Vyluma meets with FDA to discuss atropine sulfate ophthalmic solution 0.01% for the treatment of pediatric myopia


The Type A meeting addressed questions the FDA had about the late-stage product candidate

(Image Credit: AdobeStock/Panumas)

(Image Credit: AdobeStock/Panumas)

Vyluma Inc. announced it recently had a Type A meeting with representatives of the FDA’s Division of Ophthalmology to discuss the response to the FDA’s questions regarding its late-stage product candidate, atropine sulfate ophthalmic solution 0.01% under development to treat pediatric myopia.

According to the company, it is encouraged by the discussion with the FDA and will move forward with a submission to address the FDA’s questions in the third quarter of 2024.1

George Zorich, chairman and CEO of Vyluma, said in the news release he was pleased with the discussion that took place at the meeting with the FDA, and the company now has a pathway forward to respond to the FDA’s Complete Response Letter.

“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,” he said.

“We are very excited about the results of the CHAMP study,” Karla Zadnik, OD, PhD, Glenn A. Fry Professor in Optometry and Physiological Optics at The Ohio State University and the CHAMP study principal investigator,” said in the news release.

“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,” Zadnik added in the release. “Eye care practitioners’ efforts to treat myopia early on will be vital to decreasing the risk of long-term negative outcomes.”

The CHAMP study was a multinational study that enrolled 576 children with myopia. The study was conducted partly during the COVID-19 pandemic, and it demonstrated efficacy for atropine sulfate ophthalmic solution, 0.01% which proved to be consistent with the benefits reported in the published literature.1

Moreover, the company noted in the news release the study showed the efficacy 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.

Assessing the 3 key pre-specified endpoints (responder, mean change in SER, mean change in AL) together, investigators demonstrated that the observed favorable benefit in all 3 endpoints is unlikely due to chance (p=0.004).

Myopia is the leading cause of preventable blindness worldwide.2 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).3

Treatment options

According to a study, interventions to slow the progression of myopia include spectacles or contact lenses.4 While common treatment options for myopia include various contact lenses, safety remains a potential issue because the risk of sight-threatening microbial keratitis and the chance 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.

  1. Inc V. Vyluma Meets with FDA on Atropine Sulfate Ophthalmic Solution 0.01% Under Development to Treat Pediatric Myopia. GlobeNewswire News Room. Published June 18, 2024. Accessed June 18, 2024. https://www.globenewswire.com/news-release/2024/06/18/2900297/0/en/Vyluma-Meets-with-FDA-on-Atropine-Sulfate-Ophthalmic-Solution-0-01-Under-Development-to-Treat-Pediatric-Myopia.html
  2. 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
  3. 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
  4. Noel A. Brennan, Youssef M. Toubouti, Xu Cheng, Mark A. Bullimore. Efficacy in myopia control, Progress in Retinal and Eye Research. 2020;100923.
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