Results from the ODAK FP7 project have helped leading international ophthalmic company SIFI, take AKANTIOR® closer to becoming the first approved orphan medicinal product for the rare infectious eye disease - Acanthamoeba keratitis.
In June SIFI announced the European Medicines Agency (EMA) has validated its Marketing Authorization Application for AKANTIOR® (polihexanide) for the treatment of acanthamoeba keratitis (AK). Professor John Dart, the pivotal Phase III clinical trial principal investigator and Honorary Clinical Professor at the Institute of Ophthalmology, University College London, stated, “AK is one of the most severe and painful eye infections and also one for which there is no licensed therapy. Most patients require months of treatment and 25% lose useful vision. Our 15 year drug development project culminated in October 2021 with the completion of the Phase III clinical trial which has demonstrated a high medical cure rate. Our findings show that AKANTIOR® will provide a majority of AK patients the prospect of recovering their vision and quality of life; I hope that this will soon become the standard of care for treatment of this disease.”
SIFI are aiming to commercially launch AKANTIOR® across Europe, by 2023, and is proactively launching a pan-European early access program to enable access for patients to AKANTIOR® without delay.
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