LumiThera Announces Purchase of MacuLogix Assets

LumiThera Announces Purchase of MacuLogix Assets

August 02, 2022

LumiThera Inc., a commercial stage medical device business that provides photobiomodulation (PBM) treatment for ocular disease and damage, announced that its wholly-owned subsidiary acquired the assets of MacuLogix.

MacuLogix, Inc., is the leader in early diagnosis of dry Age-related Macular Degeneration (AMD) patients and developer of the wearable AdaptDX Pro® dark adaptometer. With the use of the equipment, eye care specialists can measure dark adaptation, which is utilized to diagnose dry AMD in patients earlier than with any other technology. The AdaptDx Pro was introduced in 2020 and is offered for sale in the US, Canada, EU, and other nations.

"The core technology measures the inability to visually adapt to low levels of light, a key clinical marker seen in patients with early AMD. Dark adaptation technology has been validated in 42 peer-reviewed papers," stated Greg Jackson, Ph.D., former MacuLogix Chief Technology Officer and Co-Founder. "Over 1 million AdaptDX tests have been performed and about 200,000 patients have been newly diagnosed."

The purchase was made around four months after LumiThera revealed it had acquired the vision testing technology from Diopsys (visual evoked potential [VEP] and electroretinogram [ERG]). The Diopsys product line is a diagnostic and monitoring device that analyzes the electrical activity of the retina in response to a light stimulus, offering a quantitative vision measure to help with eye illness diagnosis and monitoring.

"AdaptDx Pro can identify dry AMD patients at the earliest timepoint, in advance of pathology, and before vision loss," stated Clark E. Tedford, Ph.D., President and CEO, LumiThera, Inc. "The AdaptDx wearable, light-based early diagnostic for dry AMD adds a complementary assessment of retinal health to the LumiThera product line, further expanding LumiThera's synergistic platform of products for eye care professionals. We are excited to combine diagnosis, treatment, and monitoring platforms to provide a complete solution for dry AMD patients."

The news from LumiThera comes after the company's 13-month positive U.S. LIGHTSITE III treatment data in patients with intermediate dry Age-related Macular Degeneration (AMD) treated with the Valeda® Light Delivery System were announced. 100 volunteers were enrolled in the LIGHTSITE III experiment, and they are receiving Valeda treatments every 4 months.

A 13-month efficacy timepoint for all patients met the predesignated primary best corrected visual acuity endpoint with a statistically significant improvement over the sham group (p = 0.02). The study showed improvements in best corrected visual acuity in intermediate dry AMD subjects with over 50% showing a line or better improvement on the eyechart with a mean of 9.7 letters gained for the responders.

Previous clinical trials as well as the crucial US research will support the FDA proposal for potential US clearance. Several nations in Latin America and Europe have currently approved the use of Valeda.