Cloudbreak Pharma Inc. (Cloudbreak) has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration on 21 May 2026 for CBT-358, according to a voluntary announcement dated 22 May 2026.

CBT-358 is the newest asset in Cloudbreak’s pipeline and originates from the company’s Semi-fluorinated Alkane (SFA+) technology platform. The candidate targets dry eye disease (DED), identified by the company as a multi-billion-dollar global market.

The investigational product is a novel non-aqueous ophthalmic solution designed to address both aqueous-deficient and evaporative forms of DED. The formulation activates the physiological “cooling” reflex to stimulate endogenous tear production while pre-clinical data suggest it may also reduce tear evaporation.

Cloudbreak reported that IND-enabling studies were completed ahead of schedule, enabling the accelerated filing. FDA acceptance of the IND would allow the company to begin clinical trials in the United States.

Management reiterated that there is no assurance CBT-358 or any other pipeline candidate will ultimately obtain regulatory approval or reach the market. Shareholders and potential investors are advised to exercise caution when dealing in the company’s shares.