China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622) announced that its partner Vyluma Inc. has published the primary results of the Phase III CHAMP study. The results indicate that NVK-002, a potential treatment for myopia in children, has demonstrated strong safety and efficacy.
NVK-002: Drug Profile and Licensing Deal
NVK-002 is a preservative-free eye drop product designed to arrest the progression of myopia in children aged 3 to 17. The product is administered nocturnally. In October 2020, Lee’s Pharma struck a licensing deal with US firm Nevakar Inc., securing exclusive development, manufacturing, and commercialization rights to NVK-002 in Greater China, South Korea, and Southeast Asia. The first patient enrollment for the CHAMP study was completed on November 12, 2020.
Phase III CHAMP Study Results
The study results show that NVK-002 with an atropine concentration of 0.01% had statistically significant and clinically significant differences compared to the placebo in all key outcome indicators. These indicators include responder analysis, baseline average change of spherical lens power, and baseline average change of axial length over the 36-month period. NVK-002 with an atropine concentration of 0.02% also demonstrated effectiveness at multiple time points, including statistical significance in the average change in axial length compared to the placebo at the 36-month mark. At 36 months, there was no statistical significance in the responder analysis. Vyluma (a subsidiary of Nevakar) expects to file the drug for market approval with the US FDA in Q1 2023.
China Clinical Studies and Future Plans
In China, Zhaoke is conducting a two-year Phase III study and a one-year Phase III bridging study concurrently. The CHAMP and small CHAMP studies in China completed patient enrollment on July 21 and 28, 2022, respectively. The company plans to file the drug for marketing in China, combining the small CHAMP results with Phase III CHAMP study data from Vyluma, following US approval.-Fineline Info & Tech
