EMA Eyes Ophthalmic Medicines - - BioPharm International


EMA Eyes Ophthalmic Medicines

BioPharm Bulletin

Seeking to review the regulatory and scientific challenges in developing ophthalmic medicines, EMA for the first time brought together eye-disease experts from Europe, Asia, and the US for a two-day workshop. According to a press statement, the workshop was designed to enable EMA and attendees to review regulatory and scientific challenges in developing medicines for eye disorders.

Attendees, which included European regulators, the pharmaceutical industry, doctors, and patient representatives, identified the fact that new developments and treatments are advancing the field of opthalmology rapidly. For example, the industry has recently witnessed breakthroughs in new medicines for wet age-related macular degeneration, as well as ongoing research in disease such as retinitis pigmentosa and dry age-related macular degeneration, which currently have no treatments.

Also discussed at the workshop were 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. Childhood eye disorders and their associated treatments were also discussed, with workshop participants identifying challenges relating 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.

“The workshop was successful in developing interactions between European regulators, doctors, and patient representatives and pharmaceutical industry,” Spiros Vamvakas, head of scientific advice at EMA, said in the statement. “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.”

However, Vamvakes also added that further research and discussion will be required before guidance in other areas, such as trial designs and endpoints in eye inflammation, and advanced therapies in corneal and retinal disease, can be provided.

“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,” said Vamvakes. “We also encourage companies developing eye products to come and discuss their development plans with us at an early stage.”

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