LumiThera Announces First CPT Code to Report Photobiomodulation Therapy in Retinal Disease – First Step Toward Reimbursement
07 Agosto 2024 - 5:42AM
Business Wire
LumiThera, Inc., a medical device company commercializing a
photobiomodulation (PBM) treatment for ocular damage and disease,
today announced a new Category III CPT code effective January 1,
2025. The AMA’s CPT Editorial Panel considered and approved the
company’s application for a code to report “Photobiomodulation
therapy of retina, single session” at the May 2024 meeting.1
Support for this new Category III code came from many sources;
one was LumiThera’s clinical trial. LIGHTSITE III was a
prospective, double-masked, randomized, sham-controlled, parallel
group, multi-center clinical trial conducted at ten leading 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.
“Establishing a unique CPT code for PBM use in retina is a
positive step toward reimbursement,” stated Kevin J. Corcoran.
Kevin is a Principal for Corcoran & Corcoran, a leading advisor
on reimbursement for ophthalmic products and services. He said,
“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.”
“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.
About AMD
AMD is a leading cause of vision loss for people aged 65 and
older. Losing central vision can make it harder to see faces,
drive, or do close-up work like cooking or fixing things around the
house. The overall prevalence of AMD is estimated to increase
7-fold with age, from 4.2% in those aged 45–49 years, to 27.2% in
those aged 80–85 years. Globally, the prevalence is estimated 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
diagnosing, treating, and monitoring ocular disease and damage
including dry age-related macular degeneration (AMD), a leading
cause of blindness in adults over 65.
LumiThera’s flagship product, the Valeda® Light Delivery System,
uses multiwavelength photobiomodulation to treat dry AMD patients.
Valeda is CE Marked in the EU and is available in select countries
in Latin America. Valeda is not cleared by the Food and Drug
Administration (FDA).
AdaptDx Pro® dark adaptation functional testing technology
enables eye care professionals to detect and monitor AMD three
years before clinical presentation. AdaptDx Pro is available in the
US and Canada.
Diopsys ERG and VEP systems help eye care professionals analyze
the entire pathway for visual and neuro-visual disorders. VEP is
available in the USA and select countries outside the USA. ERG is
only available outside of the USA.
LumiThera’s AMD Excellence Program® provides customer
implementation, training, best practices, and ongoing support
across all brands.
For more information on the Valeda® Light Delivery System please
visit www.lumithera.com. The AdaptDx Pro and Diopsys ERG and VEP
systems are available separately through LumiThera Diagnostics,
Inc. and Diopsys, Inc.
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1 AMA. Summary of action of CPT Editorial
Panel.
https://www.ama-assn.org/system/files/may-2024-summary-of-panel-actions.pdf
Accessed 8/6/24
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Allison Dabney adabney@lumithera.com Senior Director,
Marketing