Low Dose Atropine Eye Drops Under Review for Pediatric Myopia

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for NVK002 (low dose atropine 0.01%) for the treatment of children with myopia.

The application is supported by data from the multicenter, randomized, double-masked, placebo-controlled phase 3 CHAMP study (ClinicalTrials.gov Identifier: NCT03350620), which included nearly 600 children 3 to 17 years of age with myopia. Study participants were randomly assigned to receive NVK-002 or placebo once nightly.

Three-year data showed that NVK002 at a dose of 0.01% achieved statistically significant and clinically meaningful differences compared with placebo for key outcome measures, including responder analysis, mean change from baseline in Spherical Equivalent Refraction, and mean change from baseline in axial length. The most common ocular adverse events reported were hyperemia, photophobia, allergic conjunctivitis, eye pruritus, and eye irritation.

“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,” said Navneet Puri PhD, Founder & Chairman. “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.”

A regulatory decision is expected on January 31, 2024.