The European Medicines Agency hosted the first workshop on 27 and 28 October 2011 which assembled European and international experts to discuss the way forward in developing ophthalmology medicines. The participants also tackled the development of treatment in childhood eye disorders and they agreed that further discussion and research is needed before they can provide guidance in other areas such as trial designs and endpoints in inflammation of the eye.
 

The workshop on medicines for eye disorders hosted by the European Medicines Agency assembled for the first time some 200 experts in eye diseases from Europe, Australia, Japan and the United States of America. The attendees reviewed regulatory and scientific challenges in developing medicines for eye disorders. Among the attendees there were representatives from the European regulators, the pharmaceutical industry, doctors and patients.

In particular the participants discussed methods for measuring visual function in clinical trials, developing stem cells and gene therapy for retinal diseases, treatment for macular diseases and inflammation in the eye, repairing the corneal surface with stem cells and treatment for dry eyes. In addition, they also tackled the development of treatment in childhood eye disorders such as retinal diseases in premature babies, childhood glaucoma, eye inflammation and relief of pain after eye surgery. Particular challenges relate to measuring outcomes in children, the absence of good-quality information on existing treatments used in areas such as eye inflammation, and the need for long-term safety data.

According to Spiros Vamvakas, Head of Scientific Advice at the Agency, the workshop identified the need for future submissions for endpoints and biomarker qualifications from companies, academia or consortia. Mr Vamvakas also encouraged companies developing eye products to discuss their development plans with the Agency at an early stage. The Agency will continue its public dialogue with academia, regulators, pharmaceutical industry, doctors and patients’ representatives on ophthalmology medicines. Recently the European Medicines Agency introduced a simplified process for SMEs register for better communicate with them.