Lamellar Biomedical, a biotechnology company developing a range of patent-protected medical and pharmaceutical products, based on its LAMELLASOME™ technology, announced today the recruitment of the first patients in a clinical study assessing LAMELLEYE for the treatment of moderate to severe Dry Eye Disease (DED). Moderate to severe DED is a significant clinical problem for which there are no effective treatments that tackle the underlying cause.
LAMELLEYE (LAMELLEYE is a medical device, which received an EU CE mark in 2015) is designed to provide unique lubricating properties to patients with DED based on LAMELLASOME[TM] technology’s ability to mimic the actions of serous lamellar bodies. The new study will assess the clinical utility of LAMELLEYE and compare its performance with Optive Plus, a leading over-the-counter eye-drop for patients with DED.
The single-blind, randomised, cross-over study will recruit 30 patients and the results are expected to be reported in the second half of 2017. The study aims to collect clinical follow-up data on the use of LAMELLEYE and to assess the relative effectiveness of LAMELLEYE compared with the Optive Plus comparator eye drop. Outcomes include: non-invasive tear breakup time, symptom scores, rate of tear film evaporation (evaporimetry) and effect on the structure and quality of the tear film (interferometry).
Dr. Alec McLean, CEO of Lamellar Biomedical said, “We believe that LAMELLEYE has the potential to be an important advance in the treatment of DED given the unique lubricating properties of our LAMELLASOME[TM] technology. We anticipate that this new study will provide conclusive evidence of the clinical benefits that LAMELLEYE can deliver and demonstrate its superiority over an existing product for the relief of dry eye disease. We are looking forward to announcing the results of the study later this year, as they will be used to support the commercialization of this exciting new treatment in Europe in 2018, through a partner.”
Lamellar Biomedical has recently concluded a £5.75 million fundraising, which was led by Invesco and supported by the Scottish Investment Bank.