluating the safety, tolerability and efficacy of CBT-004 ophthalmic emulsion when instilled twice daily (BID) for 28 days at the proposed doses of 0.01% and 0.024% in patients with vascularized pinguecula.