Europe Hails Visionary Breakthrough: First-Ever Drug to Combat Childhood Myopia Approved!

Olivia PatelJun 5, 2025
A stylized image of a child's bright, clear eye, with a subtle, protective light gently emanating from the pupil, symbolizing the new treatment shielding their vision from the progression of myopia.
  • Landmark EU approval has been granted for SYD-101, to be commercialized as Ryjunea, the first and only pharmaceutical treatment to slow the relentless progression of pediatric myopia3, 4.
  • This groundbreaking therapy, born from the innovative labs of Sydnexis, offers a powerful new weapon against a rapidly escalating global epidemic threatening millions of children's eyesight6.
  • Backed by the compelling efficacy and safety data from the pivotal STAR study, SYD-101 promises to protect the vision of future generations and marks a new era in pediatric eye care3, 4, 8.

A shadow has loomed over the futures of millions of children: pediatric myopia, an insidious creep stealing clear sight and threatening devastating, irreversible conditions like retinal detachment and glaucoma later in life8. But today, a beacon of hope pierces through the growing gloom! The European Commission has granted a historic marketing authorization for SYD-101, a revolutionary low-dose atropine formulation from Sydnexis, marking an unprecedented victory in the battle for children's vision3, 4.

For years, families and physicians have grappled with this escalating global epidemic, projected to affect a staggering 740 million children and adolescents by 20506. Now, under the brand name Ryjunea, this pioneering treatment – the first and only of its kind approved in EU countries – offers a scientifically validated shield. The landmark STAR study provided compelling proof, demonstrating SYD-101's power to reduce the annual progression of myopia by 30% over two years compared to a placebo, alongside a favorable safety and tolerability profile3, 4, 8.

"This marks a significant milestone... for pediatric patients with progressive myopia, their families, and physicians," stated Perry Sternberg, CEO of Sydnexis, heralding the dawn of proactive intervention. With exclusive licensing partner Santen set to commercialize Ryjunea across Europe, the Middle East, and Africa, the tide is finally turning against this widespread threat3, 4, 5. Millions of children now have a tangible new defense to protect their precious sight, ushering in a transformative era in pediatric eye care.


References

  1. www.ema.europa.eu
  2. reviewofmm.com
  3. www.businesswire.com
  4. pharmatimes.com
  5. eyewire.news
  6. www.sydnexis.com
  7. www.ophthalmologytimes.com
  8. touchophthalmology.com

Stay Updated!

Get the latest biotech and pharma news delivered to your inbox.