News

After the health alert that suspended the marketing authorization of Perfluoron^® (product used in vitreo-retina surgery procedures), the new IOBA-CYTOTEST, patented methodology, developed in Valladolid, confirmed that the analyzed batches of this product were safe.

The European requirements (Directive 93/42/EEC Annex IX) recommended the International Organization for Standardization (ISO) 10993 and 16672 to assure safety of intraocular devices (Class IIb).  Unfortunately, IOBA research has proven that some of the existing tests that comply with such regulations are unable to detect toxicity.

The new direct methodology (IOBA-CYTOTEST) has been developed in order to support the safety of some intraocular medical devices, by IOBA (Eye Institute of the University of Valladolid), which has commissioned Vision R&D to perform it.

European Authorities and main suppliers of intraocular medical devices are now in contact with IOBA and Vision R&D to propose a modification of the current ISO norms.

On July 20, 2017, Dr. F. Jose Pinto-Fraga defended his Doctoral Thesis “New Tools in Dry Eye Disease Research: A More Efficient Clinical Trial Design Using Controlled Environment and Molecular Biomarkers, and a New Clinical Questionnaire”.

This thesis, received the designation of an International-awarded Doctorate Degree, was performed under the direction of Drs. M. Calonge, A. Enríquez de Salamanca and M.J. González-García. This is the latest work performed in the environment chamber (Vision R&D) in the CELab (Controlled Environment Laboratory) located at the IOBA building, University of Valladolid, Spain.

This research developed a novel two-step clinical trial design that, with only 20 patients in each arm, demonstrates how a therapy is not only effective against a patient’s Dry Eye Disease, but also protects their ocular surface against the worsening experienced through a 2-hr exposure to a controlled adverse environment. These adverse conditions are similar to those encountered in indoor offices, shopping centers, recreational facilities, cars, planes or even our own houses. This two-step design allows a potential therapy to also show a beneficial effect in normally encountered environmental situations.

Additionally, this kind of clinical trial allows examining patients thoroughly using the latest sophisticated tests so that the best primary clinical endpoints can be selected for future multicenter clinical trials.

Also important it is the fact that the collection of tears and cells from the ocular surface by minimally invasive means allows the detection of molecular biomarkers that help define the efficacy of the candidate drug.

In summary the two-step proof-of-concept or pilot clinical trial developed in CELab will provide the needed information for the go /no-go decision that pharmaceutical companies need in order to: 1) understand if their therapeutic candidate shows a therapeutic signal; 2) in which objectives that potential drug is showing a signal thus pointing at future primary/secondary endpoints; 3) to find out the best molecular signals that can define therapeutic efficacy for their drug.