USFDA grants Orphan Drug Designation for Akantior

SIFI is currently evaluating various options for the commercialization of Akantior (polihexanide) globally, including potential out-license agreements outside its core markets

SIFI S.p.A, a leading international ophthalmic pharmaceutical company, announced that the U.S. Food and Drug Administration (USFDA), has approved the company's Orphan Drug Designation application for its investigational anti-infective polymer polihexanide for the treatment of fungal keratitis. This is a second orphan ophthalmic indication for the polihexanide Research & Development program.

Fungal keratitis is a severe corneal infection that often results in blindness and eye loss.  The disease is most prevalent in tropical and subtropical climates.  According to The Lancet, annual global incidence of fungal keratitis is estimated at 1,051,787 cases, with the highest rates in Asia and Latin America.  In the U.S., an estimated 15,660 patients annually ­– most of whom are contact lens wearers or agricultural workers – are diagnosed with fungal keratitis. Only one drug is currently approved for fungal keratitis in the U.S., and around one in three patients fail on the treatment. There are no approved treatments for fungal keratitis in Europe, Japan, Asia and almost anywhere else around the World. In addition to lack of approved medical alternatives, the company believes the incidence of fungal keratitis may be on the uptick due the global trend in general resistance to anti-fungal therapeutics.

"The opportunity of having a therapeutic option with new mode of action available to treat patients with fungal keratitis is a breakthrough," says Dr Edward Holland, Professor of Ophthalmology at the University of Cincinnati. "Currently, we have limited topical options and therefore resort to surgery too soon and often with the risk of poor outcomes as medical treatment proves unsuccessful especially for deeper infections."

"Over the last year, we have accomplished several pivotal milestones towards developing polihexanide first for acanthamoeba keratitis and now for fungal keratitis," explained Maria-Grazia Mazzone, Executive Director of Business & Portfolio Development at SIFI. "Both are catastrophic cornea infections with dire consequences and, sadly, areas of unmet medical need. For the sake of the patients we are encouraged by the recent decision of the FDA to grant ODD status to this program, which will enable the efficient development and ultimately approval of polihexanide for the treatment of fungal keratitis," concluded Mazzone.

SIFI is currently evaluating various options for the commercialization of Akantior (polihexanide) globally, including potential out-license agreements outside its core markets.