ODAK project: update

Pubblicato il

Thursday, 23 April 2015

Argomento

Eye infections

A short text prepared by CORDIS to present the project

Following the European Commission's approval of the Summary for the ODAK project (see interview with Dr Asero), the dissemination of project activities was initiated.
We offer the short summary (Results in Brief) prepared by the scientific editors of CORDIS, which carries out information and dissemination activities on behalf of the European Commission on EU-funded projects and their results.
The "Results in Brief" will be published in 6 languages; we offer the original English text together with the Italian version.

PHMB eye drops for treating Acanthamoeba ocular infections
A European study is testing a novel drug formulation for the treatment of a debilitating eye infection. It is also raising awareness about the risks of wearing contact lenses and the importance of prompt diagnosis of eye infections.
Acanthamoeba keratitis (AK) is a rare parasitic infectious disease of the eye affecting mainly individuals who wear disposable contact lenses. If not treated promptly, it can lead to visual impairment and even blindness. As a result, it is of primary importance to develop and establish efficacious treatment for AK.
With this in mind, the EU-funded 'Orphan drug for Acanthamoeba keratitis (http://www.odak-project.eu/ (ODAK)) project set out to test the efficacy of the drug Polihexanide (PHMB). PHMB has been designated as an orphan drug in the EU for the treatment of AK. During ODAK it will undergo non-clinical as well as Phase I/Phase III clinical evaluation. Apart from testing the quality, safety and efficacy of PHMB, ODAK partners will also provide recommendations for the clinical practice and management of AK.

Ph. 2: The protozoan Acanthamoeba spp. in the trophozoite stage

Retrospective evaluation of the clinical outcomes of AK patients treated with unlicensed drugs indicated that 96 % of patients were using contact lenses, and that PHMB was the most frequently used medication. The efficacy of PHMB established it as a promising candidate for obtaining an official AK treatment licence. ODAK partners therefore set out to optimise formulation of the PHMB active ingredient. Different formulations have so far been tested in terms of efficacy and ocular tolerance in pre-clinical models.
At the same time, the consortium is engaging in dissemination activities to raise awareness about the disease, its diagnosis and treatment, and preventative measures. The project has also been promoted on social media, providing information on its activities and progress.
By improving the current empirical treatment of AK with PHMB, ODAK hopes to increase drug bioavailability at the ocular surface and hence its therapeutic index. The envisioned eye drops formulation is expected to also minimise side-effects as well as the need for hospitalisation and surgery.

Key words: Eye infection, contact lenses, Acanthamoeba keratitis, Polyhexanide, PHMB, eye drops

A PHMB-based eye drops for the treatment of eye infections caused by Acanthamoeba
A European study is testing an innovative eye drops for the treatment of Acanthamoeba keratitis (AK), a debilitating eye infection. In parallel with their research activities, the partners in the European study called ODAK (Orphan Drug for Acanthamoeba Keratitis) are also carrying out actions to promote awareness of the risks associated with contact lens wear and the importance of early diagnosis of this rare eye infection.
Keratitis by Acanthamoeba is an eye disease, caused by a parasite, that mainly affects individuals who use disposable contact lenses. If not treated promptly, AK can lead to severe visual impairment and even blindness. Therefore, it is of paramount importance to develop and achieve an effective therapy against this rare but serious eye disease as soon as possible.
The project (http://www.odak-project.eu/), ODAK was initiated with European funding under the 7th Framework Programme with the aim of testing the efficacy of Poliexanide-based eye drops (PHMB). PHMB has been granted orphan drug designation by the European Commission for the treatment of AK. The ODAK project development programme includes the evaluation of PHMB eye drops in pre-clinical and Phase I/III clinical trials. In addition to evaluating the quality, safety and efficacy of PHMB, the ODAK partners will make recommendations for the practice and clinical management of AK.
Retrospective evaluation of clinical results on patients with AK treated with anti-amœbic preparations not yet granted Marketing Authorisation showed that 96% of the patients used contact lenses and that PHMB was the most frequently used drug preparation. This result makes PHMB a promising candidate in the treatment of AK.
The ODAK partners therefore set about developing PHMB eye drops. Several formulations have already been tested to define efficacy and ocular tolerability of PHMB in pre-clinical models.
In parallel, the ODAK consortium is engaged in dissemination activities to promote awareness of this disease in terms of diagnosis, drug treatment and prevention measures. The project was also promoted on social media, providing information on the activities carried out and the progress made.
By refining the currently used empirical treatment of AK with PHMB, the ODAK trial believes it will increase the bioavailability of the drug on the ocular surface and improve its therapeutic index. It is also expected that the investigational PHMB eye drops will not produce any significant side effects and will prevent the patient from hospitalisation and/or surgery at specialised centres.

Keywords: Eye infection, contact lenses, keratitis from Acanthamoeba, Poliexanide, PHMB, eye drops

Dr. Carmelo Chines
Direttore responsabile