Vyluma's EU Marketing Authorization Application Validated

Vyluma, Inc., a biopharmaceutical company focused on innovative ophthalmic treatments for refractive errors, has announced that the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for its primary compound, NVK002. This application is eligible for a Paediatric Use Marketing Authorisation (PUMA), which provides 10 years of data exclusivity and marketing protection once the product is approved.

Raul A. Trillo, MD, MBA, President and Chief Commercial Officer of Vyluma, highlighted the significance of this milestone, noting that NVK002 is now under regulatory review in the U.S., China, and the European Union. He emphasized Vyluma’s dedication to providing innovative pharmaceutical solutions for pediatric myopia, aiming to enhance children's vision globally.

The application for NVK002 is supported by safety and efficacy data from the Phase III CHAMP (Childhood Atropine Myopia Progression) clinical study. This multi-center, placebo-controlled study assessed the safety and effectiveness of NVK002 in children aged three years and older.

Pediatric myopia, which can begin as early as three to four years old, is a progressive condition in early childhood. It significantly impacts quality of life and can lead to severe eye conditions such as glaucoma, retinal detachment, and maculopathy later in life. Currently, myopia affects 30% of the global population, with projections indicating it could impact 5 billion people by 2050. Despite its prevalence, there are no FDA-approved or EMA-approved pharmaceutical treatments for myopia available in the U.S. or the European Union.

Vyluma, Inc. is a development-stage biopharmaceutical company specializing in treatments for refractive errors of the eye. NVK002, its leading investigational product, is a preservative-free, low-dose atropine eye drop designed to slow the progression of myopia in children aged three years and older. Vyluma’s pipeline includes various other therapies at different stages of development, addressing significant unmet needs in treating refractive errors and eye pain.

Vyluma is a subsidiary of Nevakar Inc., a holding company engaged in developing products for the ophthalmic and injectable markets. Nevakar, Inc., founded in 2015 and headquartered in Bridgewater, New Jersey, is a private, late-stage biopharmaceutical company. It focuses on developing and commercializing innovative products to meet unmet medical needs, enhancing patients' quality of life and healthcare outcomes. Utilizing the US 505(b)(2) regulatory pathway, Nevakar combines its expertise in developing novel and proprietary sterile pharmaceutical products to achieve regulatory approval.

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