SIFI announced the European Commission has approved Akantior (polihexanide) for the treatment of acanthamoeba keratitis (AK) in adults and children from 12 years of age, confirming the orphan status of the product. Akantior is the first and only approved therapy for people suffering from AK in Europe, the company said in a press release.

AK is an ultra-rare, severe, progressive and sight threatening corneal infection characterized by intense pain and photophobia. AK is caused by a free-living amoeba, acanthamoeba, and primarily affects contact lens wearers.

According to Professor John Dart, of Moorfields Eye Hospital and the UCL Institute of Ophthalmology, who was Principal Investigator of the Phase 3 ODAK trial, “Akantior, when used as monotherapy with the trial's treatment protocol, achieves medical cure rates of over 86% and is set to become the standard of care for this severe and debilitating disease.” 

In Europe, SIFI plans to initiate its first commercial launch in Germany during the last quarter this year, followed by additional markets based on local regulatory, health-care technology assessment and reimbursement process timelines, including France, Italy, Romania, Spain, United Kingdom and Turkey addressing a total population of 430 million, and by Avanzanite, its commercial partner, in other European Countries addressing an additional population of 180 million, the company said.