Ryjunea Approved in EU for Pediatric Myopia

The European Commission (EC) has granted marketing authorization for Ryjunea (SYD-101), Sydnexis’ proprietary low-dose atropine formulation. This marks a historic milestone as Ryjunea becomes the first and only approved pharmaceutical treatment in the European Union for slowing the progression of pediatric myopia.

Indication and Product Details

Ryjunea is a 0.1 mg/ml ophthalmic solution intended for once-daily use. It is indicated for children aged 3 to 14 years at the initiation of treatment, who exhibit myopia progression of 0.5 diopters (D) or more per year, with a refractive error ranging from -0.5 D to -6.0 D.

Backed by Clinical Evidence from the STAR Study

The approval is based on data from the pivotal Phase 3 STAR study, which evaluated the efficacy and safety of SYD-101 in children with progressive myopia. The trial demonstrated that Ryjunea slowed the annual progression of myopia by 30% over two years compared to placebo. It also assessed the drug’s potential in reducing the risk of co-morbidities linked to high myopia.

Industry Perspectives

“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,” said Perry Sternberg, CEO of Sydnexis. “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.”

Commercialization Strategy and Global Outlook

The EC’s decision follows a recent positive opinion from the Committee for Medicinal Products for Human Use (CHMP). As part of a strategic partnership, Santen has licensed commercialization rights for SYD-101 in Europe, the Middle East, and Africa (EMEA) and will launch the product in these regions 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 FDA leading up to our October 23 PDUFA date.”