Cloudbreak Pharma's Novel Myopia Drug CBT-009 Receives FDA Phase 3 Clearance

Oct 08, 2023 17:13 CST Updated 17:14

Cloudbreak Pharma

Ophthalmic New Drug Developer

▎Edited by the WuXi AppTec content team

1October 7,Cloudbreak Pharma (Cloudbreak Pharma) released a press release stating that several of its self-developed new drugs have recently achieved positive clinical progress in the United States. Among them, the drug used forNew Drug CBT-009 for Treating Adolescent Myopia Granted Phase 3 Clinical Trial Approval, forNew Drug CBT-004 for Treating Congestive Macular Edema Submits Phase 2 Clinical Trial Application。

Among them, CBT-009 eye drops areA Novel Non-Aqueous Atropine Eye Drop, compared with existing aqueous atropine eye drops,The stability of the formulation has been significantly improved, which can markedly reduce the degradation of atropine, thereby decreasing the generation of impurities., which also allows CBT-009 to be stored for a long time at room temperature or even high temperatures. CBT-009 Eye DropsHas the inherent ability to prevent bacterial growthTherefore, there is no need to add extra preservatives or adopt special single-dose packaging. The required dosage of the non-aqueous atropine eye drops CBT-009 is lower than that of existing aqueous eye drops.Can be evenly distributed in the tear film, thereby increasing the residence time of atropine on the ocular surface and improving bioavailability.Moreover, CBT-009 eye drops function as an ocular comfort solution, offering excellent patient experience and significantly improving treatment adherence among adolescent patients.

According to the press release from Cloudbreak Pharma, CBT-009 eye drops, as one of the company's core products,Preservative-free, water-free, and comfortable multi-dose packaging is expected to significantly improve patient tolerance, safety, compliance, and product stability.Obtaining Phase 3 clinical approval in the United States represents a significant milestone in the commercialization of this drug. It is also the second self-innovated product from Cloudbreak Pharma to be approved for Phase 3 clinical trials in the U.S., following CBT-001, a new drug for treating pterygium.

CBT-004 is a small molecule multi-kinase inhibitor that has demonstrated good efficacy and safety in non-clinical pharmacodynamic animal models and animal toxicology studies.The company submitted a Phase 2 clinical study application to the U.S. FDA on September 29, 2023, for the treatment of congestive macular edema.

Cloudbreak Pharma is a clinical-stage biotechnology company focused on the research and development of novel ophthalmic drugs. Its current R&D pipeline includes various ophthalmic drugs, among which CBT-001, CBT-009, CBT-004, and CBT-006 have entered or are about to enter international multicenter Phase 3 or Phase 2 clinical trials.

References:

[1]Cloudbreak Pharma Achieves Significant Clinical Progress with Multiple Self-Developed New Drugs. Retrieved Oct 7, 2023, From https://mp.weixin.qq.com/s/CrFeCSHxjz4Lciei-bVvNQ

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