Cloudbreak Pharma Gets FDA Clearance for Presbyopia Drug CBT-199 Phase 2 Trial
FDA clears Cloudbreak Pharma's IND for CBT-199, a novel presbyopia eye drop, allowing Phase 2 trials to proceed. The company also advances CBT-001 (Phase 3 for pterygium) and CBT-004 (Phase 3 for pinguecula).
Cloudbreak Pharma has announced that the U.S. Food and Drug Administration has completed its safety review of the Investigational New Drug application for its ophthalmic drug CBT-199 without imposing a clinical hold, clearing the company to proceed with the proposed clinical study. The decision renders the application effective and designates the program as Safe-to-Proceed in the United States, with the drug now transitioning into Phase 2 clinical trials.
CBT-199 is a novel topical ophthalmic emulsion for presbyopia that employs a parasympathomimetic miotic agent in a proprietary non-aqueous formulation to improve near vision through a pinhole effect and enhanced drug stability. The company began discovery work on CBT-199 in China in 2023 and has since generated pre-clinical animal safety and tolerability data to support human testing.
Cloudbreak Pharma is a clinical-stage ophthalmic drug developer focused on innovative topical therapies for age-related eye conditions. Through its U.S. subsidiary ADS Therapeutics LLC, the group is advancing CBT-199, leveraging a proprietary water-free platform designed to enhance stability and patient comfort.
Beyond CBT-199, Cloudbreak's lead asset is the eye drop CBT-001, currently in mid-Phase 3 as a potential treatment for pterygium, a disease impacting 15 million people in the U.S. alone. Initial topline data for CBT-001 is anticipated in the Third Quarter of 2026. The company's second asset, the eye drop CBT-004, is entering Phase 3 as a potential disease-modifying treatment for pinguecula, which is estimated to impact 50 million people in the U.S. alone. There are currently no FDA-approved disease-modifying treatments for either pterygium or pinguecula.