Cloudbreak Pharma Inc. (Stock Code: 2592) released a voluntary announcement stating that the investigational new drug (IND) application for CBT-199, filed on 12 December 2025 with the United States Food and Drug Administration (FDA), has become effective with no clinical hold imposed. This status confers Safe-to-Proceed clearance, allowing the commencement of Phase 2 clinical trials.

According to the announcement, CBT-199 is a novel topical ophthalmic emulsion intended for the treatment of presbyopia. It contains a parasympathomimetic miotic agent formulated in a non-aqueous platform designed to create a pinhole effect through pupil constriction, improving near vision. The water-free formulation aims to enhance stability of the active ingredient and support a consumer-friendly multi-dose presentation with a long shelf life. Pre-clinical animal studies began in 2023 to evaluate its safety and tolerability.

The announcement reiterates that there is no guarantee CBT-199 or any other candidate will be successfully developed or commercialized. Caution is advised when dealing in the shares of Cloudbreak Pharma Inc.