One step closer to the European registration of a safe and effective drug for the treatment of Acanthamoeba Keratitis.
SIFI is pleased to announce that AIFA (Italian Medicines Agency) has issued the official authorization to start Phase III clinical trial (ODAK 043 / SI) in Italy to assess efficacy, safety and tolerability of 0.08% Polyxamethylene Biguanide (PHMB) ophthalmic solution in patients with Acanthamoeba Keratitis, a severe eye infection that, if not adequately treated, can lead to serious vision impairment.
0.08% PHMB ophthalmic solution will be compared to the most widely used off label combination treatment, consisting of 0.02% PHMB and 0.01% Propamidine.
The Italian clinical trial is part of a multicenter European study "Randomized, Assessor-Masked, Active-Controlled, Phase 3 Study to Evaluate Efficacy, Safety and Tolerability of 0.08% Polyhexamethylene Biguanide (PHMB) Ophthalmic Solution in Comparison with 0.02% PHMB + 0.1% Propamidine Combination Therapy in Subjects Affected by Acanthamoeba Keratitis". The study will involve two other countries (UK and Poland)and will recruit a total of 130 patients suffering from Acanthamoeba Keratitis.
"AIFA authorization gives the opportunity to implement the patient recruitment of Phase III trial also in Italy", commented with satisfaction Antonino Asero, ODAK project director."The clinical study will take place at two centers: San Raffaele Hospital in Milan (Dr. Paolo Rama) and Azienda Unità Locale Socio Sanitaria 3 Serenissima in Venice (Dott.ssa Antonella Franch)."
Acanthamoeba Keratitis (AK) is a rare disease ("orphan disease") affecting less than 0.1 out of 10,000 EU citizens. Acanthamoeba is a microbial protozoan with a life cycle consisting of two main phases: trophozoitis and cysts. While the former is sensitive to the most common chemotherapeutic agents, the second is an inactive form that can survive in extreme environmental conditions.
Patients with AK usually experience severe eye pain, photophobia, eye redness and irritation, blurred vision, and excessive tearing. Clinical signs include a ring-like stromal infiltrates, epithelial defect, and lid edema.
Contact lens wearers are especially at risk and account for up to 85% of AKcases. Patients often have very serious forms of Acanthamoeba infection and about 25% of them require corneal transplant.
ODAK (OrphanDrug for Acanthamoeba Keratitis) is anEC funded FP7 (Seventh Framework Program) project led by SIFI. ODAK aims to developa 0.08% PHMB eye drops as an effective and safe treatment of AK.
Due to its antimicrobial broad-spectrum activity, PHMB has been widely used for around 60 years as a disinfectant in swimming pools, in the cosmetic industry, in surgical and non-surgical wound dressings and in the food industry. PHMB works by connecting to the cellular membrane of the amoeba, causing complex reactions to alter the integrity of its barriers. This interaction with the cytoplasmic membrane results in the loss of cellular components and the inhibition of respiratory enzymes allowing PHMB access, reducing barrier strength and hence inducing the death of the microorganism.
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