SEATTLE, June 8, 2022 /PRNewswire/ — Diopsys, Inc., a leader in modern visual electrophysiology medical devices today announced its move to expanded headquarters in Cedar Knolls, New Jersey. Diopsys became a wholly owned subsidiary of LumiThera, Inc. three months ago, and its relocation to a new 17,000 square foot facility will provide additional space for operations, research and development laboratories, warehouse and manufacturing capabilities.
LumiThera’s acquisition of Diopsys created a complementary diagnosis and monitoring platform for the Valeda® Light Delivery System, LumiThera’s leading treatment platform. Diopsys has an established commercial U.S. sales force that will combine with LumiThera’s EU sales team to serve a large, global footprint of eye care professionals.
“The new east coast operations center will aid the global expansion of the combined theranostic platforms,” indicated Matt Emmer, Vice President, Medical Affairs, Diopsys. “The theranostic company is focused on providing tools eye care professionals need to diagnose, treat, and monitor patients, to deliver a solution for multiple ocular diseases with limited treatment options.”
LumiThera’s recently announced the topline 13-month U.S. LIGHTSITE III trial data in intermediate dry Age-related Macular Degeneration (AMD) patients. The LIGHTSITE III trial enrolled 100 subjects, who received Valeda treatments every 4 months. A prespecified 13-month efficacy timepoint for all patients showed a sustained and statistically significant improvement in best corrected visual acuity as measured with the standard eyechart (p < 0.02). The topline results showed that over 55% of the intermediate dry AMD patients show >5 letters improvement with a mean of 9.7 letters; and over 26% of the patients showed >10 letter improvement with a mean of 12.8 letters. No safety issues were seen in the study results to date.
LIGHTSITE III is the ongoing U.S. pivotal study with the Valeda system, which showed a statistically significant improvement in vision in intermediate dry AMD subjects at 13 months and may provide a non-invasive treatment for patients that have limited treatment options and are progressing to geographic atrophy and irreversible vision loss. The US pivotal study results will be part of a PMA submission to FDA to seek approval for the treatment for US AMD patients. The Valeda device has already been approved in Europe and select countries in Latin America for the last 3 years.
“We are excited to expand operations in New Jersey as we rebrand the Diopsys diagnostic devices and work to bring Valeda therapy into the U.S. market,” stated Clark E. Tedford, Ph.D., President and CEO, LumiThera, Inc. “The new facilities provide us with the opportunity to broaden our research and development activities and create a pipeline of first-in-class products that can be used to address degenerative eye diseases early.”
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).
Diopsys, Inc. is a global leader in modern visual electrophysiology medical devices that help eye care professionals analyze the entire visual pathway for visual and neuro-visual disorders.
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 ValedaÒ 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 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.