Our global innovative ophthalmic drug CBT-001 (GPN00153) 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. The enrollment of all patients in the clinical study of the product this time is another major milestone in the ophthalmology direction of the Group in the field of ENT.
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.
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 Pharma 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.
