A pivotal Phase III study on polihexanide 0.08% monotherapy in adults and adolescents with Acanthamoeba keratitis (AK), met its primary endpoint of a 'clinical resolution rate over a 12-month timeframe'.
It also demonstrated an encouraging safety and tolerability profile.
Based on these results, leading international ophthalmic company SIFI will request an accelerated assessment and plans to file a Marketing Authorisation Application at the European Medicines Agency (EMA) for polihexanide monotherapy under the Centralised Procedure for Orphan-Designated Medicinal Products in the first half of 2022.
The phase III readout is a milestone in addressing the huge unmet need to treat Acanthamoeba keratitis, a rare acute corneal parasitic infection that often leads to blindness and eye loss.
With these randomized, assessor-masked and active-controlled trial results, polihexanide could become the first approved drug for the treatment of this infection anywhere in the world. The development of polihexanide as a high-dose 0.08% monotherapy has taken 14 years to reach this point.
Professor John Dart, the trial's principal investigator and Honorary Clinical Professor at the Institute of Ophthalmology, University College London, stated: "This landmark trial of 135 patients represents a breakthrough in the management of AK. The trial showed that monotherapy with high-dose 0.08% polihexanide is likely to become the standard of care for patients devastated by AK." Professor Dart continued, "I'm particularly impressed by the very high clinical resolution rate which gives a high chance for the majority of patients to have their vision and their quality of life back. These results also give, for the first time, a well-defined protocol to the physicians' community, so that they are prepared for managing the increasing numbers of cases as well as the outbreaks that have occurred from time to time." "The results of this trial mark a fundamental milestone in our efforts to bring polihexanide to Acanthamoeba keratitis patients," stated Fabrizio Chines, Chairman and CEO of SIFI.
"Adequate treatment is a significant unmet clinical need for this severe parasitic corneal infection, as no treatment is currently licensed in any country. The Phase III data give us clarity that monotherapy with polihexanide 0.08% will effectively address this unmet medical need. We look forward to submitting the regulatory filing to the European Medicines Agency in 2022 and advancing this much needed medicine one step closer to patients. Finally, we extend our deepest gratitude to patients, caregivers, investigators, and study staff who participated in this phase III study and contributed to what we believe is an important medical advancement in the treatment of Acanthamoeba keratitis."
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