SEATTLE—LumiThera Inc., a commercial stage medical device company offering photobiomodulation (PBM) treatment for ocular damage and disease, announced the purchase of MacuLogix assets by its wholly owned subsidiary, according to an announcement. 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. The device allows eyecare professionals to measure dark adaptation, which is used to diagnose dry AMD in patients earlier than any other technology.

The AdaptDx Pro, launched in 2020, is available for sale in the U.S., Canada, EU and other countries.
"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," said Greg Jackson, Ph.D., former MacuLogix chief technology officer and co-founder. "Over one million AdaptDX tests have been performed and about 200,000 patients have been newly diagnosed."
"AdaptDx Pro can identify dry AMD patients at the earliest timepoint, in advance of pathology, and before vision loss," saidClark 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 eyecare professionals. We are excited to combine diagnosis, treatment, and monitoring platforms to provide a complete solution for dry AMD patients."
LumiThera's announcement follows the release of its positive 13-month U.S. LIGHTSITE III treatment data in intermediate dry Age-related Macular Degeneration (AMD) patients with the Valeda Light Delivery System. The LIGHTSITE III trial enrolled 100 subjects, who are receiving Valeda treatments every four 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 percent showing a line or better improvement on the eye chart with a mean of 9.7 letters gained for the responders. The pivotal U.S. study and previous clinical studies will support FDA submission for potential U.S. approval. Valeda is currently approved in Europe and several countries in Latin America.
In March, LumiThera announced the acquisition of the Diopsys Visual Evoked Potential (VEP) and Electroretinogram (ERG) vision testing technology. The Diopsys product line, is an established diagnostic and monitoring system that measures the electrical activity of the retina of the eye in response to a light stimulus, providing a quantitative vision measure to assist in diagnosis and monitoring of eye disease.