European Commission grants marketing authorization for acanthamoeba keratitis treatment
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The European Commission (EC) announced a marketing authorization approval for Avanzanite Bioscience’s Akantior (polyhexanide) for the treatment of acanthamoeba keratitis (AK). After 16 years of research and development, the monotherapy eye drop is now the first and only authorized medical product for the treatment of AK in the world, according to a news release.
The marketing authorization from the EC follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Product for Human Use and a recommendation by the EMA’s Committee for Orphan Medicinal Products. The solution will be targeted for both adult and pediatric patients 12 years and older who experience AK.
The positive opinion was based on findings from the pivotal Phase 3 Orphan Drug for Acanthamoeba Keratits (ODAK) trial, which included 135 patients. The trial found that almost 85% of patients treated with Akantior were cured, with almost 67% achieving full vision restoration. No patients involved in the study required an optical cornea transplant, and 7.5% required a therapeutic cornea transplant.
"Our studies have shown that with Akantior, when used as monotherapy following the treatment delivery protocol established during the trial, medical cure rates of over 85% can be achieved," said John Dart, MD, FRCS, FRCOphth, principal investigator of the ODAK trial and professor at the Moorfields Eye Hospital and the University College London Institute of Ophthalmology, in the release. "As the first authorized drug for AK, I expect this to become the standard of care for this severe disease."
Akantior is an anti-amoebic polymer formulated at a high 0.8 mh/ml (0.08%) dose strength and is administered in single-dose containers. According to Avanzanite, the eye drop has treated to more than 200 patients across 12 countries through a pre-authorization distribution program. Next steps for the company include collaborating with local health authorities in 26 European countries in order to obtain sustainable access agreements.
AK is a rare and severe parasitic corneal infection caused by Acanthamoeba, a free-living amoeba. The disease primarily affects contact lens wearers and can lead to blindness and, in extreme cases, the loss of the affected eye. Formerly, compounded or off-label therapies were the only treatment options for AK, which often required multiple cornea transplants with low graft survival rates, according to the release.
"No one fighting such a devastating rare disease should be left behind. This marketing authorization is the beginning of a new chapter for the treatment of AK and a monumental victory for AK patients in Europe," said Avanzanite Founder and CEO Adam Plich in the release.
Reference:
Avanzanite Bioscience Reports European Commission's Authorization of Orphan Medicinal Product AKANTIOR®. News release. Businesswire. August 27, 2024. Accessed August 30, 2024. https://www.businesswire.com/news/home/20240826744342/en/Avanzanite-Bioscience-Reports-European-Commissions-Authorisation-of-Orphan-Medicinal-Product-AKANTIOR%C2%AE
