FDA acceptance of Vyluma’s NDA for NVK002 is another major milestone towards treating the progression of myopia in children after the recent publication of positive results from its landmark Phase III clinical trial.
Hong Kong – June 7, 2023 – Zhaoke Ophthalmology Limited (“Zhaoke Ophthalmology” or “the Company”, SEHK: 6622), a leading ophthalmic pharmaceutical company dedicated to the research, development, manufacturing and commercialization of treatments that address significant unmet medical needs, is pleased to announce an update from the Company’s partner, Vyluma, Inc. (“Vyluma”), a biopharmaceutical company developing multiple assets for the treatment of refractive errors.
Vyluma announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for its lead compound, NVK002 (low dose atropine 0.01%) as a potential treatment for myopia in children. NVK002 is a proprietary, investigational, preservative-free eye drop administered nightly and intended for patients ages 3 to 17. A Prescription Drug User Fee Act (PDUFA) goal date of January 31, 2024, has been assigned by FDA.
“FDA acceptance of our NDA is a major milestone for Vyluma and brings us one step closer to advancing NVK002 as a new, first-in-class treatment option for children with myopia,” stated Founder & Chairman, Navneet Puri PhD. “NVK002 has been thoroughly tested clinically and adheres to the high-quality standards required of a pharmaceutically manufactured product. We look forward to continuing to collaborate with FDA on the review of this important new treatment.”
Vyluma’s NDA is supported by positive results from its landmark, three-year, placebo-controlled international Phase III CHAMP (Childhood Atropine for Myopia Progression) clinical study, evaluating the safety and efficacy of NVK002 in nearly 600 children. NVK002 at a dose of 0.01% achieved statistically significant and clinically meaningful differences from placebo at month 36 in the key outcome measures of responder analysis, mean change from baseline in Spherical Equivalent Refraction (SER), and mean change from baseline in axial length. NVK002 demonstrated strong safety and tolerability when compared to placebo with no serious ocular adverse events reported.
Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, said, “We are excited by the FDA acceptance of Vyluma’s NDA for NVK002, as well as by the positive results from its Phase III CHAMP clinical study conducted in the US and Europe, which were just published in JAMA Ophthalmology, the well-respected medical journal. Our own NVK002 trials in China are progressing well, with Last Patient Out (LPO) for Mini-CHAMP expected at the end of July this year. The results of both will add to the evidence for the NVK002 NDA submission to the Chinese regulator. Myopia is a global problem, and approximately 700 million patients are currently affected by it in China, according to data from the World Health Organisation and China Insights Consultancy. Today’s news brings us one step closer to addressing this critical unmet need for many children around the world.”
About Pediatric Myopia
Pediatric myopia can start as young as 3 to 4 years and be progressive in the early years of life. It can affect quality of life and lead to serious eye conditions such as glaucoma, retinal detachment and maculopathy. Myopia adversely impacts the vision of 30% of the world’s population today and is expected to impact an estimated 5 billion people by 2050.1,2 Currently, there are no FDA-approved pharmaceutical treatments for myopia available in the U.S.
About Vyluma, Inc.
Vyluma is a development-stage biopharmaceutical company with a focus on pharmaceutical treatments for refractive errors of the eye. Vyluma has a robust pipeline of assets in various stages of development which address important unmet treatment needs of patients with refractive errors or eye pain. Vyluma is a subsidiary of Nevakar Inc., a holding company whose subsidiaries are also engaged in developing products for the injectable markets. For additional information regarding NVK002 or Vyluma please visit www.vyluma.com.
About Nevakar Inc.
Nevakar Inc. is a fully integrated privately held, commercial-stage biopharmaceutical company with an extensive portfolio of products in the ophthalmic and injectable areas. Founded in 2015, and headquartered in Bridgewater, New Jersey, the Company is focused on developing and commercializing innovative products to address unmet medical needs, thereby improving patients’ quality of life and healthcare outcomes. Nevakar utilizes the 505(b)(2) regulatory pathway, along with its proven expertise in the development of novel and proprietary sterile pharmaceutical products to identify, develop, and obtain regulatory approval for its products. Additional information is available at www.nevakar.com.
