This short page is for colleagues who want to discuss a Valeda evaluation for a patient with dry AMD, or who want a plain-language handoff for patients who will read the rest of this site.

FDA labeling, briefly

Valeda is a Class II, prescription, light-based device. The FDA granted De Novo authorization DEN230083 on November 4, 2024. The indications are quoted on Valeda photobiomodulation and in the decision summary. In short, the authorized population is people with dry AMD, BCVA 20/32 through 20/70, specified drusen or non-central geographic atrophy, and no neovascular maculopathy or center-involving geographic atrophy. The authorized average result is approximately one line of ETDRS visual acuity after about two years, compared with no treatment.

LIGHTSITE III design and both the FDA and journal analyses are summarized on LIGHTSITE III. Please note the FDA comment that incident geographic atrophy was not a pre-specified endpoint.

The decision summary also asks practitioners to consider subgroups that were excluded or under-represented, a fellow eye with neovascular AMD (close monitoring), and the possibility that benefit may not persist significantly after treatment stops.

How to refer

For general questions and written referrals, use Hazleton Eye Specialists: phone 570-453-2020, fax 570-453-1020, or email hesstaff@drkislan.com. Please do not include unnecessary patient identifiers in email; our team can call to gather details securely.

For privacy, please don’t include patient names or other identifying details in email. Our team will call to schedule and gather details securely.

Patients can book an exam at one of the five Eye Specialists of NEPA offices. Please label the visit as an exam or evaluation unless you have confirmed that the scheduler can reserve a Valeda series.

Book an exam

You can choose your office and book an exam online, or call Hazleton Eye Specialists at 570-453-2020.

Sources

• U.S. Food and Drug Administration. DEN230083 and decision summary.

Medical disclaimer. This page is for general education only. It is not medical advice and does not replace an examination or a conversation with your own doctors. Do not start, stop, or change any medicine or treatment without talking to the clinician who cares for you. If you notice new wavy lines, a sudden blur, or a blank spot in your central vision, seek same-day care from an eye doctor or an emergency department.