Second Drug for Zhaoke to reach Primary Endpoint in Phase III Clinical Trial in One Month
Potential First-To-Market Generic Levobetaxolol Targeting Glaucoma in China
Targeting NDA Filing by First Half of 2022
Market Size of Glaucoma Drugs in China Expanding at 25.4% CAGR to US$2 billion by 2030
HONG KONG, 2 September 2021 – Zhaoke Ophthalmology Limited (“Zhaoke Ophthalmology” or the “Company”, SEHK: 6622), a leading ophthalmic pharmaceutical company dedicated to the research, development and commercialization of therapies that address significant unmet medical needs, is pleased to announce a second drug that has met its primary endpoint in a Phase III clinical trial in a month. One of the Company’s generic drug candidates, Levobetaxolol Hydrochloride (HCl) Eye Drops for the treatment of intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension, has met its primary endpoint in decreasing IOP in eight weeks compared to the baseline.
Analysis of the results show that the patient group who received Levobetaxolol Hydrochloride (HCl) Eye Drops demonstrated statistically significant (P<0.01) superior efficacy after eight weeks of treatment, when compared to the patient group receiving the comparator treatment, Betaxolol HCl ((BETOPTIC®S) Detailed results are expected to be announced at an upcoming medical meeting after the comprehensive statistical analysis is completed.
Zhaoke Ophthalmology plans to submit a new drug application (NDA) to the National Medical Products Administration (NMPA) by the first half of 2022, with the aim to receive approval in 2023 and to manufacture the product in-house after regulatory approval.
Levobetaxolol Hydrochloride (HCl) Eye Drops is a generic to Betaxolol HCl Eye Drops being developed by Zhaoke Ophthalmology in China for the treatment of IOP in patients with primary open-angle glaucoma or ocular hypertension. It is potentially the first-to-market generic of levobetaxolol targeting glaucoma in China. This new formulation has been shown to be more effective and better tolerated than the original treatment.
Glaucoma is a chronic and progressive disease associated with high IOP, resulting in optic nerve damage. It is the second largest cause of blindness worldwide, and a rapidly growing disease in China, driven by the aging population. According to China Insights Consultancy, the market size of glaucoma drugs in China is expected to rapidly grow from US$162.7 million in 2019 to US$2.0 billion in 2030, at a compound annual growth rate of 25.4%.
Dr. Li Xiaoyi (Benjamin), Chairman and CEO of Zhaoke Ophthalmology, commented, “The results of the Zhaoke Ophthalmology’s Levobetaxolol Hydrochloride (HCl) Eye Drops Phase III clinical trial mark another significant milestone for our research and development team. Glaucoma affects more than 15.3 million people in China alone. We hope to bring this drug to market as soon as possible, given it has been shown to be more effective and better tolerated than existing treatments, benefiting Chinese patients affected by the disease. I am excited by the momentum we have at Zhaoke currently, two drugs reaching their endpoints in Phase III clinical trials in one month, is a fabulous result for our R&D team. In addition, Levobetaxolol Hydrochloride Eye Drops will become the third product in our glaucoma franchise to reach NDA/ANDA filing stage in China, further strengthening our overall position in this important and underserved disease area.”
About Levobetaxolol Hydrochloride (HCl) Eye Drops
Levobetaxolol Hydrochloride (HCl) Eye Drops is a generic to Betaxolol HCl Eye Drops. The former contains only the levo enantiomer while the latter is a racemic mixture of both the levo and dextro forms. The levo enantiomer has been shown to be more potent and selective than the dextro form for the b1 adrenergic receptor and is thus more efficacious and better tolerated than the racemic mixture for the treatment of glaucoma. Topline results of the Phase III clinical trials show statistically significant (P<0.01) superior efficacy after eight weeks of treatment. An NDA submission is expected by the first half of 2022.
About the Phase III Clinical Trial of Levobetaxolol Hydrochloride (HCl) Eye Drops
The Multicenter, Randomized, Openlabel, Positive-controlled, Parallel-group and Superiority Clinical Trial of Levobetaxolol Hydrochloride Eye Drops compared with Betaxolol Hydrochloride Eye Drops conducted in China aims to evaluate the efficacy and safety of the treatment in patients with Primary Open-angle Glaucoma or Ocular Hypertension. The trial enrolled a total of 366 patients, randomized in a 1:1 ratio between the levobetaxolol HCl eye drops group, and the Betaxolol Hydrochloride eye drops group.
