Zhaoke Ophthalmology Initiates Phase 3 Clinical Trial of Atropine Sulfate Eye Drops (NVK-002) in China with 526 Pediatric Participants

On February 17, the China Drug Clinical Trial Registration and Information Disclosure Platform showed that Zhaoke Ophthalmology Limited has initiated a Phase 3 clinical trial of atropine sulfate ophthalmic solution (NVK-002) for slowing the progression of myopia in children, planning to enroll 526 patients in China. Public information indicates that NVK-002 was introduced to Zhaoke Ophthalmology by Nevakar, Inc., and has entered the Phase 3 clinical trial stage globally.

Source of Screenshot: Drug Clinical Trial Registration and Information Disclosure Platform

Myopia has become one of the public health issues globally. Research indicates that the progression of myopia in children may be related to accommodative fatigue. For the prevention and control of myopia in children and adolescents, low-concentration atropine has been recognized as a consistently effective medication. Atropine is an anticholinergic drug that can block the action of neurotransmitters in both the central and peripheral nervous systems, controlling the progression of myopia by inhibiting the accommodation mechanism.

However, the instability of low-concentration atropine poses a long-standing drug development challenge for such medications. Therefore, researchers are developing new types of atropine drugs in the hope of ensuring safety, efficacy, and compliance while also reducing the degradation rate of low-concentration atropine, thereby enabling long-term storage.

NVK-002 is a sterile, preservative-free, low-concentration atropine eye drop developed by Nevakar, Inc. for the intended use of controlling myopia progression in children and adolescents. In October 2020, Zhaoke Ophthalmology Limited entered into a collaboration with Nevakar, Inc., obtaining exclusive development and commercialization rights for NVK-002 in Greater China, South Korea, and several Southeast Asian countries and regions.

According to the data previously released by Zhaoke Ophthalmology, the proprietary formulation of NVK-002 has successfully addressed the instability issues of low-concentration atropine, with an expected shelf life of at least 24 months. Moreover, since NVK-002 is preservative-free, it can avoid side effects such as irritation and certain ocular surface diseases caused by preservatives.

Currently, Nevakar is conducting a Phase 3 clinical trial named CHAMP in the United States and Europe to evaluate the efficacy and safety of NVK-002 in controlling myopia progression in children and adolescents. According to the preliminary safety report of the CHAMP clinical trial released by Zhaoke Ophthalmology, NVK-002 was well-tolerated with no new significant safety issues identified.

According to the Chinese Clinical Trials Registry and Information Disclosure Platform, Zhaoke Ophthalmology has initiated a randomized, double-blind, placebo-controlled, parallel-group, multi-center Phase 3 clinical trial named Mini-CHAMP in China. This trial aims to evaluate the efficacy and safety of two low-concentration atropine sulfate eye drops (0.01% and 0.02%) for slowing the progression of myopia in children. The primary endpoint is the intergroup difference in the proportion of subjects with myopia progression (SER) less than -0.50D at the M12 (12 months of treatment) visit for 0.02% atropine compared to placebo. The study will be conducted across 18 clinical trial centers in China, with plans to enroll 526 patients.

Notably, Zaoke Ophthalmology had previously launched another Phase 3 clinical trial in China, named China-CHAMP, to evaluate the efficacy and safety of two low-concentration atropine sulfate eye drops (0.01% and 0.02%) compared to a placebo for slowing the progression of myopia in children. The primary endpoint of this trial is: the intergroup difference in the change from baseline in computerized cycloplegic refraction spherical equivalent at the M24 visit (after 24 months of treatment) for 0.02% atropine versus placebo. This study plans to enroll 770 patients in China and is currently ongoing.

We hope that the subsequent clinical research of this Atropine Sulfate Eye Drops proceeds smoothly and achieves good results, bringing new options to patients as soon as possible.

References:

[1] China Drug Clinical Trial Registration and Information Disclosure Platform. Retrieved Feb 17, 2022, from http://www.chinadrugtrials.org.cn/clinicaltrials.searchlistdetail.dhtml

[2] Zhaoke Ophthalmology Limited Prospectus. Retrieved Apr 27, 2021, from https://www1.hkexnews.hk/listedco/listconews/sehk/2021/0416/2021041600010_c.pdf

▽Follow 【WuXi AppTecGermany】WeChat Official Account