Vyluma Discusses Pediatric Myopia Treatment with FDA

Vyluma, Inc., a clinical-stage pharmaceutical company, recently held a Type A meeting with the U.S. Food and Drug Administration’s (FDA’s) Division of Ophthalmology to discuss questions regarding its advanced product candidate, Atropine Sulfate Ophthalmic Solution 0.01%. This eye drop is being developed to treat pediatric myopia, a condition characterized by nearsightedness in children.

The meeting, which took place on June 4, 2024, was described as productive by Vyluma’s Chairman and CEO, George Zorich. The discussions clarified the regulatory pathway for the company's 505(b)(2) New Drug Application (NDA). Vyluma plans to address the FDA’s questions formally in the third quarter of 2024. Zorich expressed optimism about the potential impact of Atropine Sulfate Ophthalmic Solution 0.01% on childhood myopia, emphasizing its potential to prevent or slow the progression of the condition.

Dr. Karla Zadnik, the principal investigator of the CHAMP study and a professor at The Ohio State University, shared excitement about the study’s findings. She highlighted the serious long-term risks associated with myopia, such as increased chances of developing severe eye diseases. Early intervention by eye care practitioners is essential to mitigate these risks.

The CHAMP study, a multinational research effort involving 576 children, demonstrated the efficacy of Atropine Sulfate Ophthalmic Solution 0.01%. Conducted partly during the COVID-19 pandemic, the study showed benefits consistent with existing literature. Key metrics like responder analysis, changes in spherical equivalent refraction (SER), axial length, and time to change in SER indicated significant positive outcomes. The combined assessment of these metrics showed that the benefits were statistically significant (p=0.004).

Pediatric myopia is a common refractive error that typically develops between ages six and 14, with progression continuing into adulthood. Myopia occurs when the eye’s axial length is longer than normal, causing light to focus in front of the retina, resulting in difficulty seeing distant objects clearly. By 2050, it is estimated that myopia could affect approximately 5 billion people globally, highlighting the urgency for effective treatments.

Current treatments for myopia include spectacles and contact lenses. Contact lenses, although effective, pose risks such as microbial keratitis (a serious corneal infection) and potential regression after discontinuation. Spectacles are an alternative for those unable or unwilling to use contact lenses. Given the significant implications of myopia on long-term eye health, additional interventions like Atropine Sulfate Ophthalmic Solution 0.01% are crucial.

Vyluma, a subsidiary of Nevakar Inc., specializes in developing pharmaceutical treatments for refractive errors of the eye. Their lead product, NVK002, is a preservative-free, low-dose atropine eye drop designed to slow myopia progression in children aged three and older. Vyluma’s development pipeline includes other products addressing unmet needs in treating eye conditions.

Nevakar Inc., the parent company of Vyluma, is a late-stage biopharmaceutical firm based in Bridgewater, New Jersey. Founded in 2015, Nevakar focuses on developing innovative ophthalmic and injectable products to meet critical medical needs and improve patient care. The company leverages the US 505(b)(2) regulatory pathway to develop and obtain approval for its pharmaceutical products.

The collaboration between Vyluma and the FDA marks a significant step forward in addressing pediatric myopia, a condition with serious long-term health implications. The promising results of the CHAMP study offer hope for effective management and treatment, ensuring better eye health outcomes for children worldwide.