Dry eye diagnostic nears US approval

Article

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.

Newsletter

Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.

Recent Videos
Jay Chhablani, MD, shares late-breaking data from the ArMaDa trial, investigating gene therapy for Geographic Atrophy and dry age-related macular degeneration, at EURETINA
Editorial advisory board member Alexandra Miere, MD, PhD, speaks about the ACTOR and HERMES studies at the 2025 European Society of Retina Specialists (EURETINA) Congress
María Berrocal, MD, speaks about the Vit-Buckle Society symposium hosted at the 2025 European Society of Retina Specialists (EURETINA) annual meeting
© 2025 MJH Life Sciences

All rights reserved.