The European registration of a safe and effective drug for the treatment of Acanthamoeba keratitis is getting closer.
A.I.F.A. (Agenzia Italiana del Farmaco) has granted official authorisation to start the phase III clinical trial (ODAK 043/SI) in Italy of the study to evaluate the efficacy, safety and tolerability of a 0.08% ophthalmic solution of Polyhexamethylene Biguanide (PHMB) in patients suffering from Acanthamoeba keratitis, a serious eye infection that if not properly treated can irreversibly impair a patient's vision. The ophthalmic solution of PHMB 0.08% will be compared with the most commonly used off-label treatment, consisting of a combination of PHMB 0.02% and Propamidine 0.01%.
The Italian trial is part of a European multicentre clinical study entitled "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", in which two other countries (UK and Poland) are involved and which involves the treatment of a total of 130 patients suffering from Acanthamoeba keratitis.
"With the AIFA authorisation for the start of the trial, the clinical development of ODAK 043/SI opens to the recruitment of patients also in Italy," commented ODAK Project Director Dr. Antonino Asero with satisfaction, "The two centres where the phase III clinical trial will take place are the San Raffaele Hospital (Dr. Paolo Rama) and the Azienda Unità Locale Socio Sanitaria 3 Serenissima of Venice (Dr. Antonella Franch)."
The Acanthamoeba keratitis (CA) is a rare disease ('orphan disease'), affecting less than 0.1 in 10,000 EU citizens.
Acanthamoeba is a microbial protozoan with a life cycle consisting of two main phases: trophozoite and cyst. While the former is sensitive to the most common chemotherapeutic agents, the latter is an inactive form that can survive in extreme environmental conditions.
Patients with CA generally experience severe eye pain, photophobia, eye redness and irritation, blurred vision and excessive tearing.
Clinical signs include annular stromal infiltrates, epithelial defects and eyelid oedema.
Contact lens wearers are particularly at risk and account for up to 85 % of CA cases.
Patients often present with very severe forms of Acanthamoeba infection and about 25% of them have to resort to corneal transplantation.
ODAK (Orphan Drug for Acanthamoeba Keratitis) is a project funded under the "Seventh Framework Programme" by the European Commission and co-ordinated by SIFI. ODAK's objective is to develop PHMB 0.08% eye drops in the effective and safe treatment of Acanthamoeba keratitis.
The PHMB Due to its broad-spectrum antimicrobial activity, it has been generally used for about 60 years as a disinfectant in swimming pools, the cosmetics industry, surgical and non-surgical wound dressings and the food industry. PHMB works by binding to the amoeba's cell membrane, causing complex reactions to alter the integrity of its wall. This interaction with the cytoplasmic membrane results in the loss of cellular components and the inhibition of respiratory enzymes, which allows PHMB to enter, reducing the strength of the wall and thus the death of the microorganism.
For further information: http://www.odak-project.eu
Dr. Carmelo Chines
Direttore responsabile
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