Vyluma Discusses FDA Feedback on Atropine Solution for Pediatric Myopia

Vyluma, Inc., a clinical-stage pharmaceutical company specializing in ophthalmic treatments, recently held a Type A meeting with the U.S. Food and Drug Administration’s (FDA’s) Division of Ophthalmology on June 4, 2024. The discussion focused on addressing FDA’s queries about Vyluma's advanced product, Atropine Sulfate Ophthalmic Solution 0.01%, which is under development for treating pediatric myopia. Vyluma expressed optimism about the meeting's outcomes and plans to submit further responses to the FDA by the third quarter of 2024.

George Zorich, Chairman and CEO of Vyluma, conveyed satisfaction with the FDA meeting and highlighted the significance of Atropine Sulfate Ophthalmic Solution 0.01% for children diagnosed with myopia. According to Zorich, this treatment could play a crucial role in halting or lessening the progression of myopia in young patients.

The CHAMP study, a major multinational research project, was highlighted during the meeting. Conducted during the COVID period, it involved 576 children with myopia. The study demonstrated that Atropine Sulfate Ophthalmic Solution 0.01% is effective, producing results similar to those reported in existing literature. The study's principal investigator, Dr. Karla Zadnik from The Ohio State University, emphasized the importance of early myopia treatment to prevent severe long-term eye conditions. The CHAMP study showed consistent benefits in responder analysis, changes in spherical equivalent refraction (SER), axial length, and time to change in SER, with a statistical significance indicating that these benefits were not due to chance.

Myopia, commonly known as nearsightedness, is a prevalent refractive error that typically emerges in children between six and 14 years old. It progresses over several years before stabilizing in adulthood. Myopia causes the eye to elongate, leading to light focusing in front of the retina rather than directly on it, resulting in difficulty seeing distant objects clearly. This condition can increase the risk of serious eye complications and even blindness later in life. By 2050, it is estimated that approximately 5 billion people, or 50% of the global population, might suffer from myopia. Higher degrees of myopia significantly raise the likelihood of severe eye diseases such as myopic maculopathy, retinal detachment, and glaucoma.

Currently, interventions to slow myopia progression include spectacles and contact lenses. However, the safety of contact lenses is a concern due to risks like microbial keratitis and the potential for regression after discontinuation. Spectacles are an alternative for those who cannot or do not want to wear contact lenses. Given the potential long-term health impacts of myopia, new interventions are necessary to address the growing prevalence and severity of this condition.

Vyluma, Inc. is dedicated to the development of pharmaceutical treatments for refractive eye errors. Its leading therapy, NVK002, is an investigational atropine eye drop intended to slow myopia progression in children aged three and older. Vyluma is a subsidiary of Nevakar Inc., which focuses on innovative ophthalmic and injectable products to meet unmet medical needs. Nevakar, founded in 2015 and headquartered in Bridgewater, New Jersey, leverages the US 505(b)(2) regulatory pathway and excels in developing proprietary sterile pharmaceutical products.