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 associated with 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 individuals earlier than any other technology. The AdaptDx Professional, launched in 2020, is available for sale in the US, Canada , EU and other countries.
“The core technologies measures the inability to visually adapt in order to low levels of light, a key clinical marker seen in sufferers 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 possess been newly diagnosed. ”
LumiThera’s announcement follows the release of the positive 13-month U. S. LIGHTSITE III treatment data in intermediate dry Age-related Macular Deterioration (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 greatest corrected visible acuity in intermediate dry AMD subjects with more than 50% showing a line or better improvement on the eyechart with a mean associated with 9. 7 letters gained for the particular responders. The particular 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) plus Electroretinogram (ERG) vision testing technology. The Diopsys product line, is an established diagnostic and monitoring system that measures the particular electrical activity of the retina from the eye in response to a light stimulus, providing a quantitative vision measure to assist in diagnosis and supervising of eye disease.
“AdaptDx Pro can identify dry AMD individuals at the earliest timepoint, within advance of pathology, and before vision loss, ” stated Clark E. Tedford , Ph level. D., President and CEO, LumiThera, Incorporation. “The AdaptDx wearable, light-based early analysis for dry out AMD adds a complementary assessment associated with retinal health to the LumiThera product line, further expanding LumiThera’s synergistic platform of products for vision care professionals. We are excited to combine diagnosis, therapy, and monitoring platforms to provide a complete solution for dry AMD sufferers. ”
About ADVANCED MICRO DEVICES
AMD is the leading cause of eyesight loss for people aged 65 plus older. Losing central vision can make it harder to see faces, drive, or do close-up work like cooking or even fixing things around the particular house. The overall prevalence of AMD is estimated to increase 7-fold with age, from four. 2% in those aged 45–49 years, to 27. 2% within those older 80–85 many years. Globally, the prevalence will be estimated to increase by 20% between 2020 (195. 6 million) and 2030 (243. 3 million).
MacuLogix, Inc. equips eye treatment professionals using the instrument, tools and education needed in order to effectively manage patients with age-related macular degeneration (AMD) by leveraging the science of black 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 may be seen clinically. MacuLogix’s AMD Excellence Program ® provides each customer with in-practice training plus 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 inside modern visual electrophysiology healthcare devices that will help attention care experts analyze the particular entire visible pathway with regard to visual and neuro-visual disorders. The organization provides Visible Evoked Possible (VEP) vision testing technologies.
LumiThera is usually a commercial-stage medical device company focused on treating people affected by ocular damage and disease including dry out age-related macular degeneration, the 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 simply by eyecare providers as medical treatments.
The Valeda Light Delivery Program has been granted authorization to use the CE Mark by an EU Notified Body as required for commercial use in the particular European Union only. Valeda is available in select countries in Latin America . Valeda is not authorized for use by the Food & Drug Administration (FDA) in the USA .
Visit the Company’s website at www.lumithera.com .
2022 LumiThera, Inc., All rights reserved.
SOURCE LumiThera Inc.