A two-day workshop for 200 experts in eye diseases from Europe, The United States, Australia, and Japan was assembled for the first time by the European Medicines Agency on 27 and 28 of October 2011. The experts reviewed scientific and regulatory challenges in developing medicines to treat individuals with eye disorders.

Novel treatments in ophthalmology (medicine designed to deal with the physiology, anatomy and diseases of the eye) are quickly progressing, with the recent development of innovative medicines for wet age-related macular degeneration. In addition, investigations are currently in process for new eye diseases where no treatment is yet available, such as dry age-related macular degeneration, pigmentosa and retinitis.

Participants, who included European regulators, doctors and patient representatives and the pharmaceutical industry, discussed:

  • Treatment for dry eyes
  • Techniques for measuring visual function in clinical trials
  • Developing stem cells and gene therapy for retinal diseases
  • Repairing the corneal surface with steam cells
  • and treatment for macular diseases and inflammation in the eye

In addition, they discussed the development of treatments for childhood eye disorders, such as glaucoma, eye inflammation, retinal diseases in premature babies, and pain relief following eye surgery. Specific challenges relate to the need for long-term safety data, measuring outcomes in children, as well as no high-quality information regarding current treatments used in areas such as eye inflammation.

Spiros Vamvakas, Head of Scientific Advice at the Agency, explained:

“The workshop was successful in developing interactions between European regulators, doctors and patient representatives and pharmaceutical industry in this area. We will now move forward with regulatory guidance in areas such as dry eyes and macular oedema – swelling in the back of the eye – which will require further stakeholder input.

Further discussion and research is needed before we can provide guidance in other areas such as trial designs and endpoints in inflammation of the eye, and advanced therapies in corneal and retinal disease.

The workshop identified the need for future submissions for endpoints and biomarker qualifications from companies, academia or consortia and we are looking forward to receiving these. We also encourage companies developing eye products to come and discuss their development plans with us at an early stage.”

The Agency will continue its public dialogue with academia, regulators, pharmaceutical industry, doctors and patients representatives on ophthalmology medicines.

Written by Grace Rattue