SIFI Announces Reimbursement Approval for AKANTIOR® in Spain

• AKANTIOR^® is anticipated to become available to Spanish patients on 1^st August
• Spain is the first Country in the world to approve the pricing and reimbursement of AKANTIOR^® for the treatment of Acanthamoeba Keratitis in adults and children from 12 years of age

CATANIA, Italy, July 14, 2025 /PRNewswire/ -- SIFI, a leading international ophthalmic company, today announced that the Spanish Interministerial Commission for Medicine Prices (CIPM) has issued a positive reimbursement opinion for AKANTIOR^® within Spain's national healthcare system.

SIFI expects the drug to be available under full reimbursement in Spain starting from 1^st August, following the customary resolutions by the General Directorate of Common Portfolio of Services of the National Health System and Pharmacy of the Ministry of Health.

"The reimbursement approval for AKANTIOR is a major step forward, bringing new hope for patients with AK in Spain and more confidence to ophthalmologists who care for them," said Dr. Ana Hervás Ontiveros, Ophthalmologist, Cornea and Refractive Surgery Specialist at La Fe Hospital, Valencia. "We have now in Spain the first approved, standardized, evidence-based treatment that dramatically improves patient outcomes and quality of life, preventing blindness in the worst cases."

AKANTIOR^® received European Commission approval as an orphan drug for the treatment of Acanthamoeba Keratitis (AK) in adults and children from 12 years of age in August 2024. The product is already available in Germany since October 2024.

AKANTIOR^® demonstrated unprecedented clinical results, achieving medical cure rates of 85% in a pivotal Phase III clinical trial, used as monotherapy according to the innovative treatment protocol.

Over 70 patients have been treated in Spain through early access programs ahead of the pricing and reimbursement approval. The current availability through the established processes at designated reference hospitals will remain in place until the commercial launch.

"The positive reimbursement opinion issued by the CIPM marks a strategic milestone in our European access strategy for AKANTIOR, whilst reimbursement procedures are still underway in France, Italy, the United Kingdom, and Germany." said Manuela Marrano, Executive Director, Market Access and Regulatory Affairs at SIFI. "Spanish authorities are the first in the world to recognize the value of this therapy for AK patients, making it widely and promptly available after diagnosis, a critical advantage to achieve superior clinical outcomes."

About Acanthamoeba Keratitis

Acanthamoeba Keratitis is an ultra-rare, severe, and progressive sight-threatening corneal infection characterized by intense pain and photophobia. The infection, caused by acanthamoeba, primarily affects contact lens wearers (generally young people) and can lead to permanent vision loss if left untreated or if not properly and promptly treated. With an estimated incidence of around 100 patients per year in Spain, AK has historically had no approved treatment options, leaving patients and healthcare providers with limited therapeutic empirical approaches.

About SIFI

SIFI is a leading international ophthalmic company headquartered in Italy, featuring an integrated business model spanning research and development to manufacturing and commercialization in both pharmaceutical and biomedical sectors. Since its foundation in 1935, SIFI's mission has been to improve people's lives through meaningful innovation in eye care. The company exports to more than 60 countries worldwide with direct presence in major European markets, Mexico, and through joint ventures in China and the United Arab Emirates.