LumiThera’s Valeda Light Delivery System receives marketing authorization from FDA

(Image Credit: AdobeStock/Nima)

LumiThera Inc. announced the US Food & Drug Administration (FDA) has authorized marketing of Valeda Light Delivery System for the treatment of patients with dry age-related macular degeneration (AMD).

According to the company, the Valeda Light Delivery System is the first-ever authorized treatment by the FDA for vision loss in dry AMD patients and provides an improvement in best corrected visual acuity (BCVA) over 24 months of >5 letters or equivalent.¹

LumiThera submitted the LIGHTSITE III (NCT04065490), clinical data as part of a technical package to the FDA under a De Novo request with special controls. In the trial Valeda met its primary endpoint and was shown to be safe and effective in increasing and maintaining improved visual acuity.¹

“The De Novo authorization established Valeda as the first device for treatment of dry AMD patients with vision loss and creates a threshold for this novel class of PBM devices that must show similar clinical and nonclinical performance controls equivalent to the Valeda Light Delivery System,” said Lori Holder, vice president, regulatory affairs, at LumiThera, Inc. in the press release from the company.

The LIGHTSITE III was a prospective, double-masked, randomized, multi-center clinical trial, conducted at 10 leading US retinal centers and enrolled 100 subjects with early to intermediate dry AMD.²

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. The trial initially demonstrated sustained and statistically significant improvement in the primary endpoint, BCVA, at 13 months in the PBM treatment group when compared to the sham-treatment group (p = 0.02). Now, a sustained, mean increase in ETDRS letter score >5.0 letters from baseline is reported at both the 13- and 21-month timepoints in the PBM-treated subjects BCVA (p < 0.0001).²

The improvement from baseline in BCVA at 24 months in the PBM treatment group was significantly greater than in the sham group, 5.9 vs 1.0 letters (p = 0.0015). Approximately 58% of the PBM-treated eyes had >5 letter gain with a mean of 8.5 + 0.5 letter gain.

Glenn Jaffe, MD, Duke Reading Center, commented on the trial in a release from the company.

“The primary endpoint for the study was visual acuity gain,” said Jaffe. “We also followed multiple anatomical endpoints from BL throughout the 24-month study to determine whether photobiomodulation [PBM] helped to preserve retinal anatomy. The PBM treatment had a beneficial effect on multiple anatomic biomarkers. For example, we looked at whether PBM affected progression to geographic atrophy and found that incident geographic atrophy was reduced in the PBM-treated eyes compared to the sham treated eyes respectively, 6.8% versus 24%. Although incident GA was not a prespecified clinical endpoint, the results supported overall safety benefits of treating earlier in dry AMD disease.

Valeda is CE Marked in the EU and is available in select countries in Latin America.

References:

1. LumiThera Obtains FDA Authorization of Valeda Treatment for Dry AMD Patients to Improve Vision. Press Release; November 4, 2024. Accessed November 6, 2024. https://www.lumithera.com/lumithera-obtains-fda-authorization-of-valeda-treatment-for-dry-amd-patients-to-improve-vision/

2. LumiThera announces sustained vision improvement for 24 months in dry AMD clinical trial data. Published March, 2023. Accessed November 6, 2024. https://www.ophthalmologytimes.com/view/lumithera-announces-sustained-vision-improvement-for-24-months-in-dry-amd-clinical-trial-data