LumiThera Announces First CPT Code to Report Photobiomodulation Therapy in Retinal Disease

LumiThera announced a new Category III CPT code, effective January 1, 2025. The code, "Photobiomodulation therapy of retina, single session,” was approved by the AMA’s CPT Editorial Panel at the May 2024 meeting.[1]

The LIGHTSITE III clinical trial was a prospective, double-masked, randomized, sham-controlled, parallel group, multicenter clinical trial conducted at ten US retinal centers. The purpose was to assess the safety and efficacy of photobiomodulation treatment in patients with dry age-related macular degeneration (AMD). The primary efficacy endpoint, best corrected visual acuity (BCVA), was evaluated at 13 months and was significantly improved (P<0.025). The trial continued for a total 24 months. The 24-month data showed minimal safety risks and high patient compliance with over 80% of the patients completing the six rounds of Valeda PBM treatment sessions.

The analysis included 91 eyes in the PBM treatment group and 54 eyes in the sham-treatment group in the modified intent to treat population with at least 1 post-treatment visit and disease consistent with early/intermediate dry AMD. 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). Less patients progressed to new geographic atrophy, a later stage scar that is seen with the permanent loss of retinal tissue.

“In parallel with our De Novo submission to the FDA, this is another important step for dry AMD patients experiencing vision loss who currently have limited treatment options. LumiThera wants patients to have access to non-invasive Valeda treatments to improve vision and address the disease earlier in the process,” stated Clark Tedford, Ph.D., LumiThera President and CEO.