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LUMITHERA, INC.
Corporate Headquarters
19578 10th Ave NE STE 200
Poulsbo, Washington 98370
Phone: +1-844-342-3333
Phone: +44-2076601516
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 {> 125μm 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.
Contraindications for Use
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 Light Delivery System User Manual for full Important Safety Information.
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