Long-term Efficacy and Safety of Photobiomodulation in Dry Age-Related Macular Degeneration (LIGHTSITE III: 24-Month Analysis).

Purpose To evaluate the safety and efficacy of multiwavelength photobiomodulation (PBM) in nonexudative (dry) age-related macular degeneration (AMD). Methods LIGHTSITE III employed a double-masked, randomized, sham-controlled, parallel-group, prospective study design. Subjects were enrolled with a diagnosis of dry AMD and treated with multiwavelength PBM (Valeda® Light Delivery System; 590, 660 and 850 nm) or Sham treatment. A treatment series included 9 PBM or Sham treatments delivered 3x/week over 3-5 weeks every 4 months (M) for 24M. Results A total of 148 eyes (100 subjects) with dry AMD were randomized into the study. LIGHTSITE III met the prespecified primary BCVA efficacy endpoint at M21 with a significant difference between treatment groups (p = 0.0036) and a +6.2 letter gain following PBM. At M21, 61.5% of PBM-treated eyes showed ≥5, 23.1% showed ≥10, and 4.4% showed ≥15 letter gains. A favorable safety profile was observed with no signs of phototoxicity. Disease progression to Geographic Atrophy (GA) showed a significant decrease in incidence (Sham, 24.0% vs. PBM, 6.8%; p = 0.007) following PBM treatment at M24. Significant benefit in vision QoL was observed. Conclusions Multiwavelength PBM represents an interventional therapy that restores visual function and has potential disease-modifying effects in intermediate dry AMD.