Cloudbreak Pharma has announced that the last patient has exited the study of the Phase II clinical trial in the U.S on May 17, 2022 for CBT-006, a new drug for the treatment of dry eye disease caused by meibomian gland dysfunction. The results of the Phase II clinical trial are expected to be officially announced in the third quarter of 2022.
Dry eye disease is a common ocular surface disease worldwide. According to the “Expert Consensus on Clinical Diagnosis and Treatment of Dry Eye”, “the incidence rate of dry eye in China has reached 21%-30%, which is the most common ophthalmic disease after myopia (short-sighted).” There are currently about 360 million dry eye patients in China. The statement “1 in 5 people suffers from dry eye” were once on the trending internet search, raising the public’s awareness to eye health.
Dry eye diseases can broadly be divided into five categories, among which meibomian gland dysfunction (MGD) is one of the main causes of dry eye disease. Meibomian glands secrete complex lipids called meibomian fluid to the ocular surface. These complex lipids form the outer layer of the tear film to prevent water evaporation, keep the tear film stable and the ocular surface moist. Patients with meibomian gland dysfunction are often characterized by obstruction of the terminal ducts of the meibomian glands and/or abnormal glandular secretions, which can lead to tear film instability, eye irritation, inflammation, and dry eye disease. Such ocular discomfort often affects their quality of life. In addition, according to research, the prevalence of MGD in the United States is about 20%, while that in Asia is as high as 60%, of which 72% of patients are over the age of 60. It illustrates that the prevalence of MGD among Asians and middle-aged to elderly group is staggering.
Cloudbreak has developed CBT-006 that utilizes a new mechanism of action for the treatment of this eye disease. CBT-006 unclogs the meibomian glands by dissolving cholesterol in the meibomian fluid, and eliminates inflammation and increases lipid fluidity. CBT-006 is in the form of eye drops and can be applied continuously on the affected area to dissolve cholesterol deposited in the orifice of the meibomian glands to improve the quality of meibomian fluid and the health of meibomian glands, thereby curing dry eye syndrome caused by meibomian gland dysfunction (MGD-DED).
Cloudbreak has completed the Phase II clinical trial (CBT-CS102) for CBT-006 in the treatment of meibomian gland dysfunction-related dry eye diseases in the U.S., and the last patient has successfully exited the study. The Phase II clinical study protocol included 90 subjects instilling CBT-006 three times a day (TID) for three consecutive months to evaluate the safety, tolerability and efficacy of the drug (ClinicalTrials.gov registration number: NCT04884243).