European Commission Approves AKANTIOR® by SIFI

30 August 2024
SIFI, a prominent international ophthalmic company, has announced that the European Commission has granted approval for AKANTIOR® (polihexanide) for the treatment of acanthamoeba keratitis (AK) in both adults and children aged 12 and above. This approval confirms the orphan status of the product, making AKANTIOR the first and only authorized treatment for AK in Europe.

Acanthamoeba keratitis is a rare, severe, and progressive corneal infection that poses a significant threat to vision. It is characterized by intense pain and sensitivity to light. The condition is caused by a free-living amoeba called acanthamoeba, which predominantly affects individuals who wear contact lenses.

Fabrizio Chines, Chairman and CEO of SIFI, highlighted the significance of this approval, stating that it represents a vital step toward establishing a new global standard of care for AK patients. He emphasized that for the first time in Europe, AK patients now have an approved therapy, marking a new era in the treatment of this potentially blinding disease. Chines also mentioned that SIFI is committed to further developing polihexanide for other corneal infections, such as fungal keratitis, where they have already received orphan drug designation from both the EMA and the FDA.

Professor John Dart from Moorfields Eye Hospital and the UCL Institute of Ophthalmology, who served as the Principal Investigator of the Phase III ODAK trial, stated that AKANTIOR, when used as a monotherapy following the trial's treatment protocol, achieves medical cure rates exceeding 86%. He noted that the approval from the European Medicines Agency and European Commission came after 15 years of extensive research and the pivotal Phase III clinical trial. This breakthrough treatment offers a significant improvement over current options and has the potential to prevent blindness. AKANTIOR has been recommended for use with the detailed treatment protocol used in the Phase III trial, providing a standardized and effective approach that can be followed by any clinician. This method has proven effective not only in the trial but also in the current compassionate use program.

Juliette Vila Sinclair Spence, a rare disease patient advocate and Chairwoman and Founder of the AK Eye Foundation, expressed her optimism, stating that the approval of AKANTIOR brings AK patients, referred to as AK Warriors, closer to accessing the best possible treatment in the EU. She emphasized that this milestone is a significant step towards providing equitable healthcare to AK Warriors, offering them hope for a brighter future.

SIFI plans to launch AKANTIOR commercially in Germany by the last quarter of this year, followed by other markets including France, Italy, Romania, Spain, the United Kingdom, and Turkey. In collaboration with its commercial partner Avanzanite, the company aims to address a total population of 430 million in these countries, with an additional 180 million individuals in other European countries. According to scientific publications, the incidence of acanthamoeba keratitis is estimated to be 1 to 4 patients per million inhabitants.

AKANTIOR (polihexanide 0.08%) is an anti-amoebic polymer that targets both the active and cyst forms of the protozoan acanthamoeba. It is formulated at a concentration of 0.08%, facilitating its use as monotherapy eye drops in single-dose containers. The European Commission has confirmed the orphan status of the product, and the FDA has granted SIFI Orphan Drug Designation for the treatment of acanthamoeba keratitis.

Acanthamoeba keratitis is a severe parasitic corneal infection caused by acanthamoeba, a free-living amoeba. The condition has been increasingly prevalent in recent years and requires urgent treatment to prevent vision loss or eye damage. It primarily affects young to middle-aged soft contact lens wearers, causing unbearable pain and extreme light sensitivity, significantly impairing their ability to work or lead normal lives until symptoms are resolved.

SIFI, headquartered in Italy, has a long-standing history in the ophthalmic sector, dating back to its foundation in 1935. The company focuses on improving eye care through innovation and exports its products to over 40 countries, with a direct presence in major European markets, Mexico, China, and the United Arab Emirates.

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