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
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here