Cloudbreak Pharma Inc. announced that its wholly-owned subsidiary, ADS Therapeutics LLC, has received confirmation from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug $(IND)$ application for CBT-199, a potential ophthalmic treatment for presbyopia, has become effective. The FDA did not issue any clinical hold, allowing the clinical trial to proceed. This regulatory development authorizes Cloudbreak Pharma Inc. to initiate Phase 2 clinical trials of CBT-199 in the United States. The company stated that it will continue to monitor the evaluation process and provide updates as appropriate.

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