Enforcement Report - Week of February 1, 2023
CATANIA, Italy, Oct. 19, 2021 /PRNewswire/ -- SIFI, a leading international ophthalmic company, announced today that the pivotal Phase III study on polihexanide 0,08% monotherapy in adults and adolescents with Acanthamoeba keratitis (AK), met its primary endpoint of 'clinical resolution rate over a 12-month timeframe'. It also demonstrated an encouraging safety and tolerability profile. Based on these results, SIFI will request an accelerated assessment and plans to file a Marketing Authorisation Application (MAA) at the European Medicines Agency (EMA) for polihexanide 0,08% monotherapy under the Centralised Procedure for Orphan-Designated Medicinal Products in the first half of 2022.
Enforcement Report - Week of April 24, 2019