ODAK is an industry led FP7 project which aims to develop a safe and effective treatment for a rare eye disease Acanthamoeba keratitis (AK), a devastating and severely debilitating condition which can lead to blindness and in over 85% of cases associated with contact lens wearing.
AK is caused by a common protozoan (Acanthamoeba spp.) infecting the cornea which is extremely difficult to treat because of the pathogens resistance to antimicrobial therapy. It affects 1 in 100,000 people in the EU.
The drug PHMB has been given the orphan drug designation for the treatment of AK by the European Medicines Agency following an application made by SIFI, the leading partner in the ODAK project.
"The use of the PHMB has greatly improved treatment outcomes for AK especially when used in the early stages of the disease".
Preclinical trials are in progress with clinical trials due to start in 2015.
This five year project is being delivered by a consortium of five European companies and one university and is co-funded by the EU Seventh Frameworks Programme.
Prof John Dart leading Ophthalmologist at Moorfields Eye Hospital London said "Acanthamoeba keratitis is an uncommon disease but life changing for most individuals affected. There is currently no approved, licensed treatment for this condition. The EU is to be commended for making this important investment into the development of a safe and effective medical therapy for the condition".
The ODAK research project has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement number 305661.
Acanthamoeba keratitis was extremely rare before the widespread use of contact lenses. The number of cases started to increase since the mid 1980's, when the association between AK and the use of contact lenses was established. Symptoms can include severe eye pain, eye redness, blurred vision, light sensitivity, eye irritation and excessive tearing. Clinical signs range from epithelial micro erosion and patchy anterior stromal infiltrates, and in later phases of the disease corneal ulcers, and melting and dense corneal abscesses.
Diagnosis of AK is problematic as symptoms are often mistaken for bacterial or herpes virus infections resulting in delayed treatment. Early diagnosis and treatment is a major factor in achieving good treatment outcomes for AK. Typically diagnosis includes clinical examination, culture and histology of infected corneal epithelium and stroma, while confocal microscopy is used in some centres.About PHMB Currently there are no agents approved for the treatment of AK. In recent years combinations of anti-amoebic agents such as biguanides and diamidines have greatly improved the treatment outcome of AK. They have shown some efficacy but the treatment regimens and the concentrations of active agents are based on empirical safety and efficacy data. Some authors have identified PHMB as the most common "ideal choice" for monotherapy in treating AK. The ODAK project will develop stable, safe and effective formulations for non-clinical studies including pharmacokinetics, toxicology, and pharmacodynamics to support the choice of formulations to be used in clinical trials.
Recruitment into the Phase I and Phase III clinical trials will begin in 2015. Trial sites are to be confirmed.