(PRESS RELEASE) SEATTLE, WA — Diopsys, Inc., a leader in modern visual electrophysiology medical devices 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.