— Prescription Drug User Fee Act (PDUFA) goal date of January 31, 2024 —
Bridgewater, NJ – October 11, 2023 – Vyluma, Inc. (“Vyluma”), a biopharmaceutical company developing multiple assets for the treatment of refractive errors, announced today positive top-line results from the second stage of its Phase III CHAMP (Childhood Atropine for Myopia Progression) clinical study of its lead compound, NVK002 (low dose atropine 0.01%), a proprietary, investigational, preservative-free eye drop administered nightly and intended for patients ages 3 to 17. Analysis of the results of this multi-center, international study conducted after four years of treatment and follow up, show continued strong safety, the absence of rebound upon washout of the study drug, and continued efficacy for NVK002 as a potential treatment for myopia in children.
“With the completion of the second and final phase of CHAMP, Vyluma continues its progress towards bringing NVK002 forward as an important new, first-in-class pharmaceutical treatment option for children with myopia. The NDA for NVK002 is currently under review with the FDA, and a decision is expected in January 2024,” stated Founder & Chairman, Navneet Puri PhD.
During the fourth year of the study, both doses of NVK002 — the 0.01% and 0.02% concentrations — continued to exhibit a strong safety profile with a low level (8% incidence) of Treatment Emergent Adverse Events (TAES) and no evidence of meaningful rebound in subjects who had discontinued active treatment and were washed out over one year. In year four, NVK002 0.01% data indicate a continued widening of the previously reported treatment effect1 in both the mean change from baseline in Spherical Equivalent Refraction (SER), and mean change from baseline in axial length endpoints when compared to a matched historical placebo group. There was no evidence of tachyphylaxis in the treatment effect after four years.
In June 2023 Vyluma announced that the U.S. Food and Drug Administration (FDA) had accepted for review the New Drug Application (NDA) for NVK002. A Prescription Drug User Fee Act (PDUFA) goal date of January 31, 2024, has been assigned by FDA.
About Pediatric Myopia
Pediatric myopia is a common, progressive eye disease that can cause visual impairment, affect quality of life, and lead to serious eye conditions later in life such as glaucoma, retinal detachment and myopic maculopathy. Myopia adversely impacts the vision of approximately 30% of the world’s population today and is expected to impact an estimated 5 billion people by 2050.2,3 Currently, there are no FDA-approved pharmaceutical treatments for myopia available in the U.S.
About Vyluma, Inc.
Vyluma is a development-stage biopharmaceutical company with a focus on pharmaceutical treatments for refractive errors of the eye. Vyluma has a robust pipeline of assets in various stages of development which address important unmet treatment needs of patients with refractive errors or eye pain. Vyluma is a subsidiary of Nevakar Inc., a holding company whose subsidiaries are also engaged in developing products for the injectable markets. For additional information regarding NVK002 or Vyluma please visit www.vyluma.com.
About Nevakar Inc.
Nevakar Inc. is a fully integrated privately held, commercial-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 utilizes the 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.
Lisa M. Wilson
In-Site Communications, Inc.
Raul A. Trillo, MD, MBA
President & Chief Commercial Officer