LumiThera Inc. announced a new Category III CPT code to report “Photobiomodulation therapy of retina, single session” effective Jan. 1, 2025. According to LumiThera, support for this new Category III code came from many sources, including LumiThera’s clinical trial.

The purpose of the LIGHTSITE III clinical trial was to assess the safety and efficacy of photobiomodulation (PBM) treatment in patients with dry AMD, the company said. The primary efficacy endpoint, BCVA, was evaluated at 13 months and significantly improved (p <0.025). The 24-month data showed minimal safety risks and high patient compliance with more than 80% of the patients completing the six rounds of Valeda PBM treatment sessions.

The results demonstrated statistically significant improvement in the primary endpoint in BCVA at 13 months in the PBM treatment group over the sham-treatment group (p < 0.025). A mean increase in ETDRS letter score of >5.0 letters from baseline was seen at both the 13- and 21-month timepoints in the PBM-treated subjects’ BCVA (p < 0.0001). Fewer patients progressed to new geographic atrophy, a later stage scar that is seen with the permanent loss of retinal tissue.

“Establishing a unique CPT code for PBM use in retina is a positive step toward reimbursement,” stated Kevin J. Corcoran, Principal for Corcoran & Corcoran. “Not every application for a new CPT code is successful. Those that succeed, like this one, have support from the professional societies as well as evidence-based medicine published in the scientific literature.”