The European Medicines Agency (EMEA) has been formally notified by
Bausch & Lomb Ireland of its decision to withdraw the application for a
centralised marketing authorisation for the medicinal product Retisert
(fluocinolone acetonide) 590 microgram Intravitreal Implant.
Retisert was expected to be used for the treatment of chronic
non-infectious uveitis affecting the posterior segment of the eye.
Retisert was designated as an orphan medicinal product on 7 March 2005.
The application for marketing authorisation for Retisert was submitted
to the EMEA on 8 September 2006. At the time of the withdrawal, it was
under review by the Agency’s Committee for Medicinal Products for Human
Use (CHMP).
In its official letter, the company stated that the withdrawal of
Retisert was based on the CHMP’s request for additional information, to
which the company was unable to respond within the permitted timeframe.
More information about Retisert and the state of the scientific
assessment at the time of withdrawal will be made available in a
question-and-answer document. This document, together with the
withdrawal letter from the company, will be published on the EMEA
website in due course.
1. Withdrawal of an application does not prejudice the possibility
of a company making a new application at a later stage.
2. This press release, together with other information on the work
of the EMEA, can be found on the EMEA website: emea.europa.eu