Retina International Press Release – Dublin, 12 May 2025:
Retina International Welcomes Positive CHMP Opinion on First Targeted Therapy for Rare Eye Diseases – Thyroid Eye Disease (TED).
Retina International welcomes the recommendation by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to approve Tepezza (teprotumumab), developed by Amgen, as the first targeted therapy for adults living with moderate to severe Thyroid Eye Disease (TED) in the European Union.
TED, also known as Graves’ eye disease, is a rare and debilitating condition that causes inflammation and swelling around the eyes, often leading to eye bulging, double vision, eye pain, and in the most severe cases, permanent vision loss and disfigurement. For decades, treatment has relied on general anti-inflammatory drugs and surgical intervention, offering only limited relief.
Tepezza represents a breakthrough: it is the first treatment specifically developed to interrupt the disease process itself. Clinical trials have shown that the therapy significantly reduces the bulging of the eyes (proptosis) and improves other painful and disruptive symptoms after just 24 weeks of treatment.
“This is a pivotal moment for the TED community,” said Avril Daly, CEO of Retina International. “We commend the CHMP for recognising the high unmet need for an effective treatment option targeting this community, and we applaud Amgen for bringing forward this innovation that offers real hope to patients living with a rare eye disease. Tepezza represents not just a therapeutic advance, but a path to preserved vision and improved quality of life. When patients living with forms of rare eye diseased are asked what would be meaningful to them, they highlight the preservation and stability of their vision and slower degeneration as a priority.”
While common side effects include fatigue, nausea, and muscle spasms, more serious risks such as hearing impairment and effects during pregnancy will be closely monitored through safety measures that accompany the approval process.
The CHMP’s opinion will now be forwarded to the European Commission, which is responsible for granting EU-wide marketing authorisation. Once approved, decisions regarding pricing and reimbursement will take place at the national level in each EU Member State.
Retina International remains a strong advocate for accelerating patient access to innovative treatments that improve life for those living with rare and complex eye diseases.
About Retina International
Retina International is a global patient-led organisation dedicated to promoting research, education, and advocacy for people living with rare and inherited retinal diseases.
About Amgen
Amgen is a leading biotechnology company committed to unlocking the potential of biology for patients by discovering, developing, and delivering innovative human therapeutics.
About the EMA CHMP
The Committee for Medicinal Products for Human Use (CHMP) is the European Medicines Agency’s committee responsible for evaluating medicines intended for use in the European Union.
Further quotes/interview available:
Avril Daly, CEO, Retina International
Email: Avril.Daly@retina-international.org
Media enquiries
Claire Duggan, Communications Manager, Retina International
E-mail: Claire.Duggan@retina-international.org or communications@retina-international.org
