LumiThera, developer of light-based treatments for eye diseases such as age-related macular degeneration (AMD), has acquired the maker of a diagnostic system it hopes will complement its efforts to monitor patients suffering from vision loss.
The company previously worked with its new wholly owned subsidiary, New Jersey-based Diopsys, to employ its electroretinography hardware in dry AMD clinical trials including a randomized, sham-controlled study that is expected to begin collecting efficacy data early this year after 13 months of treatment.
Diopsys’ equipment measures the electrical activity of the retina and how it responds to light. The company will supply its U.S. sales force as Washington-based LumiThera plans to take its photobiomodulation therapy to market.
LumiThera’s Valeda device, which received a CE mark approval in Europe, uses light-emitting diodes tuned to specific wavelengths designed to help stimulate cellular activity at the back of the eye and improve blood flow.
Combined together, LumiThera aims to offer a platform that allows ophthalmologists to diagnose a condition as well as quantitatively monitor patient responses to its therapy instead of relying on more subjective measures of visual acuity. The financial terms of the deal were not disclosed.
In 2021, Diopsys and LumiThera completed a pilot study in patients with intermediate dry AMD; 15 participants received Valeda treatments three times per week for three weeks, with retinal function evaluated with Diopsys’ Nova system.
According to the companies, measurements improved by 14.4% from baseline after the first month of therapy, with participants showing a 9% improvement after six months. LumiThera and Diopsys also noted a positive correlation between multi-luminance electroretinography readings and best corrected visual acuity scores.
The ongoing sham-controlled trial, which enrolled about 100 patients, mirrors FDA approval trials for drugs aimed at wet AMD in terms of clinical endpoints and duration, according to a statement from LumiThera President and CEO Clark Tedford. If the study proves successful, further efficacy analyses can be conducted to support FDA approval, the company said.
"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," Tedford said.