SIFI Reports Positive Topline Results from Pivotal Phase 3 Study of Polihexanide for the Treatment of Acanthamoeba Keratitis

SIFI announced positive results from an active-controlled phase 3 study evaluating polihexanide (0.08%) monotherapy compared to a combination of polihexanide (0.02%) plus propamidine for the treatment of patients with Acanthamoeba Keratitis, a rare, sight-threatening parasitic eye infection. Propamidine is an antiseptic and disinfectant commonly used in the treatment of Acanthamoeba infection. Polihexanide monotherapy met the primary endpoint of clinical resolution rate over a 12-month timeframe. It also demonstrated an encouraging safety and tolerability profile. Based on these results, SIFI is requesting accelerated assessment from the European Medicines Agency (EMA) and intends to file a Marketing Authorization Application (MAA) in the first half of 2022. If approved, Polihexanide will become the first approved drug for the treatment of Acanthamoeba Keratitis. SIFI also intends to start on the regulatory pathway in the US, where the FDA has granted SIFI orphan drug designation.

The randomized, assessor-masked, active-controlled, multi-center trial was designed to evaluate the efficacy, safety, and tolerability of polihexanide 0.08% monotherapy compared to a combination of po...

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