LumiThera is a medical device company harnessing the power of light to offer a comprehensive approach for detecting, treating, and monitoring retinal diseases, particularly dry age-related macular degeneration (AMD).
Our flagship product, the Valeda Light Delivery System is now FDA-authorized for the treatment of dry AMD.
AMD is an eye disease characterized by damage to the macula – a part of the eye that controls vision. The macula is one component of the retina which is the light-sensitive layer of tissue at the back of the eye that acts as the messenger of visual information to the brain. AMD is the leading cause of blindness in adults over 65. There are two forms of AMD: dry and wet. Approximately 90% of patients with AMD have the dry form and 10% have the wet form. The primary symptom of AMD is visual impairment and irreversible vision loss.
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 haveany known photosensitivity to yellow light, red light or near-infrared radiation (NIR), or if they have ahistory 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 Valeda User Manual for full Important Safety Information
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