LumiThera Obtains Approval by Health Canada to Start Age-related Macular Degeneration Clinical Study

SEATTLE, March 24, 2016 /PRNewswire/ — LumiThera Inc., a developmental stage medical device company creating a non-invasive photobiomodulation (PBM) treatment for ocular disorders and disease, today announced it has obtained Health Canada approval of their LIGHTSITE clinical study to treat dry Age-related Macular Degeneration (AMD) subjects. The pilot clinical trial is in part sponsored by a grant with the National Institute of Health (NIH) and the division of the National Eye Institute (NEI).

Age-related macular degeneration accounts for 8.7% of all blindness worldwide and is the most common cause of blindness in developed countries, particularly in people older than 60 years. Its prevalence is likely to increase as a consequence of exponential population aging. Approximately, 85-90% of the AMD patients have the “dry” form of the disease. The emotional and socioeconomic impact of AMD is large because of the reading and driving vision impairment caused by the disease, which primarily affects central (straight-on) rather than peripheral (side) vision.

“The LIGHTSITE clinical study is being conducted with Principal Investigators, Drs. Robert Devenyi and Samuel Markowitz,” stated Clark Tedford, Ph.D., President and CEO. “The clinical site is currently screening patients, and enrolling subjects in the LIGHTSITE trial is another step closer to commercialization for a non-invasive treatment for dry AMD patients.”

“The design of the study is to extend the previous clinical benefits in a double-masked, randomized, sham-controlled, parallel group study to assess the safety and efficacy of PBM in subjects with dry AMD”, said Sam Markowitz, M.D. and co-Investigator. “We believe this study will lay a solid foundation for the LumiThera device as a novel therapeutic approach to treating a very debilitating, degenerative ocular disease.”

The NIH/NEI grant partially supports the pilot human clinical trial in subjects with dry AMD with LumiThera, Inc. The dry AMD study will evaluate clinical and anatomical outcomes in the eye following a 3-week course of treatments with PBM. The treatment will be repeated at the 6-month time period and subjects will be followed for 12 months.

“LumiThera has demonstrated promising data with their PBM approach already,” says co-Investigator, Dr. Robert Devenyi, Ophthalmologist-in-Chief and Director of Retinal Services, University of Toronto. “The current study will now utilize the LumiThera instrument and test the subject’s vision as well as examine disease pathology in the eye following the repeat treatments in these subjects over the course of one year.”

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About LumiThera Inc.
LumiThera is a developmental-stage medical device company focused on treating people affected by dry age-related macular degeneration. The Company was founded by a team of physicians, scientists, and engineers, with backgrounds in the use of photobiomodulation (“PBM”), using non-invasive light emitting diodes (“LED”) and laser treatments for acute and chronic ocular diseases and disorders. The Company is developing an ophthalmologist LED office-based instrument to be used in multiple ocular conditions or disorders as non-invasive medical treatments.

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SOURCE LumiThera Inc.