Lamellar Biomedical said today that the 1st patients were enrolled in its trial evaluating Lamelleye for the treatment of moderate to severe dry-eye disease.
Lamelleye uses the Scotland-based company’s Lamellasome technology to mimic the actions of serous lamellar bodies and regulate interfaces between tissues and external environments.
The trial is slated to compare Lamelleye to Optive Plus, a leading over-the-counter eye drop in patients with dry-eye disease.
The 30-patient study is expected to yield results in the 2nd half of this year. It is designed to evaluate the relative effectiveness of Lamelleye compared to Optive Plus based on outcomes such as invasive tear breakup time, symptom scores and rate of tear film evaporation.
“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 technology,” CEO Alec McLean said in prepared remarks. “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.”
The company’s Lamelleye won CE Mark clearance in the European Union in 2015.
