Acanthamoeba keratitis: a rare disease (Orphan disease), living infectious organism, affecting the cornea that can develop into a severe form and be seriously debilitating.
The infection is caused by the protozoa Acanthamoeba, frequently in contact lens wearers due to poor hygiene and improper use, in other cases it can be caused by ocular trauma in a rural environment.
Pain, redness and eye irritation; blurred vision; hypersensitivity to light, and excessive tearing.
No drug licensed for the treatment of Acanthamoeba keratitis is currently available in any country. In recent years the administration of a combination (off label) of anti-amoebic agents such as biguanides and diamidin has greatly improved results.
Acanthamoeba keratitis is a rare(Orphan Disease) infectious living organism that affects the cornea and is caused by a protozoa of the Acanthamoeba family, present in soil, air and water.
The vast majority of cases (about 85%) appears in contact lens wearers, due to improper use of lenses, such as: inadequate cleaning and storage, night and prolonged usage, etc. However, infection can occur even after corneal trauma, especially in rural areas.
It is a form of keratitis with a fairly low prevalence (7 cases per 1,000,000 in Europe), but that can have devastating effects on patients, as it can cause intense pain and, if not effectively treated, can lead to major deterioration of vision (even blindness) and corneal perforation.
The most common symptoms are pain, redness, blurred vision, sensitivity to light and excessive tearing. These are manifestations similar to those of other eye infections and may persist for several weeks.
The natural history of the disease is related to the specific characteristics of Acanthamoeba, whose life consists of one active and one infectious stage of "dormant cysts", during which the organism manages to survive adverse environmental conditions.
Early diagnosis is extremely important and certainly improves the outcome of the infection.
To eradicate Acanthamoeba keratitis, therapy must rely on medications that can suppress the protozoa in both phases of its life cycle (one active and one cystic) in order to completely eradicate the pathogen agent.
No drug licensed for the treatment of Acanthamoeba keratitis is currently available in any country. In recent years the administration of a combination (off label) of anti-amoebic agents such as biguanides and diamidin has greatly improved results. The use of biguanides in particular has revolutionised the course of the disease, especially if treated in the early stages, because pain relief is fast. To get a complete clinical resolution, however, therapy is extended for several months; clinical resolution through medical treatment alone is obtained in the majority of patients (approximately 75%), and in many cases it is necessary to perform a corneal transplant during the course of the disease.
ODAK project and its partners
PHMB 0.02% solution
For the medical treatment of Acanthamoeba keratitis SIFI provides the Medical Doctors with 0.02 PHMB (Polihexanide) buffered physiological solution to be used as eye drops.
PHMB 0.02% solution can be provided by SIFI only within the Italian territory and in order to request it the Medical Doctors have to fill in a specific form and follow the recommended instructions
ODAK is a european FP7 project for the pharmaceutical development of an orphan drug for the rare ocular disease Acanthamoeba Keratitis.
Project Summary
Orphan Drug for Acanthamoeba Keratitis (ODAK)
ODAK is a research project to develop the Orphan Drug Polihexanide (PHMB) to provide a safe and effective drug for the treatment of Acanthamoeba keratitis. This is an infectious disease caused by a free living microorganism called Acanthamoeba, present in air, soil and water. The microorganism can infect eyes and is often linked to contact lens wearing, especially when poor eye-care is a factor.
Without treatment, this debilitating eye disease causes patients to suffer severe pain, vision loss and eye enucleation. Currently, there is no approved drug to treat this infectious rare disease. To improve this situation and provide an approved drug treatment, the ODAK project has been set-up. Led by SIFI SpA, an Italian company specialising in eye care products, the project is co-funded by the European Commission FP7 programme.
The ODAK project will undertake scientific research using laboratory experiments and clinical studies with patients, to provide scientific evidence to support the development of the first approved drug targeting Acanthamoeba keratitis. In addition the project will provide information and advice to doctors and healthcare providers on how to treat patients effectively.
Our research programme is expected to identify and test new PHMB formulations to find the most effective drug therapy for treating patients.
For a better knowledge of this serious disease and of its effects, patients suffering from Acanthamoeba Keratitis, their relatives, their friends and anybody providing care for them, can read the Patient information guide provided by Moorfields Eye Hospital.
