Lamellar Biomedical Recruits First Patients Into Clinical Study Assessing LAMELLEYE for Treatment of Dry Eye Disease
|Posted by australiandryeye on June 9, 2017 at 4:00 AM|
Lamellar Biomedical, a biotechnology company developing a range of patent-protected medical and pharmaceutical products, based on its LAMELLASOME™ technology, announces 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 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).
LAMELLEYE is a medical device, which received an EU CE mark in 2015.
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.
About Dry Eye Disease (DED)
The major cause of Dry Eye Disease (DED) is when the outer lipid layer is deficient, allowing the eye to dry due to increased evaporation.
The consequences of DED are multiple, including symptoms of discomfort, burning and of grit in the eye. Visual disturbance is common with potential for damage to the cornea including long-term scarring and subsequent loss of vision. In severe cases Filamentary Keratitis can develop. This is a painful lesion where mucus filaments stick to the corneal surface and with each blink, the eyelids tug at the filaments, stimulating pain-sensitive corneal nerves.
The market for dry eye products is large and growing encompassing prescription and OTC products which in aggregate generate sales in excess of US$2 billion per annum and which are anticipated to grow significantly.
About Lamellar Biomedical
Lamellar Biomedical is the only company globally focused on LAMELLASOME[TM] technology (micron-scale lipid vesicles), which has multiple medical applications.
Lamellar Biomedical's development pipeline includes a number of patent-protected medical devices and pharmaceuticals targeting Dry Eye Disease, Dry Mouth in Head and Neck cancer, Cystic Fibrosis and Infection. These are all conditions that are poorly served by current medications and therefore represent areas of high value unmet medical need.
LAMELLASOME[TM] technology produces mimetics of human serous lamellar bodies. These regulate the internal interfaces between human tissues as well as the interfaces between tissues and the external environment as in the mouth and lungs. They act biophysically, are muco-restorative and have the potential to resolve a broad range of disease states that are associated with dry or sticky mucosal surfaces and topical infection.
Lamellar Biomedical is based near Glasgow, Scotland. It has been financed by a range of investors including Invesco, Scottish Enterprise, Barwell and TRI Capital. In March, the Company raised £5.75 million in a Series C fund raising.
For more information please visit: http://www.lamellar.com
For further information, please contact:
Dr. Alec McLean
Citigate Dewe Rogerson
David Dible / Shabnam Bashir
SOURCE Lamellar Biomedical