Cloudbreak Pharma Inc. is pleased to announce that our pipeline CBT-001, the global innovative ophthalmic drug for the treatment of pterygium has recently completed the enrollment of all patients in global centers in its international multicenter Phase III clinical trial. This study is a randomized, double-blind, placebo-controlled Phase III clinical trial, planning to enroll 660 patients aged 12 years and above with pterygium and conjunctival congestion, and aiming to evaluate the safety and efficacy of CBT-001 eye drops in reducing conjunctival congestion and preventing the progression of pterygium.
Developed by Cloudbreak Pharma Inc., CBT-001 is an improvement from an existing drug Nintedanib, the main ingredient of OFEV, which is used for the treatment of angiogenesis and tissues fibrosis. It inhibits neovascularization and tissue fibrosis. Previously, it has completed Phase II clinical trials in the United States and shows high safety and clinical efficacy. It can inhibit the growth of pterygium and control the condition. It can apply to different stages of pterygium and prevent relapse after surgery. Grand Pharmaceutical Group Limited has the exclusive production (including technology transfer) and commercialization rights of CBT-001 in Mainland China, Hong Kong SAR of China, Macao SAR of China, and Taiwan region of China, and the scope of authorization covers the investigational indications of CBT-001, namely, prevention of pterygium growth and reduction of conjunctival congestion. Cloudbreak Pharma Inc. also has a licensing agreement for CBT-001 with Santen Pharmaceutical Co., Limited. Under the terms and conditions of this agreement, Cloudbreak grants rights of CBT-001 to Santen to develop, manufacture and commercialize the drug products in Japan, South Korea, and Southeast Asian countries of Vietnam, Thailand, Malaysia, Philippines, Singapore and Indonesia.
Pterygium is a common chronic inflammation and proliferative ocular surface disease. It is always found at corner conjunctiva and may gradually affect cornea, lead to astigmatism or cover the pupil and result diminution of vision or even blind. According to the World report on vision released by the World Health Organization, the global prevalence of pterygium is 10.2%, and it is as high as 33% in rural areas of China. According to relevant literature, the prevalence of people aged 40 and above in China is 13.4%, and it continues to increase with age. Currently there is no specified drugs for treatment of pterygium. Practically it is treated by means of artificial tear, or off-label drugs like nonsteroidal or glucocorticoid eye drops. However, those existing drugs did not show concrete effectiveness and have safety risk after long-term usage. Severe cases can be treated with surgery, but the recurrence rate after sclerectomy for pterygium is 30-80%, and multi-times recurrence may cause blepharoplasty and affect the movement of eyeball. This shows that the treatment of pterygium has huge unsatisfied clinical requirement.
As the Phase III clinical trial completes full patient enrollment, CBT-001 has taken a crucial step toward becoming the world’s first dedicated treatment for pterygium. Cloudbreak Pharma will continue to closely monitor the trial’s progress to ensure smooth advancement of the study. We look forward to the completion of this innovative therapy’s clinical trials, bringing a safe and effective treatment option to hundreds of millions of pterygium patients worldwide and addressing this significant unmet medical need. Through our strategic partnerships with Grand Pharmaceutical Group and Santen Pharmaceutical, we are well-positioned to deliver this innovative achievement to patients across the Asia-Pacific region, making a positive contribution to improving global eye health.
