SIFI RECEIVES FAVORABLE FEEDBACK FROM THE US FDA ON AKANTIOR® FOR THE TREATMENT OF ACANTHAMOEBA KERATITIS

• Type B meeting feedback confirms SIFI's view that no additional data will be required for potential FDA approval of AKANTIOR^®
• AKANTIOR^® is poised to become the first FDA-approved medication for the treatment of acanthamoeba keratitis
• AKANTIOR^® is positioned for long term leadership in the U.S. with Orphan Drug Designation, NCE status, and formulation patent protection up to 2040

CATANIA, Italy, May 16, 2022 /PRNewswire/ -- SIFI S.p.A. ("SIFI" or the "Company"), a leading international ophthalmic company headquartered in Italy, announced today that it received favorable and supportive feedback from the United States Food and Drug Administration ("FDA") through a 'Type B' meeting held in early May regarding its potential regulatory application of AKANTIOR^® (polihexanide) for the treatment of acanthamoeba keratitis ("AK"). The outcome of the FDA meeting supports the Company's view that its existing data package, both clinical and non-clinical, will be sufficient for the submission of a New Drug Application ("NDA") and the FDA's potential approval of AKANTIOR^® in the U.S.  

Manuela Marrano, SIFI's Executive Director of Market Access and Regulatory Affairs, stated: "This is the culmination of more than 15 years of rare eye disease research conducted by SIFI, where polihexanide has consistently demonstrated highly safe and efficacious data in our clinical and non-clinical research, which we are grateful is now being recognized by the FDA."  Mrs. Marrano continued "We are currently working on the next step towards an ultimate FDA approval, which will be scheduling a pre-NDA meeting."

"I am highly encouraged by the feedback SIFI received from the FDA," stated Elmer Tu, MD, Professor of Clinical Ophthalmology and Director, Cornea Service, at the University of Illinois Eye and Ear Infirmary.  Dr. Tu continued, "Witnessing the unrelenting outbreak over the last 20 years and devastating impact of acanthamoeba keratitis on our individual patients coupled with the lack of an approved topical medication in the US, I enthusiastically welcome the prospect of having access to a highly safe and effective therapy for this destructive disease."

Fabrizio Chines, Chairman and CEO of SIFI, commented "Acanthamoeba keratitis is on the rise and there remains an unmet need to address this disease, as recently confirmed in the American Journal of Ophthalmology Case Reports [LINK], showing a 2.5 to 7-fold increase in incidence over a 15-year period at the University of Iowa Hospitals & Clinics." Mr. Chines concluded, "Through the granted Orphan Drug Designation, the upcoming New Chemical Entity status, and a patent on our proprietary formulation, AKANTIOR^® is securing long term exclusivity, up to 2040, in acanthamoeba keratitis. We look forward to bringing this innovation to the US market."

Today's announcement follows the Company's announcement in October 2021 that the pivotal Phase III trial of AKANTIOR^® in adults and adolescents with acanthamoeba keratitis met its primary endpoint (ClinicalTrials.gov Identifier: NCT03274895).  SIFI is evaluating commercialization strategies of AKANTIOR^® in the United States and other markets, including licensing agreements.

ABOUT AKANTIOR^®: AKANTIOR^® (polihexanide) stands to become the first approved drug for the treatment of acanthamoeba keratitis in the world. Polihexanide, a New Chemical Entity (NCE), 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 concentration which makes it possible to administer as monotherapy eye drops in preservative-free single-dose containers. In contrast, current treatment protocols include various non-standardized combination therapies involving unlicensed ? compounded or imported ? alternatives. Polihexanide is also being developed by SIFI for the treatment of fungal keratitis for which indication it also has FDA Orphan Drug Designation.

ABOUT Acanthamoeba Keratitis (AK): AK is a rare, acute, severe parasitic corneal infection caused by Acanthamoeba, a free-living amoeba. AK is an ocular emergency and requires urgent treatment to save the eye. It can lead to poor vision, potential blindness, or even eye loss and often requires single or multiple corneal transplants. It affects people of all ages, most of whom are young or middle-aged soft contact lens wearers. Patients report unbearable pain and extreme light sensitivity and can rarely work or lead normal lives until symptoms resolve. The incidence of AK has been rapidly growing in recent years.

ABOUT SIFI: 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. SIFI is fully committed through its R&D to improving the quality of life of patients, exporting treatments to more than 20 countries worldwide with a direct presence in Italy, Spain, France, Romania, Mexico, and Turkey.

Key Contact:

Jelle Kleijn
Global Head of AKANTIOR^®
+31 615643708
[email protected]

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