LumiThera, Inc. released data from its 24-month LIGHTSITE III clinical trial assessing the use of the Valeda Light Delivery System to treat patients diagnosed with dry age-related macular degeneration (AMD).
Tell me about this delivery system.
The Valeda Light Delivery System (LDS) is a multi-wavelength and non-invasive treatment that was the first to be CE-approved in the European Union for dry AMD using photobiomodulation (PBM). It is currently authorized for investigational use only in the United States.
The system uses a light-emitting diode system with three wavelengths (590 nm, 660 nm, and 850 nm) to carry a non-coherent, eye-safe column of light to deliver treatment to the eye via either an open or closed eyelid.
How long does treatment take?
Each treatment is expected to take > 5 minutes, with no need for pupil dilation. Patients are meant to receive treatment nine times across 3 to 4 weeks in order for the system to provide extended benefits.
What happened in the first two LIGHTSITE trials?
LIGHTSITE I (NCT02725762) and LIGHTSITE II (NCT03878420) assessed the use of PBM as treatment for dry AMD. Both studies demonstrated sustained improvements in visual benefits and concluded PBM could be considered a therapeutic treatment option for dry AMD.
Now talk about this trial.
The prospective, double-masked, randomized, multicenter trial enrolled 100 participants with early to intermediate dry AMD across 10 retinal centers in the United States. Each patient received treatment every 4 months, with the last being administered at 21 months and the final follow-up visit at 24 months.
Best-corrected visual acuity (BCVA) was the trial’s primary efficacy endpoint. Analysis was conducted on 91 eyes within the PBM-treated group and 54 eyes in the sham-treatment group.
Eighty percent of participants (80) completed the trial. A sustained and statistically significant improvement was initially observed in the BCVA at Month 13 in the PBM treatment group (compared to the sham treatment group; P = 0.02) as well as in the visual acuity at Month 21.
A mean increase in ETDRS letters score >5.0 letters from baseline was reported at both the 13- and 21-month timepoints in the PBM-treated subjects BCVA (P<0.0001).
At 24 months, the baseline improvement in BCVA for the PBM treatment group was significantly larger than the sham group (5.9 vs 1.0 letters [P = 0.015]). Further, an estimated 58% of PBM-treated eyes achieved a >5.0 letter gain with a mean of 8.5 + 0.5 letter gain.
Optical coherence tomography (OCT) was used to conduct a retinal morphology analysis; 24-month data found that 5.7% of PBM-treated eyes (88 total) had progressed to a new geographic atrophy (GA), while 21.6% of sham-treated eyes (51 total) developed new GA.
Investigators reported that 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 GA lesions.