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Vyluma's NVK002 Granted FDA Acceptance for New Drug Application to Treat Pediatric Myopia

Wednesday, June 07, 2023

Vyluma, a biopharmaceutical company dedicated to developing treatments for refractive errors, has announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for their lead compound, NVK002. NVK002 is a low-dose atropine eye drop (0.01%) designed as a potential treatment for pediatric myopia. This acceptance is a significant milestone for Vyluma, bringing them closer to offering NVK002 as a novel solution for children with myopia.

The NDA submission for NVK002 includes positive results from the CHAMP (Childhood Atropine for Myopia Progression) clinical study. Over the course of three years, the study involved nearly 600 children and evaluated the safety and efficacy of NVK002. The results demonstrated that NVK002 at a 0.01% dose achieved statistically significant and clinically meaningful differences compared to the placebo. Additionally, NVK002 exhibited a favorable safety profile with no serious ocular adverse events reported.

Vyluma's Founder & Chairman, Navneet Puri, expressed excitement about the FDA acceptance, emphasizing their commitment to developing a high-quality treatment option for pediatric myopia. Vyluma will continue to collaborate with the FDA during the review process to advance NVK002 as an important new treatment.

Pediatric myopia is a condition that can start as early as 3 to 4 years of age and can have a progressive course. It not only affects the quality of life but can also lead to serious eye conditions such as glaucoma, retinal detachment, and maculopathy. With approximately 30% of the global population currently affected by myopia and an estimated 5 billion people projected to be impacted by 2050, there is a significant need for effective pharmaceutical treatments. Presently, there are no FDA-approved pharmaceutical treatments available for myopia in the United States.

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