LumiThera Inc., a commercial-stage medical device company focused on developing photobiomodulation (PBM) therapies for ocular disorders and disease, announced a distribution agreement with Optos Plc, a division of Nikon, Inc., Japan to exclusively distribute the Valeda™ Light Delivery System for the treatment of dry age-related macular degeneration (AMD) in 12 European countries. Optos is recognized as the leading provider of ultra-widefield retinal imaging devices to eyecare professionals for improved patient eye care. The announcement follows the recent CE Mark Certification for the European Union (EU) for the treatment of dry AMD utilizing LumiThera’s Valeda™ Light Delivery System.
“The Distribution agreement with Optos allows LumiThera to begin commercialization throughout Europe and establishes a collaboration with a partner in the retinal imaging area,” stated Clark Tedford, Ph.D., LumiThera President and CEO. “Optos is a global leader in ultra-widefield retinal imaging technologies and we are honored to be working with them to open up a new age in the treatment of AMD.”
“Optos is pleased to add the Valeda™ Light Delivery System to our product range and to further support eye care professionals to diagnose and manage retinal diseases. This arrangement allows our customers to visualize AMD in the far periphery with color and autofluorescence ultra-widefield retinal imaging and provide a PBM treatment for dry AMD. This is very important for the patients who have this complicated, degenerative disease,” stated Robert Kennedy, Chief Executive Officer, Optos.
LumiThera recently sponsored a symposium on PBM in ocular disease and presented final data from the LIGHTSITE I study at the Euretina conference in September 2018 and has a multi-center trial in Europe planned to begin in the near term to further support clinical, anatomical, and patient benefits with the Valeda™ Light Delivery System. The therapy consists of a series of light-based treatments to the retinal cells, resulting in improved energy production and addressing inflammation, ischemia and metabolic dysfunction that contribute to the disease.
About LumiThera Inc.
LumiThera is a commercial-stage medical device company focused on treating people affected by ocular disorders and diseases including dry AMD, a leading cause of blindness in adults over 65. The Company is a leader in the use of photobiomodulation for the 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 device has been granted authorization to use the CE Mark by a 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.
Optos is the leading retinal imaging company, acquired by Nikon in 2015. It’s core technology, ultra-widefield (UWF™) high resolution digital images (optomap®) capture approximately 82% and 200º of the retina, something no other device is capable of doing in a single image. In 2018, the company announced a new product offering that combines ultra-widefield retinal imaging and optical coherence tomography (OCT) scans. For more information about Optos, please visit www.optos.com.