The US Food and Drug Administration (FDA) has granted marketing authorisation for LumiThera’s Valeda Light Delivery System to treat dry age-related macular degeneration (AMD).
Valeda is said to offer a best corrected visual acuity (BCVA) improvement equating to more than five letters or one line on an eye chart over 24 months.
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This treatment is aimed at improving vision in dry AMD patients.
LumiThera Regulatory Affairs vice-president Lori Holder said: “The de novo authorisation established Valeda as the first device for treatment of dry AMD patients with vision loss and creates a threshold for this novel class of PBM devices that must show similar clinical and nonclinical performance controls equivalent to the Valeda light delivery system.”
The LIGHTSITE III trial of Valeda in the US had met its primary endpoint and was found to be safe and effective in improving and maintaining enhanced visual acuity.
The data from this trial was submitted to the FDA as part of a technical package with special controls earlier this year.
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By GlobalDataValeda previously received a CE mark in the European Union (EU) and is available in selected Latin American countries.
In January 2024, LumiThera commenced the EUROLIGHT study for individuals with AMD.
The multicentre clinical registry study enrolled between 500 and 1,000 patients who have received photobiomodulation (PBM) treatment within the last three years.
This study will initially involve up to 20 centres across Europe and may expand to other countries outside the EU where Valeda is approved.
The data from the study will be used to support reimbursement in various countries and offer clinical information on the real-world use of Valeda.
