EMA Eyes Ophthalmic Medicines - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

EMA Eyes Ophthalmic Medicines


ePT--the Electronic Newsletter of Pharmaceutical Technology

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.”

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
38%
Breakthrough designations
13%
Protecting the supply chain
38%
Expedited reviews of drug submissions
13%
More stakeholder involvement
0%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
USP Faces New Challenges
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here