Zhaoke Ophthalmology Atropine Sulfate Eye Drops Starts Phase 3 Clinical Trial in China and Plans to Enroll 526 People

On February 17, the China Drug Clinical Trial Registration and Information Publicity Platform showed that Zhaoke Ophthalmology Co.

Screenshot source: Drug Clinical Trial Registration and Information Publicity Platform

Myopia has become one of the global public health problems

However, low concentrations of atropine suffer from instability, a longstanding drug development challenge for this class of drugs

NVK-002 is a sterile, preservative-free, low-concentration atropine eye drop developed by Nevakar for the control of myopia progression in children and adolescents

According to the information previously released by Zhaoke Ophthalmology, the proprietary dosage form of NVK-002 successfully solved the instability problem of low-concentration atropine, and the expected validity period is at least 24 months

Currently, Nevakar is conducting a Phase 3 clinical trial called CHAMP in the United States and Europe to evaluate the efficacy and safety of NVK-002 in controlling the progression of myopia in children and adolescents

According to the China Drug Clinical Trial Registration and Information Publicity Platform, Zhaoke Ophthalmology has launched a randomized, double-blind, placebo-controlled, multi-center Phase 3 clinical trial called Mini-CHAMP in China.

It is worth mentioning that Zhaoke Eye has previously launched another Phase 3 clinical trial in China called China-CHAMP to evaluate two low-concentration atropine sulfate eye drops (0.

It is hoped that the follow-up clinical study of this atropine sulfate eye drops will proceed smoothly, achieve good results, and bring new choices to patients as soon as possible

References:

[1] China Drug Clinical Trial Registration and Information Publicity Platform.