CHMP backs first acanthamoeba keratitis treatment

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive recommendation for Akantior (polihexanide) as a treatment for acanthamoeba keratitis. This decision marks a significant step toward making Akantior the first approved medicine specifically for this condition.

Akantior, developed by the Italian ophthalmic healthcare company SIFI, was acquired by Netherlands-based Avanzanite in January this year. The licensing and supply agreement spans 26 countries within the European Economic Area and Switzerland. The CHMP’s backing comes as the committee prepares to send its recommendation for marketing authorisation to the European Commission, with a final decision anticipated in August 2024 for patients aged 12 and older.

Acanthamoeba keratitis is an eye infection caused by the Acanthamoeba amoeba, which infects the cornea and can lead to vision loss or blindness. The infection predominantly affects contact lens users and has been managed off-label with various antiseptic and antifungal agents, and in some instances, through corneal transplants.

Akantior functions as an anti-amoebic polymer that targets both the mobile trophozoites and the infective cysts of Acanthamoeba in the eye. Administered as monotherapy eye drops at a concentration of 0.8 mg/ml, the active substance in Akantior is polyhexanide.

The positive recommendation from the CHMP is based on comprehensive data spanning over 15 years, including a Phase III trial (NCT03274895) involving 135 patients with acanthamoeba keratitis. The trial results were promising, showing that 86.7% of the participants treated with Akantior were cured, with a median cure time of 4.1 months. Furthermore, only 7.5% of patients required a corneal transplant, and 66.7% regained full vision after treatment.

Adam Plich, CEO of Avanzanite, stated that the positive opinion from the CHMP brings the company closer to providing a much-needed treatment to patients suffering from this rare disease. Akantior has already been granted orphan drug status by both the EMA and the US Food and Drug Administration (FDA), which affords the company several pre-market advantages and could potentially grant market exclusivity upon approval.

This approval would not only represent a breakthrough in treating acanthamoeba keratitis but also highlight the importance of developing specialised treatments for rare conditions. Avanzanite's acquisition of the commercialisation rights to Akantior aligns with their broader strategy of addressing unmet medical needs in ophthalmology.

In addition to its work with Akantior, Avanzanite has also been active in other therapeutic areas. In February 2023, the company announced an exclusive distribution agreement with the French pharmaceutical company Advicenne for Sibnayal (potassium hydrogen carbonate/potassium citrate), a treatment for distal renal tubular acidosis (dRTA).

With the EMA’s favorable opinion and the potential forthcoming approval from the European Commission, Akantior could soon become a viable and much-needed treatment option for patients suffering from acanthamoeba keratitis, significantly improving outcomes and reducing the reliance on corneal transplants.