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Vyluma Receives EU Marketing Application Authorization for Low-Dose Atropine NVK002

May 29, 2024


Photo Credit: Moment, Getty Images

BRIDGEWATER, N.J. — Vyluma announced it has received approval from the European Medicines Agency (EMA) of its Marketing Authorization Application (MAA) for its low-dose atropine solution NVK002. The application is confirmed to be eligible for a Pediatric Use Marketing Authorization (PUMA), providing 10 years of data exclusivity and marketing protection upon product approval.

“This acceptance represents an important and key milestone for our company, as NVK002 has now been submitted for regulatory review across our three most key global markets: the U.S., China, and the European Union,” stated Raul A. Trillo, MD, MBA, President, and Chief Commercial Officer of Vyluma. “Our steadfast commitment to delivering an innovative pharmaceutical option for pediatric myopia underscores our dedication to improving children’s vision worldwide.”

The regulatory application of NVK002 is supported by previously reported safety and efficacy data from the multi-center, placebo-controlled, Phase III CHAMP (Childhood Atropine Myopia Progression) clinical study, which evaluated the safety and efficacy of the product in children aged 3 years and older.

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