FDA accepts new drug application for SYD-101 to treat pediatric myopia progression
Key takeaways:
- The new drug application is supported by 3-year data from the STAR study.
- If approved, SYD-101 would be the first pharmaceutical treatment to slow the progression of pediatric myopia in the U.S.
The FDA accepted a new drug application for SYD-101 to slow the progression of pediatric myopia and assigned a Prescription Drug User Fee Act date of Oct. 23, according to a press release from Sydnexis.
“There are no FDA-approved pharmaceutical products to treat myopia progression, which is rapidly increasing in incidence and associated with many ocular comorbidities,” Gregory Ostrow, MD, director of pediatric ophthalmology and adult strabismus at Scripps Clinic in San Diego, told Healio. “Ophthalmologists and optometrists are forced to use compounded products now to treat a disease that has become an epidemic in children. Because of the difficulty obtaining and risks associated with compounded drops, many eye care providers are not comfortable prescribing this effective treatment, and many children who could benefit from atropine do not get offered their best options.”
The STAR study is investigating SYD-101 (atropine sulfate ophthalmic solution 0.01% and 0.03%) to treat the progression of pediatric myopia and the risk for associated comorbidities, with 3-year primary and secondary endpoints supporting the application.
SYD-101 would be the first pharmaceutical option available in the U.S. to slow the progression of pediatric myopia, the release said.
“With approval, SYD-101 will fill the giant unmet need of these children and give eye care providers a safe and effective option to help slow this disease,” Ostrow told Healio.
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