FDA accepts NDA for low-dose atropine eye drop to treat pediatric myopia
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Vyluma Inc. has announced that the FDA will review its new drug application for NVK002, a preservative-free, low-dose atropine eye drop for myopia in children aged 3 to 17 years.
“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,” Navneet Puri, PhD, founder and chairman of Vyluma, said in a company press release. “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.”
According to the release, the NDA is backed by positive results from the global, phase 3 Childhood Atropine for Myopia Progression clinical study, which assessed the safety and efficacy of NVK002 vs. placebo in approximately 600 children.
When administered nightly at a dose of 0.01%, the investigational eye drop achieved statistically significant and clinically meaningful differences in mean change from baseline in spherical equivalent refraction and axial length at month 36, the company said, with no reports of serious ocular adverse events.
The FDA has assigned a Prescription Drug User Fee Act goal date of Jan. 31, 2024.
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