We are proud to announce that
- CBT-009, our novel ophthalmic formulation of atropine indicated for the treatment of juvenile myopia, has reached agreement with FDA to enter into Phase 3 clinical trial in the USA.
- We have submitted our application to FDA for conducting a Phase 2 clinical trial in the United States to test a first-in-class drug candidate, CBT-004 for the treatment of vascularised pinguecula.
CBT-009 has reached agreement with FDA to enter into Phase 3 clinical trials in the USA.
On 21 September 2023, CBT-009, Cloudbreak received positive feedback from the FDA in response to their proposal for pivotal Phase 3 clinical trials in the United States for one of their core products, a potential best-in-class drug for the treatment of juvenile myopia.
Globally, the patient population of juvenile myopia (i.e. myopia in the patient population aged between 5 and 19 years of age) reached 571.4 million in 2022, with a CAGR of 3.1% from 2018 to 2022. It is estimated to reach 642.2 million in 2027 and 690.7 million in 2032, respectively. The patient population of juvenile myopia in the United States reached 28.7 million in 2022, with a CAGR of 1.0% from 2018 to 2022 and is estimated to reach 29.6 million in 2027.
Atropine is the only pharmacological treatment option that has been demonstrated to be consistently effective in slowing myopic progression and is the only anticholinergic that is recommended in the Guidelines for Appropriate Techniques for the Prevention and Control of Myopia in Children and Adolescents（《兒童青少年近視防控適宜技術指南》）in China. Currently, aqueous atropine eye drops are used in some countries to treat patients with myopia, but the limited shelf life due to atropine’s instability in the aqueous formulation has prevented these eye drops from being widely recognized as a treatment option. Thus, the instability of low-dose atropine eye drops has long been a technical obstacle to commercialization. Furthermore, aqueous atropine eye drops are unstable and easily decomposed into belladonna, tropinic acid, or other substances that greatly affect the efficacy and safety of these eye drops. In addition, preservatives are commonly used in aqueous atropine eye drops to solve the issue of microbial growth, which can be promoted by the buffering agent. Alternative approaches include preservative-free formulations, single-use packaging, or filtering systems, but these incur more costs.
As a non-aqueous atropine eye drop, CBT-009 differs from aqueous atropine. Firstly, non-aqueous atropine eye drops have higher stability as their non-aqueous solutions are without free hydroxide ions, which can (i) significantly reduce the degradation of atropine and thus results in a decrease in the production of impurities, and (ii) prevent the growth of microbes, so no preservatives or single dose-packaging will be needed. Secondly, non-aqueous atropine eye drops require a lower dosage than aqueous eye drops, which can reduce the risks of adverse effects. Thirdly, non-aqueous atropine has higher bioavailability, thereby requiring a lower volume eye drop. This leads to low surface tension and increases the drug’s residence time on the ocular surface.
As one of Cloudbreak’s core products, CBT-009, a non-aqueous, preservative-free, multi-dose packaged eye drop, is expected to significantly enhance patient tolerability, safety, compliance, and product stability. Obtaining regulatory authority agreement to commence pivotal Phase 3 clinical trials in the United States is an important milestone towards the commercialization of CBT-009, the second independently developed product by Cloudbreak to enter Phase 3 clinical trials in the United States, following CBT-001 for the treatment of pterygium.
CBT-004 has submitted our application to FDA for conducting a Phase 2 clinical trial in the United States.
CBT-004, a potential first-in-class drug candidate for the treatment of vascularised pinguecula, has applied for Phase 2 clinical trials to the FDA on September 29, 2023. CBT-004 is a multi-kinase inhibitor that has shown good effectiveness and safety in non-clinical animal disease models and animal toxicological tests. According to the F&S Report, there is currently no approved drug therapy for the treatment of vascularised pinguecula globally. Globally, the patient population of vascularised pinguecula reached 1,149.6 million in 2022, with a CAGR of 1.2% from 2018 to 2022. It is estimated to reach 1,217.1 million in 2027 and 1,283.8 million in 2032, respectively, representing a CAGR of 1.1% from 2022 to 2027 and 1.1% from 2027 to 2032, respectively.
