China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) subsidiary, Zhaoke Ophthalmology Ltd (HKG: 6622), has announced that the US FDA has accepted for review the New Drug Application (NDA) for Vyluma Inc.’s NVK002, an atropine external use eye solution for pediatric myopia. The FDA has set a Prescription Drug User Fee Act (PDUFA) date for January 31, 2024.
Supporting Data from the Global Phase III CHAMP Study
The filing is supported by positive results from the global Phase III CHAMP study, which evaluated the effects of NVK002 in nearly 600 children over 36 months. The 0.01% NVK002 dose group demonstrated significant statistical and clinical differences compared to placebo in all key results measurements, including responder analysis and the average equivalent spherical degree (SER) and axial length compared with the baseline. NVK002 showed strong safety and tolerability, with no reports of serious adverse events in the eyes, compared to placebo.
NVK-002: A Promising Treatment for Pediatric Myopia
NVK-002 is a preservative-free investigative eye drop product designed to arrest the progression of myopia in children aged 3 to 17 and is administered nocturnally. Zhaoke struck a licensing deal with US firm Nevakar Inc. for NVK-002 in Greater China, South Korea, and Southeast Asia, and in March 2023, granted exclusive South Korean rights to South Korea firm Kwangdong Pharmaceutical Co., Ltd. via another licensing deal.-Fineline Info & Tech
