LumiThera today said it has completed its acquisition of Diopsys for an undisclosed amount.
The acquisition of the Pine Brook, N.J.-based electrophysiology medical device maker Diopsys was previously announced on Nov. 11, 2021. Through the deal, Diopsys stockholders will also receive stock in LumiThera, and Diopsys will become a wholly-owned subsidiary of the Seattle-based company.
LumiThera will add a complimentary diagnosis and monitoring platform, the Valeda light delivery system, to its ocular damage and disease treatment platform. LumiThera’s existing platform uses photobiomodulation for treating age-related macular degeneration. Diopsys’s established commercial sales in the U.S. will combine with LumiThera’s EU sales team to serve a larger global footprint of eye care professionals.
“We are excited for the new combined entity and the potential to prevent vision loss,” Diopsys president and CEO Joe Fontanetta said in a news release. “The theranostic company will provide the tools eye care professionals need to diagnose, treat, and monitor patients, providing a solution for multiple ocular diseases with limited treatment options.”
The deal precedes an anticipated release of LumiThera’s 13-month U.S. Lightsite III trial data in intermediate dry age-related macular degeneration (AMD) patients, according to the company. The trial enrolled 100 patients who are receiving Valeda treatments every four months. LumiThera said in a news release that 13-month efficacy time points for all patients are expected to provide a predesignated, early look at the primary vision endpoint. If the trial is successful, LumiThera will apply further efficacy analysis to support FDA approval.
LumiThera will continue to follow patients for 24 months for safety. The trial will remain masked and the primary endpoint will become the 21-month timepoint 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 endpoints and duration, in measuring the progression of vision loss in intermediate dry AMD patients, and how Valeda treatments can improve vision and impact disease progression,” LumiThera President and CEO Clark Tedford said in a news release. “We have seen positive clinical data in multiple clinical trials with Valeda in the last year. We have also seen increased adoption of Valeda’s non-invasive treatment for patients in approved European and South American countries over the last two years. We are excited to expand the approved use to the U.S. and other global populations.”