Periodic Reporting for period 1 - eyePoC (Clinical validation of a new diagnostic and monitoring PoC medical device based on quantification of biomarkers in tear fluids to improve the quality of eye health care)
Periodo di rendicontazione: 2014-10-01 al 2015-03-31
Dry eye disease is a particularly common and pervasive range of conditions. Demand for dry eye treatments is increasing worldwide and is spurred by a variety of factors. The eyePoC Project is proposed to clinically validate a novel PoC device, the so-called “TearMonitor”, based on direct detection and quantification of protein biomarkers in tears of patients affected of dry eye disease. The execution of this project will allow the involved partners, Horus-Pharma and Bioftalmik, to test the device in a coordinated multicentre study and to internationally launch the TearMonitor as a European initiative leaded by Pharmaceutical and Biotechnological SMEs. The support of this project by the European Commission will lead to a reduction of time to market, higher scope of centers, countries and final users to be reached, increased market impact on companies in the ophthalmology field worldwide and the possibility of address a bigger and more ambitious validation process.
At date, the technological results and achieves of the eyePoC project are such that the participants are able to approach the clinical validation of the IVD device. However, all along the implementation of antibodies to biomarkers recognition together with the requirements for analyzing very small volume of samples (such as tears), imposes the necessity of adapting or creating new solutions specifically for tear application. Due to eyePoC IVD is an “open platform”, it is possible to incorporate in the future novel biomarkers for others ocular diseases, generating a “Family of eyePoC products”.
Dry eye’s incidence rises with ageing, and longer life spans and aging populations throughout the world are key contributors to increased demand for treatment. Innovative and specific diagnostic tools are needed to help the clinicians in diagnosis and in treatment and surgical decision-making, due that day by day a greater variety of dry eye products and treatments with improved effectiveness are offering greater relief as they stimulate increased demand. A correct diagnosis will be traduced in a right and effective treatment.