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.”
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