Just over 11 months after submitting a De Novo request for its lead product, LumiThera Inc. announced the FDA has authorized marketing of the Valeda Light Delivery System (LDS) for the treatment of patients with dry age-related macular degeneration (AMD).
We’ll start with the basics: Talk about this system.
This multi-wavelength and non-invasive treatment uses multiwavelength photobiomodulation (PBM) and a light-emitting diode (LED) system with three wavelengths (590 nm, 660 nm, and 850 nm).
What it does: Transfers a non-coherent, eye-safe column of light to deliver treatment to the eye via either an open or closed eyelid.
And how it works: The system takes < 5 minutes for treatment and can be done on a non-dilated pupil.
How many treatments are required?
As we previously reported, nine applications are needed over a 3- to 4-week period, with additional treatments on follow-up visits.
VIDEO SPOTLIGHT: Check out this interview and listen to Glance President Jaclyn Garlich, OD, FAAO and LumiThera President and CEO Clark Tedford discuss the system.
So … what’s the clinical data on this?
Two notable clinical trials are worth knowing about:
- LIGHTSITE I (NCT02725762)
- LIGHTSITE II (NCT03878420)
The findings: Both studies demonstrated sustained improvements in visual benefits and concluded PBM (the Valeda LDS) could be considered a therapeutic treatment option for early to late dry AMD.
- Specifically: The system provided an improvement in best-corrected visual acuity (BCVA) over 24 months > 5 letters or equivalent to a line on the eye chart.
And wasn’t there a third LIGHTSITE study?
Indeed … back in March 2023, the company reported data from the LIGHTSITE III (NCT04065490) trial—which were included in its De Novo request technical package for Class II device designation.
- The crux of those findings: The use of PBM as treatment resulted in a statistically significant slowing of disease progression in patients with early to intermediate dry AMD, including those who might suffer from new geographic atrophy (GA) lesions.
- Not only did the study meet its primary endpoint, but it also found the Valeda LDS to be safe and effective in increasing + maintaining visual acuity (VA).
Go on …
Clinical investigator Glenn Jaffe, MD, of the Duke Reading Center in Durham, North Carolina, noted that the PBM treatment (the Valeda LDS) had a beneficial effect on multiple anatomic biomarkers.
“For example, we looked at whether PBM affected progression to (GA) and found that incident geographic atrophy was reduced in the PBM-treated eyes compared to the sham-treated eyes,” he stated.
The breakdown: 6.8% (Valeda LDS-treated eyes) versus 24% (sham-treated eyes)
And beyond this study?
LumiThera also received funding via a National Institutes of Health (NIH) grant last year to conduct the open-label LIGHTSITE IIIB trial extension among patients who participated in that third LIGHTSITE study.
- However: Data from this trial has not yet been released.
Also: In January 2024, the company kicked off the EUROLIGHT Registry study to evaluate the long-term benefits of the system among dry AMD patients.
So! What’s the significance of this authorization?
As LumiThera has noted, the Valeda LDS is now the first ever FDA-authorized treatment for vision in dry AMD patients.
- Outside the United States: It’s already CE-approved in the European Union.
Plus, the authorization “creates a threshold for this novel class of PBM devices that must show similar clinical and nonclinical performance controls equivalent to the Valeda (LDS),” according to Lori Holder, LumiThera’s vice president, Regulatory Affairs.
Speaking of PBM devices … isn’t there a new CPT code?
There is! The American Medical Association (AMA) approved a new Category III Current Procedural Terminology (CPT) code supporting PBM in July 2024.
At the time, LumiThera referred to the approval as “a positive step toward reimbursement” for PBM use in retina.
Nice! And lastly, when will this system be available for use?
No specific timeframe has been mentioned as of yet … so stay tuned!