Acanthamoeba keratitis monotherapy meets endpoint in phase 3 study
Based on positive topline results in a pivotal phase 3 study, SIFI will pursue an accelerated assessment for polyhexanide 0.08% monotherapy to treat Acanthamoeba keratitis, according to a company press release.
“Adequate treatment is a significant unmet clinical need for this severe parasitic corneal infection, as no treatment is currently licensed for AK in any country,” Fabrizio Chines, chairman and CEO of SIFI, said in the release. “The phase 3 data give us clarity that monotherapy with polihexanide 0.08% will effectively address this unmet medical need.”
The randomized, assessor-masked, active-controlled, multicenter trial investigated the safety, tolerability and efficacy of polyhexanide 0.08% monotherapy compared with a combination of polyhexanide 0.02% and propamidine 0.10%. The therapy met the primary endpoint of clinical resolution rate over 12 months.
SIFI intends to file a marketing authorization application with the European Medicines Agency for the therapy in the first half of 2022. Polyhexanide previously received FDA orphan drug designation, and the company plans to begin the regulatory process in the U.S.