Vyluma Announces Marketing Authorization Application Validation for the European Union

2024-05-29

临床3期临床结果

BRIDGEWATER, N.J., May 29, 2024 (GLOBE NEWSWIRE) -- Vyluma, Inc. (“Vyluma”), a biopharmaceutical company dedicated to advancing novel ophthalmic solutions for refractive errors, announced today that 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 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 three years and older.

About Pediatric Myopia

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 2050.1,2 Currently, there are no FDA-approved, nor EMA-approved pharmaceutical treatments for myopia available in the U.S. or the E.U.

About Vyluma, Inc.

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 additional information please visit www.vyluma.com.

About Nevakar Inc.Nevakar Inc.

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, New Jersey, 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 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. Additional information is available at www.nevakar.com.

Investor Contact for Vyluma

Investor Contact:

Raul A. Trillo, MD, MBA

President & Chief Commercial Officer

rtrillo@vyluma.com

References:

Holden, B. A., Fricke, T. R., Wilson, D. A., Jong, M., Naidoo, K. S., Sankaridurg, P., Wong, T. Y., Naduvilath, T. J., & Resnikoff, S. (2016). Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology, 123(5), 1036–1042.

Sankaridurg, P., Tahhan, N., Kandel, H., Naduvilath, T., Zou, H., Frick, K. D., Marmamula, S., Friedman, D. S., Lamoureux, E., Keeffe, J., Walline, J. J., Fricke, T. R., Kovai, V., & Resnikoff, S. (2021). IMI Impact of Myopia. Investigative Ophthalmology & Visual Science, 62(5).

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机构

Vyluma, Inc.