SIFI announced the European Commission approved Akantior (polyhexanide 0.08%) for the treatment of acanthamoebakeratitis (AK) in adults and children from age 12 and older, confirming the orphan drug status of the product.

Akantior is an anti-amoebic polymer that acts on both the trophozoites and cysts of the protozoan acanthamoeba. It is formulated at a 0.8mg/ml (0.08%) concentration, which makes it possible to administer as monotherapy eye drops in single-dose containers. The European Commission confirmed the orphan drug status of the product. The U.S. Food and Drug Administration granted SIFI orphan drug designation for the treatment of acanthamoeba keratitis.