LumiThera said today it won Health Canada approval for its Lightsite clinical trial examining the effect of its non-invasive photobiomodulation treatment in patients with age-related macular degeneration.
The Seattle-based company’s study is being sponsored by a grant from the National Institute of Health and the division of the National Eye Institute.
“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. 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,” co-investigator Dr. Sam Markowitz said in prepared remarks.
The grants from the NIH/NEI will partially support the pilot human clinical trial in patients with dry AMD, which has already begun to screen and enroll subjects, the company said.
“The Lightsite clinical study is being conducted with principal investigators, Drs. Robert Devenyi and Samuel Markowitz. 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,” CEO Clark Tedford said in a prepared statement.
The study will evaluate the clinical and anatomical outcomes in the eye after a 3-week course of treatments with the company’s PBM system, LumiThera said. Treatment will be repeated at 6 months with sujects followed for up to 12.
“LumiThera has demonstrated promising data with their PBM approach already. 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 1 year,” co-investigator Dr. Robert Devenyi of the University of Toronto said in a press release.