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.
FURTHER INFORMATION:
Jelle Kleijn, Global Head of AKANTIOR®
E: jelle.kleijn@sifigroup.com
