SEATTLE, July 26, 2022 /PRNewswire/ — LumiThera Inc., a commercial stage medical device company offering photobiomodulation (PBM) treatment for ocular damage and disease, today announced the purchase of MacuLogix assets by its wholly owned subsidiary. 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 eye care 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 US, 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,” 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.”
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 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. The pivotal U.S. study and previous clinical studies will support FDA submission for potential US 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.
“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.”
AMD is a leading cause of vision loss for people aged 65 and older. Losing central vision can make it harder to see faces, drive, or do close-up work like cooking or fixing things around the house. The overall prevalence of AMD is estimated to increase 7-fold with age, from 4.2% in those aged 45–49 years, to 27.2% in those aged 80–85 years. Globally, the prevalence is estimated to increase by 20% between 2020 (195.6 million) and 2030 (243.3 million).
MacuLogix, Inc. equips eye care professionals with the instrument, tools and education needed to effectively manage patients with age-related macular degeneration (AMD) by leveraging the science of dark adaptation through its AdaptDx® and AdaptDx Pro® guided by Theia™. Dark adaptation functional testing technology from MacuLogix enables eye care professionals to detect, monitor and treat AMD three years before it can be seen clinically. MacuLogix’s AMD Excellence Program® provides each customer with in-practice training and treatment best practices to support the implementation and optimization of dark adaptation testing. Visit www.maculogix.com for additional information.
Diopsys, Inc. is a leader in modern visual electrophysiology medical devices that help eye care professionals analyze the entire visual pathway for visual and neuro-visual disorders. The company provides Visual Evoked Potential (VEP) vision testing technology.
LumiThera is a commercial-stage medical device company focused on treating people affected by ocular damage and disease including dry age-related macular degeneration, a leading cause of blindness in adults over 65. The company is a leader in the use of PBM for treatment of visual disorders. The company is commercializing the office-based Valeda® Light Delivery System to be used by eyecare providers as medical treatments.
The Valeda Light Delivery System has been granted authorization to use the CE Mark by an EU Notified Body as required for commercial use in the European Union only. Valeda is available in select countries in Latin America. Valeda is not approved for use by the Food & Drug Administration (FDA) in the USA.
Visit the Company’s website at www.lumithera.com.
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SOURCE LumiThera Inc.