LumiThera announced today that it has completed the acquisition of Diopsys for an undisclosed amount.
The acquisition of Diopsys, a manufacturer of electrophysiology medical devices based in Pine Brook, New Jersey, was previously announced on November 11, 2021. Through this agreement, Diopsys shareholders will also receive shares of LumiThera and Diopsys will become a wholly owned subsidiary of Seattle-based company.
LumiThera will add a complementary diagnostic and monitoring platform, the Valeda Light Delivery System, to its ocular injury and disease treatment platform. LumiThera’s existing platform uses photobiomodulation to treat age-related macular degeneration. Diopsys’ established commercial sales in the United States will be combined with LumiThera’s European sales team to serve a larger global footprint of eye care professionals.
“We are excited about the new combined entity and the potential for vision loss prevention,” Diopsys President and CEO Joe Fontanetta said in a press release. “Theranostics Company will provide the tools eye care professionals need to diagnose, treat and monitor patients, providing a solution for multiple eye diseases with limited treatment options.”
The agreement comes ahead of the early release of data from LumiThera’s 13-month U.S. Lightsite III trial in patients with intermediate dry age-related macular degeneration (AMD), according to the company. The trial recruited 100 patients who receive Valeda treatments every four months. LumiThera said in a press release that 13-month efficacy timelines for all patients should provide an early, predefined insight into the primary endpoint of vision. If the trial is successful, LumiThera will apply additional efficacy analysis to support FDA approval.
LumiThera will continue to follow patients for 24 months for safety reasons. The trial will remain hidden and the primary endpoint will become the 21-month time frame if the groups have not separated at 13 months, according to the company.
“The Lightsite III trial mirrors FDA approval trials for wet AMD drugs in terms of parameters and duration, measuring the progression of vision loss in patients with intermediate dry AMD, and how Valeda treatments can improve vision and impact disease progression,” said Clark Tedford, President and CEO of LumiThera. said in a press release. “We have seen positive clinical data in multiple clinical trials with Valeda over the past year. We have also seen an increase in the uptake of Valeda’s non-invasive treatment for patients in European and South American countries approved for over the past two years. We are excited to expand approved use in the United States and other global populations.