Dry eye diagnostic nears US approval

November 10, 2008

The TearLab Osmolarity System and Osmolarity Test Card have been submitted to the FDA for premarket authorization in the US, according to an announcement from the manufacturer of TearLab, Occulogix.

The TearLab Osmolarity System and Osmolarity Test Card have been submitted to the FDA for premarket authorization in the US, according to an announcement made by TearLab's manufacturer, Occulogix.

To support the application, OcuSense, a subsidiary of Occulogix, has conducted a multicentre safety and efficacy study of the System, which requires <50 nanolitres of tears to measure osmolarity. OcuSense will announce its results at this year's meeting of the American Academy of Ophthalmology.

The TearLab System, which is CE marked, is currently available in selected European countries.