CLOUDBREAK-B (02592) announced that on May 21, 2026, the group submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for CBT-358. CBT-358 is the most recent addition to the group's product pipeline and a candidate drug from the semi-fluorinated alkane (SFA+) technology platform, intended for the treatment of dry eye disease, a global market valued at tens of billions of dollars.
Dry eye disease, medically known as keratoconjunctivitis sicca, is a complex, multifactorial dysfunction of the ocular surface's "life support system." The core issue involves an imbalance in the tear film, the delicate fluid layer essential for clear vision and corneal comfort. The condition typically arises from either insufficient tear production, excessive tear evaporation, or a combination of both, leading to ocular surface damage and inflammation. Common symptoms for patients include a sensation of foreign bodies or burning in the eyes, blurred vision, and sometimes paradoxical excessive tearing. Dry eye disease ranks among the most frequent reasons for visits to ophthalmologists.
The proposed investigational product, CBT-358, is a novel non-aqueous ophthalmic solution formulation designed to treat aqueous deficiency. Unlike traditional passive lubricants, this formulation utilizes a physiological "cooling" reflex to stimulate endogenous tear production. This activation mimics the effect of low temperatures, triggering a reflex arc that increases basal tear secretion and blink frequency, thereby naturally restoring moisture to the ocular surface. Consequently, CBT-358 is expected to address the tear deficiency associated with dry eye disease.
Simultaneously, this novel non-aqueous formulation employs SFA+ technology and has yielded a serendipitous discovery: in vitro studies and in vivo animal models suggest that CBT-358 may also minimize tear evaporation. Therefore, CBT-358 has the potential to concurrently address both aqueous-deficient and evaporative dry eye, the two fundamental underlying causes for the majority of dry eye cases.
Based on this highly promising breakthrough, the company has accelerated the development process for CBT-358 and successfully completed the studies supporting the IND application ahead of schedule. The submission of the IND application marks the first step in initiating the FDA's drug review process and obtaining regulatory approval to commence clinical trials for CBT-358.
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