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LUMITHERA, INC.
Corporate Headquarters
19578 10th Ave NE STE 200
Poulsbo, Washington 98370
Phone: +1-844-342-3333
LumiThera GMBH
Terminalstr. Mitte 18
85356 München-Flughafen
Deutschland
Phone: +44-2076601516
U.S. Indications for Use
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 μm in diameter), or non-central geographic atrophy, AND The absence of neovascular maculopathy or central-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.
Indications for Use outside the U.S.*
The indicated use is for treatment of ocular damage and disease using photobiomodulation, including inhibition of inflammatory mediators, edema or drusen deposition, improvement of wound healing following ocular trauma or surgery, and increase in visual acuity and contrast sensitivity in patients with degenerative diseases such as dry age-related macular degeneration.
*Indications for use determined by region. Contact LumiThera for more information.
As a precaution, patients have not been tested and should not be treated with Valeda if they have any known photosensitivity to yellow light, red light, or near-infrared radiation (NIR), or if they have a history of light-activated central nervous system disorders (e.g., epilepsy, migraine). In addition, patients should not receive treatment within 30 days of using photosensitizing agents (e.g., topicals, injectables) that are affected by 590, 660, and/or 850 nm light before consulting with their physician.
Refer to the Valeda User Manual for full Important Safety Information.