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FDA Accepts NDA for Low-Dose Atropine Eye Drops for Pediatric Myopia Treatment
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Vyluma Inc. announced that the FDA will review its new drug application for NVK002, a preservative-free low-dose atropine eye drop for myopia in children ages 3 to 17 years.
“The FDA approval of our NDA is a major milestone for Vyluma and brings us another step closer to advancing NVK002 as a new first-in-class treatment option for myopic children.” Dr. Navneet Puri, Vyluma’s founder and chairman said in the company’s press release: “NVK002 has been extensively clinically tested and adheres to the high quality standards expected of a pharmaceutical manufactured product. I look forward to continuing.”
NDA Announces Positive Results from Global Phase 3 Clinical Trial of Pediatric Atropine for Myopia Progression Evaluating the Safety and Efficacy of NVK002 vs. Placebo in Approximately 600 Children It is said to be backed by
Statistically significant and clinically meaningful mean change from baseline in spherical equivalent refraction and axial length at 36 months when the investigational eye drops were administered nightly at a dose of 0.01%, according to the company A difference was obtained, and no serious ocular adverse events were reported.
FDA has assigned a target date of January 31, 2024 for the Prescription Drug User Fees Act.
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