Sydnexis Receives Positive CHMP Opinion for SYD-101 in Pediatric Myopia
Sydnexis, Inc., a pre-commercial biopharmaceutical company, has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion for its proprietary low-dose atropine formulation, SYD-101, aimed at slowing the progression of pediatric myopia. This marks a significant milestone for the company, which is focused on developing treatments for eye diseases. The positive CHMP opinion also paves the way for the commercialization of SYD-101 in Europe, the Middle East, and Africa (EMEA), under the brand name Ryjunea®. The rights to market SYD-101 in these regions have been licensed to Santen SA, a Switzerland-based affiliate of Santen Pharmaceutical Co., Ltd., a leading Japanese company specializing in eye health.
“This is an incredible milestone for Sydnexis and comes on the heels of the FDA accepting our NDA for SYD-101 with a PDUFA date of October 23, 2025,” said Perry Sternberg, Chief Executive Officer of Sydnexis. “The CHMP’s positive opinion further validates the significant unmet need for effective treatment of pediatric myopia and underscores the critical importance of early intervention. It also confirms the potential benefit that SYD-101 can provide to millions of pediatric patients with progressive myopia.”
The CHMP’s positive opinion is largely based on data from Sydnexis’ pivotal Phase 3 clinical trial, known as the STAR study. This study evaluated the efficacy of SYD-101, a low-dose atropine formulation, in slowing the progression of pediatric myopia and reducing the risk of associated co-morbidities. The results of the trial showed that Ryjunea® met its primary endpoint, demonstrating its ability to slow the annual progression rate of myopia in pediatric patients aged 3 to 14 years over a 24-month period.
“Santen recognized early on that SYD-101’s novel, proprietary formulation was unique in its ability to deliver superior drug activity, maximum stability, and optimal comfort,” said Patrick Johnson, Ph.D., President of Sydnexis. “We are excited to partner with Santen, and we look forward to seeing SYD-101 reach the market across multiple continents, providing a much-needed solution for children suffering from myopia.”
Myopia, commonly known as nearsightedness, is the most prevalent eye disease among children and adolescents, affecting approximately one-third of this age group worldwide. By 2050, it is projected that more than 740 million children and adolescents will suffer from myopia, with the condition impacting over 5 billion people globally. Myopia, once considered a simple refractive error, is now recognized as a serious condition. Even low levels of myopia are associated with an increased risk of severe, irreversible eye diseases such as glaucoma, cataracts, and retinal detachment, which can lead to permanent vision loss later in life.
Professor Mark Bullimore, OD, Ph.D., expressed his enthusiasm about the potential impact of SYD-101, saying, “I am thrilled about the progress in bringing SYD-101 to market for the millions of pediatric patients affected by this growing epidemic. The news of CHMP’s positive opinion will be a game-changer in Europe, where low-dose atropine has been largely unavailable until now.”
Sydnexis, founded in 2014, is a privately held biopharmaceutical company based in San Diego, California. The company has recently completed the three-year primary endpoint of its pivotal Phase 3 clinical trial, which evaluated SYD-101 for slowing the progression of pediatric myopia. The trial is now in its fourth year, and the results from the third year will be announced after the completion of the fourth-year exploratory endpoints. Sydnexis is backed by four major venture investors: Visionary Ventures, RA Capital, Longitude Capital, and Bluestem Capital.
The success of SYD-101 is a crucial step forward in addressing the increasing global burden of pediatric myopia. As the incidence of myopia rises, particularly in urbanized regions, treatments that can slow its progression and reduce the risk of long-term complications are more essential than ever. SYD-101, with its novel formulation and proven efficacy, promises to be a key tool in managing this prevalent condition, improving patient outcomes, and potentially transforming the treatment landscape for pediatric myopia.
As Santen moves forward with its plans to introduce Ryjunea® in Europe, the Middle East, and Africa, the future of SYD-101 looks promising. The approval represents a significant advance in the effort to combat the growing myopia epidemic and underscores the potential of new treatments to improve the lives of millions of children worldwide. With the EMA’s endorsement and the upcoming FDA decision, SYD-101 is poised to become a leading therapy in the management of pediatric myopia.
