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The Valeda Light Delivery System is intended to provide improved visual acuity in patients with best-corrected visual acuity of 20/32 through 20/70 and who have dry age-related macular degeneration (AMD) characterized by: - . The presence of at least 3 medium drusen (> 63 µm and ≤ 125 µm in diameter), or large drusen (> 125 um in diameter), or non-central geographic atrophy, AND - The absence of neovascular maculopathy or center-involving geographic atrophy. ● After about two years, the Valeda Light Delivery System treatment provides improved mean visual acuity of approximately one line of visual acuity (ETDRS) compared to those not receiving the treatment.

The Valeda Light Delivery System is a benchtop instrument emitting non-coherent light in the wavelengths of 590 nm (amber), 660 nm (red), and 850 nm (near infrared, i.e., NIR) from three light emitting diodes (LEDs). respectively. The system projects a beam spot with a diameter of approximately 30 mm at the corneal plane of the patient for each of the three wavelengths. The system is to be used by eye care professionals to treat certain population of patients with dry AMD as defined in the Indications for Use (IFU). The operator interface (Operator View in Figure 1) consists of a touchscreen, start and stop buttons and a joystick to center the beam on the patient's eye. A USB port is used to load treatment credits into the system. The patient interface (Patient View in Figure 1) consists of a fixed forehead rest, the light aperture (exit window) and an adjustable chin rest. Each treatment takes a total of 250 seconds and consists of four phases as described below. - 1) Open Eye: Pulsed amber (590 nm, 3 Hz) and NIR (850 nm, 3 Hz) LEDs are turned on for 35 seconds. - 2) Closed Eye: Continuous red LED (660 nm) is turned on for 90 seconds. - 3) Open Eye: Pulsed amber (590 nm, 3 Hz) and NIR (850 nm, 3 Hz) LEDs are turned on for 35 seconds. - 4) Closed Eye: Continuous red LED (660 nm) is turned on for 90 seconds. For each treatment series, the patient receives 3 treatments each week for a total of 9 treatments over a period of 3-5 weeks.