SEATTLE, August 08, 2024–(BUSINESS WIRE)–LumiThera, Inc., a medical device company marketing photobiomodulation (PBM) therapy for ocular injuries and diseases, today announced a new Category III CPT code that will be effective January 1, 2025. The AMA CPT Editorial Committee has reviewed and approved the company’s request for a code to report “Retinal photobiomodulation treatment, in a single session” at the May 2024 meeting. 1
This request for a new Category III code is supported by numerous sources, including the LumiThera clinical trial. LIGHTSITE III was a prospective, double-blind, randomized, sham-controlled, parallel-group, multicenter clinical trial conducted at ten major U.S. retina centers. The objective was to evaluate 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 assessed at 13 months and improved significantly (p
The analysis included 91 eyes in the PBM treatment group and 54 eyes in the sham treatment group in the modified intention-to-treat population with at least one post-treatment visit and disease consistent with early/intermediate dry AMD. Results demonstrated a statistically significant improvement in the primary endpoint of BCVA at 13 months in the PBM treatment group compared with the sham treatment group (p
“Establishing a single CPT code for PBM use on the retina is a positive step toward reimbursement,” said Kevin J. Corcoran, principal of Corcoran & Corcoran and a leading advisor on reimbursement of ophthalmic products and services, adding, “Not all requests for new CPT codes are successful. Those that are successful, like this one, have the support of professional societies and evidence-based medicine published in the scientific literature.”
“Along with our de novo submission to the FDA, this is another important milestone for patients with dry AMD who are experiencing vision loss and currently have limited treatment options. LumiThera wants patients to have access to Valeda’s non-invasive treatments to improve their vision and treat the disease at an earlier stage,” said Clark Tedford, Ph.D., President and CEO of LumiThera.
About AMD
AMD is a leading cause of vision loss in people aged 65 and over. Loss of central vision can make it difficult to see faces, drive, or perform close-up activities such as cooking or fixing things around the house. The overall prevalence of AMD is estimated to increase sevenfold with age, from 4.2% in those aged 45–49 to 27.2% in those aged 80–85. Globally, the prevalence is expected to increase by 20% between 2020 (195.6 million) and 2030 (243.3 million).
About LumiThera
LumiThera, Inc. is a medical device company focused on the diagnosis, treatment and monitoring of eye diseases and injuries, including dry age-related macular degeneration (AMD), a leading cause of blindness in adults over the age of 65.
LumiThera’s flagship product, the Valeda® Light Delivery System, uses multi-wavelength photobiomodulation to treat patients with dry AMD. Valeda is CE marked in the EU and is available in select Latin American countries. Valeda has not received FDA (Food and Drug Administration) clearance.
AdaptDx Pro ® dark adaptation functional analysis technology enables eye care professionals to detect and monitor AMD three years before its clinical presentation. AdaptDx Pro is available in the United States and Canada.
Diopsys ERG and VEP systems help ophthalmic professionals analyze the entire pathway of visual and neurovisual disorders. The VEP system is available in the United States and select other countries. The ERG system is only available outside the United States.
LumiThera’s AMD Excellence Program ® provides deployment, training, best practices and ongoing support for all brands.
For more information on the Valeda® Light Diffusion System, visit www.lumithera.com. The AdaptDx Pro and Diopsys ERG and VEP systems are available separately from LumiThera Diagnostics, Inc. and Diopsys, Inc.
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Contacts
Allison Dabney
adabney@lumithera.com
Marketing Director
