Sydnexis Announces European Commission Approval of Ryjunea, the First Treatment for Slowing the Progression of Pediatric Myopia
The European Commission (EC) has granted marketing authorization for Sydnexis' SYD-101 (branded as Ryjunea), the company’s proprietary low-dose atropine formulation, for slowing the progression of pediatric myopia.
Ryjunea becomes the the first and only approved pharmaceutical treatment option to treat myopia progression in EU countries.
Ryjunea, which is available as a 0.1 mg/ml ophthalmic solution for once-daily administration, is indicated in children aged 3 to 14 years at treatment initiation and with myopia progression of 0.5 D or more per year and a severity of -0.5 D to -6.0 D. The approval is backed by data from the STAR study, Sydnexis’ pivotal phase 3 clinical trial that showed Ryjunea slowed annual myopia progression by 30% over 2 years compared with placebo in children 3 to 14 years old at treatment initiation.
The approval is backed by data from the STAR study, Sydnexis’ pivotal phase 3 clinical trial evaluating its proprietary low-dose atropine formulation to slow the progression of pediatric myopia and the risk of associated co-morbidities in children 3 to 14 years old at treatment initiation.
“This marks a significant milestone for Sydnexis and, most importantly, for pediatric patients with progressive myopia, their families, and physicians as the first and only approved pharmaceutical treatment option in Europe,” Perry Sternberg, Chief Executive Officer of Sydnexis, said in a company news release. “This approval is an endorsement of the potential benefit SYD-101 can provide to millions of patients globally and reinforces the critical importance of early intervention.”
The marketing approval from the EC follows the recent positive opinion from the Committee for Medicinal Products for Human Use (CHMP). Santen licensed the rights from Sydnexis to commercialize SYD-101 in the regions of Europe, Middle East, and Africa (EMEA) and will launch SYD-101 under the brand name Ryjunea.
“The EU approval of SYD-101 is a recognition of the compelling safety and efficacy data generated from our landmark STAR study,” said Patrick Johnson, PhD, President of Sydnexis. “This validates the potential benefit that SYD-101 can provide to pediatric myopes in Europe and we are excited about our continued interactions with the Food and Drug Administration (FDA) leading up to our October 23 PDUFA date.”