SEATTLE, April 11, 2019 /CNW/ -- LumiThera Inc., a commercial stage medical device company delivering photobiomodulation (PBM) treatment for ocular disorders and disease, today announced it has begun enrolling patients in a European Union multi-center clinical study in dry Age-Related Macular Degeneration (AMD) patients.
The randomized, multi-center, post-marketing study called LIGHTSITE II enrolled and treated the first patient at the James Paget University Hospital, UK. The multi-national European Union study is being conducted in eight leading retinal centers based in the UK, Germany, Spain, Italy and France. The study will enroll approximately 100 patients suffering from dry AMD and treat them over the course of about one year. In addition to demonstrating safety, key efficacy endpoints include visual acuity, contrast sensitivity and reduction of drusen deposits.
"I am delighted that we are able to offer some of our patients this very exciting new treatment," remarked Professor Ben Burton, Visiting Professor at the University of East Anglia, and Ophthalmologist, James Paget University Hospital. "To be the first center in the European Union multi-center trial up and running with this important study speaks volumes about the hard work and organization of my retinal trials team and the support of the hospitals management board for research."
In 2018, LumiThera obtained a CE mark to commercialize the Valeda™ Light Delivery System in European Union for the treatment of dry AMD. In February, the company announced that the National Institute of Health and division of the National Eye Institute was providing a $2.5M grant to support a multi-center clinical trial to lead to U.S. approval. The U.S. study will be an IDE study to support further approvals in the U.S. and elsewhere and is expected to be initiated later this year.
"We are starting two multi-center trials, one in European Union and one in the US," stated Clark Tedford, Ph.D., President and CEO. The European Union post-marketing study allows us to engage top retinal centers in key European countries and conduct a clinical trial that will expand our knowledge on PBM best practices for initial and follow-up treatment. The EU data will be used to further support our commercialization efforts and global regulatory submissions."
Visit the Company's website at www.lumithera.com.
About LumiThera Inc.
LumiThera is a commercial-stage medical device company focused on treating people affected by ocular disorders and diseases including dry age-related macular degeneration, a leading cause of blindness in adults over 65. The company is a leader in the use of PBM for treatment of acute and chronic ocular diseases and disorders. The company is developing the office-based Valeda Light Delivery System to be used by eye care specialists as medical treatments.
The Valeda Light Delivery System has been granted authorization to use the CE Mark by an EU Notified Body as required for commercial use in the European Union only. Valeda is not approved for use by the Food & Drug Administration (FDA) in the USA.
2019 LumiThera, Inc., All rights reserved.
SOURCE LumiThera Inc.
For further information: Clark Tedford, 1-360-536-5119, [email protected], http://www.lumithera.com