Vyluma Meets with FDA on Atropine Sulfate Ophthalmic Solution 0.01% Under Development to Treat Pediatric Myopia

2024-06-18

临床结果

Vyluma Discusses Response to FDA’s Questions and Clarifies Regulatory Pathway for its 505(b)(2) NDA

BRIDGEWATER, N.J., June 18, 2024 (GLOBE NEWSWIRE) -- Vyluma, Inc. (“Vyluma”), a clinical stage pharmaceutical company is focused on the development of ophthalmic treatments for disease states with limited treatment options. On June 4, 2024, the Company had a Type A meeting with representatives of the U.S. Food and Drug Administration’s (FDA’s) Division of Ophthalmology to discuss the response to FDA’s questions regarding its late-stage product candidate, Atropine Sulfate Ophthalmic Solution 0.01% under development to treat pediatric myopia. Vyluma is very encouraged by the discussion with FDA and will move forward with a submission to address FDA’s questions in the third quarter of 2024.

“I am very pleased with the discussion that took place at the meeting with FDA, and we have a pathway forward to respond to FDA’s Complete Response Letter,” stated George Zorich, Chairman and CEO of Vyluma. “We believe that Atropine Sulfate Ophthalmic Solution 0.01% will make a profound difference for children who are diagnosed with myopia to prevent or reduce further progression.”

“We are very excited about the results of the CHAMP study,” said Karla Zadnik, OD, PhD, Glenn A. Fry Professor in Optometry and Physiological Optics at The Ohio State University and the CHAMP study principal investigator. Dr. Zadnik stated that, “Myopia leads to a higher risk for serious eye conditions to develop eventually, and the higher the level of myopia, the higher the risk for serious eye diseases. Eye care practitioners’ efforts to treat myopia early on will be vital to decreasing the risk of long-term negative outcomes.”

The CHAMP Study

The CHAMP study was a multinational study that enrolled 576 children with myopia, was conducted partly during COVID, and demonstrated efficacy for Atropine Sulfate Ophthalmic Solution, 0.01% that is consistent with the benefits reported in the published literature. The CHAMP study demonstrated a consistent benefit of Atropine Sulfate Ophthalmic Solution, 0.01% in a responder analysis, change in spherical equivalent refraction (SER), change in axial length, and time to change in SER. When the 3 main pre-specified endpoints (responder, mean change in SER, mean change in AL) were assessed together, it was shown that the observed favorable benefit in all three endpoints is unlikely due to chance (p=0.004).

What Is Pediatric Myopia?

Myopia, or nearsightedness, is a common refractive anomaly that often begins between the ages of six and 14 years and progresses over several years before stabilizing and lasting through adulthood. With myopia, the eye’s axial length is longer than normal (from front to back), which causes light to focus in front of the retina instead of directly on it.1,2 Those with myopia have difficulty seeing distant objects, but near objects are clear. Myopia is a condition that may lead to higher risk of blindness and serious eye complications later in life.

Myopia is the leading cause of preventable blindness worldwide.3 If current trends continue, it is estimated that by 2050 there will be approximately 5 billion people with myopia (50% of the world’s population).4 Higher levels of myopia significantly increase a child’s risk for serious blinding eye disease in their lifetime, such as myopic maculopathy, posterior staphyloma, retinal detachment, cataract, and glaucoma.5

Current Treatment Options

Interventions to slow the progression of myopia include spectacles or contact lenses.5 Common treatments for myopia include various contact lens options, but safety remains a concern because the risk of sight-threatening microbial keratitis (bacterial infection of the cornea) and the possibility of regression after discontinuation of lens wear.4 Spectacles are another treatment option for children who are unable or prefer not to wear contact lenses.

Given the impact myopia may have on an individual’s long-term health and that it is a widespread condition, additional interventions are needed to help mitigate the prevalence and severity of this condition.

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.

References

American Optometric Association. Myopia (Nearsightedness). Accessed 6/4/2021.

American Academy of Ophthalmology. Myopia Control in Children. Accessed 6/4/2021.

Wu W, Xie Y, Liu X, et al. Analysis of Scientific Collaboration Networks among Authors, Institutions, and Countries Studying Adolescent Myopia Prevention and Control: A Review Article.Iran J Public Health. 2019;48(4):621-631.

Lawrenson JG, Dhakal R, Verkicharla PK, Shah R, Huntjens B, Downie LE, Kernohan A, Li T, Virgili G, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta‐ Cochrane Database of Systematic Reviews 2021, Issue 4. Art. No.: CD014758. DOI: 10.1002/14651858.CD014758.

Noel A. Brennan, Youssef M. Toubouti, Xu Cheng, Mark A. Bullimore. Efficacy in myopia control, Progress in Retinal and Eye Research. 2020;100923.

Media Contact:

Houman Hemmati, MD, PhD

Chief Medical Affairs Officer

hhemmati@vyluma.com