SIFI Reports the CHMP’s Positive Opinion of Akantior (Polihexanide) to Treat Acanthamoeba Keratitis
Shots:
- The CHMP grants a positive opinion to Akantior for treating acanthamoeba keratitis based on the P-I & P-III studies. The final decision is anticipated in Aug 2024, to be valid across the EU incl. Iceland, Liechtenstein & Norway
- The P-I trial determined the effect of different polihexanide concentrations vs PBO among healthy individuals (n=90) and verified that polihexanide (0.8mg/ml) had no significant differences in AEs vs PBO
- The P-III (Study 043/SI) trial of polihexanide (0.8mg/ml or 0.08%) in acanthamoeba keratitis adults & adolescents (n=135) showed 86.7% of clinical resolution rate with 4mos. median time to cure plus improved vision & QoL
Ref: PR Newswire | Image: SIFI
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