Topline results from an extension study of the LIGHTSITE III trial is demonstrating promising vision outcomes for dry age-related macular degeneration (AMD) patients treated with LumiThera Inc’s Valeda Light Delivery System (LDS).
The findings were presented during last week’s 2025 annual meeting of the Association for Research in Vision and Ophthalmology (ARVO).
Start with Valeda.
What it is: A non-invasive treatment incorporating photobiomodulation (PBM) and a light-emitting diode (LED) system with three nanometers (nm) wavelengths:
- 590 nm
- 660 nm
- 850 nm
How it works: By transporting a non-coherence, eye-safe column of light that delivers treatment to the eye via an open or closed eyelid—and on a non-diated pupil.
- Treatment duration: < 5 minutes
And how many treatments are needed?
A reported nine applications across a 3- to 4-week period—along with additional sessions as needed on follow-up visits.
Got it. So what’s its regulatory status?
The system was granted De Novo authorization by the FDA in November 2024, making it the first PBM treatment device of its kind authorized to treat vision loss among dry AMD patients.
Prior to that: The American Medical Association approved a new Category III Current Procedural Terminology (CPT) code supporting PBM treatment—a major win for LumiThera, who submitted an application for the code.
Now let’s get into its clinical data.
The Valeda has been evaluated in the LIGHTSITE clinical program, consisting of three studies:
- LIGHTSITE I (NCT02725762)
- LIGHTSITE II (NCT03878420)
- LIGHTSITE III (NCT04065490)
The findings from those:
- The first two trials indicated the system was associated with sustained improvements in visual benefits among dry AMD patients
- The third trial (LT3) found the use of PBM resulted in a statistically significant slowing of disease progression among patients with early to intermediate dry AMD
- Specifically: The data demonstrated a “significant improvement in BCVA,” with the primary endpoint BCVA benefit translated to + 6.2 letters at Month 21 in the PBM group (p = 0.0036).
And how does this latest data compare to those findings?
In a nutshell: The newly-presented topline data from the LIGHTSITE IIIB extension trial displayed extended vision improvements among dry AMD patients.
But first, a few details on this study.
- The design: Open-label, prospective, multicenter extension study (NCT06229665)
- The participants: 36 patients (63 eyes; age 50+) diagnosed with dry AMD
- These were also participants who completed the LT3 study, of which:
- 38 eyes previously treated with the Valeda system (PBM)
- 15 eyes previously treated with sham
- 9 eyes referred to as “non-study (NS) eyes” with no previous treatment
- These were also participants who completed the LT3 study, of which:
- The setup: All patients were treated with the Valeda LDS for a total of nine treatments over a 3- to 5-week period (preferably 3 times per week for 3 weeks)
- To note: A re-treatment period starting at the 4-month mark includes nine additional treatments, repeated again at the 8-month and 12-month mark
- Wavelengths settings (two alternating and sequential treatments) used on the system mirrored those from the LT3 trial
- 590 nm and 850 nm for 35 seconds
- 660 nm for 90 seconds
- Wavelengths settings (two alternating and sequential treatments) used on the system mirrored those from the LT3 trial
- To note: A re-treatment period starting at the 4-month mark includes nine additional treatments, repeated again at the 8-month and 12-month mark
- The duration: 13 months
- Note: This interim review was based on available data extending out from 5 months
And what was measured?
Measured at 12 months:
- The primary outcome measure included Early Treatment Diabetic Retinopathy (ETDRS) best-corrected visual acuity (BCVA), as determined via mean change from baseline in BCVA
- And the secondary outcomes measures extended to:
- Low-luminance BCVA
- Contrast sensitivity (mean change at 80 cm and 120 cm)
- Geographic atrophy (determined via the number of new onset GA among patients)
Next: the findings.
First: The average time since patients had ended their involvement (baseline visits) in the LT3 study was 599 days.
As for the baseline BCVA scores. These ranged between 65 and 75 letters across all groups (Snellen 20/32 – 20/50).
How much vision was lost between LT3 and the extension?
From the last visit (at Month 24) of the LT3 study to the baseline visit in the extension trial, vision loss among all three patients groups was:
- -2.2 letters for PBM-treated eyes
- -2.8 letters for NS eyes
- -5.7 letters for sham-treated eyes
Interesting … and after a few months into the extension?
At Month 5 (following two series of PBM treatments), investigators reported a BCVA gain among all three patient groups—with the highest noted in the treatment naïve NS group.
The numbers:
- +5.1 letters for NS eyes
- +2.2 letters for PBM-treated eyes
- -2.8 letters for sham-treated eyes
And the final numbers for those eyes previously treated with PBM?
A mean gain of 5.5 BCVA letters was noted after eight series of PBM treatment with the Valeda LDS (3.7 years [1,353 days] from the initiation of initial treatment).
So! What does all of this mean?
In a clinical abstract of the findings, investigators wrote that the data “further extends the beneficial impact” of the Valeda LDS’s PBM efficacy on BCVA— “especially when initiated in early to intermediate dry AMD patients.”
And in LumiThera’s announcement of these findings, President and CEO Clark Tedford, PhD, noted: “The extended trial results demonstrate that Valeda is potentially modifying the trajectory of vision loss in dry AMD patients and can offer sustainable benefits over several years with continued treatment.”