SIFI has announced the accomplishment of several targets concerning the regulatory procedure of polihexanide 0.8 mg/ml for the treatment of acanthamoeba keratitis.
- European Medicines Agency: Received AKANTIOR® Trade Name approval; Conducted favourable pre-Marketing Authorisation Applications meetings with designated Rapporteurs; Reiterated original guidance to submit MAA in Q2 2022.
- Food and Drug Administration: Requested Type B meeting, scheduled to take place in April 2022.
SIFI is evaluating different options for the commercialisation of AKANTIOR® globally, including potential out-licensing agreements for regions beyond its core markets.
Acanthamoeba Keratitis (AK) is a rare, acute, severe parasitic corneal infection caused by Acanthamoeba, a free-living amoeba. Acanthamoeba Keratitis is an ocular emergency and requires urgent treatment to save the eye. The incidence of Acanthamoeba Keratitis has been rapidly growing in recent years.
SIFI is a leading international ophthalmic company, headquartered in Italy, focusing on eye care since 1935. SIFI develops, manufactures, and markets innovative therapeutic solutions for patients with ophthalmic conditions.
Jelle Kleijn, Global Head of AKANTIOR®