Vyluma Announces Marketing Authorization Application Validation for the European Union

Vyluma, Inc. recently announced the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for its lead compound, NVK002. The application is confirmed to be eligible for a Paediatric Use Marketing Authorisation (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 US, China, and the European Union,” said 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 3 CHAMP (Childhood Atropine Myopia Progression) clinical study which evaluated the safety and efficacy of the product in children aged three years and older.

Pediatric myopia can start as early as three to four years old and is progressive in the early years of life. It can affect quality of life and lead to serious eye conditions such as glaucoma, retinal detachment and maculopathy later in life. Myopia adversely impacts the vision of 30% of the world’s population today and is expected to impact an estimated 5 billion people by 2050. Currently, there are no FDA-approved, nor EMA-approved pharmaceutical treatments for myopia available in the US or the EU.

Vyluma is a development-stage biopharmaceutical company with a focus on pharmaceutical treatments for refractive errors of the eye. Vyluma’s pipeline of therapies is led by NVK002, an investigational, preservative-free, low-dose atropine eye drop to treat the progression of myopia in children aged 3 years and older. Vyluma has a robust pipeline of other assets in various stages of development which address important unmet treatment needs of patients with refractive errors or eye pain. Vyluma itself is a subsidiary of Nevakar Inc., a holding company whose subsidiaries are engaged in developing products for the ophthalmic and injectable markets. For more information, visit www.vyluma.com.

Nevakar Inc. is a fully integrated privately held, late-stage biopharmaceutical company with an extensive portfolio of products in the ophthalmic and injectable areas. Founded in 2015, and headquartered in Bridgewater, NJ, the company is focused on developing and commercializing innovative products to address unmet medical needs, thereby improving patients’ quality of life and healthcare outcomes. Nevakar utilizes the US 505(b)(2) regulatory pathway, along with its proven expertise in the development of novel and proprietary sterile pharmaceutical products to identify, develop, and obtain regulatory approval for its products. For more information, visit www.nevakar.com.