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On (b)(6) 2025, lumithera became aware of a patient reported event that the reporter attributed to the valeda light delivery system.The reporter described the event as follows: on (b)(6) 2025 i began a 9 treatment session of light therapy using the valeda light system as recommended by my eye doctor of six years.Prior to this treatment, my eyesight was very good and i was being monitored for mild to moderate dry, age-related macular degeneration (amd).My doctor recommended this light therapy to help reduce the risk of future eye damage.Within the first week or two of treatment, i began to notice some changes in my vision but had attributed it to my reading glasses.By the third week of treatment, i notice significant waviness in my window blinds, my tv screen and finally the eye test grid i possessed.The following day, (b)(6) 2025, i saw my eye doctor who informed my that my dry amd had converted to wet amd and that i would need eye injections every month going forward in my life.I was never informed that this could be a possible side effect and was also told that the fda recently determined this treatment to be safe.The only side effect discussed was a temporary photostress afterimage after treatment.I subsequently read a research report pertaining to valeda light system in which it was found that 5.4 percent of a treated group experienced conversion to wet amd, compared to 1.8 for a sham group.None of this was discussed with me prior to treatment.I now have permanent damage to my eye due to this treatment and encourage the fda to require further testing so that others do not experience the same outcome.This event was not reported to lumithera directly prior to receipt of the medwatch form from fda.
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Lumithera has reviewed the data provided and does not believe the event to be related to the device.Age-related macular degeneration (amd) is a common eye disease that affects the macula, the part of the retina responsible for central, detailed vision.There are two forms of amd: dry amd (the early, more common form) and wet amd (the advanced form, which causes faster vision loss).Dry amd develops slowly as small yellow deposits, called drusen, form under the retina.Over time, the retinal cells may become damaged, and central vision can gradually decline.Straight line may appear curved or distorted.Objects may appear to have a dark shadow on the center otherwise called scotomas.While many people live for years with only the dry form, it can progress to wet amd, where abnormal blood vessels grow beneath the retina and cause rapid and profound vision loss.The change from dry to wet amd [called conversion] is part of the disease's natural progression.Research shows: · about 2-4% of patients each year with intermediate dry amd develop the wet form.· over five years, roughly 10-20% will convert.· if one eye already has wet amd, the other eye is at much higher risk, with about 10-12% converting per year.These numbers highlight that moving from dry to wet amd is a natural and relatively common course as the disease advances, especially in patients with larger drusen, pigment changes, or previous wet amd in one eye.Smoking, high blood pressure, and older age are also risk factors for conversion from dry to wet amd.Photobiomodulation (pbm) delivered by the valeda light delivery therapy uses specific wavelengths of light to stimulate cellular activity and improve energy metabolism in retinal cells.Pbm is not authorized to treat wet amd.In a recent 24-month pivotal clinical study in early/intermediate dry amd subjects that included 100 patients (148 study eyes and 52 non-study eyes); nine study eyes developed wet amd: · 2 eyes (3.6%) in the sham-treated group · 7 eyes (7.5%) in the pbm-treated group · additionally, 3 non-study eyes (8.3%) converted during the study period.More patients in the pbm group started the study with higher-risk characteristics - specifically already having wet amd in the other eye (12 pbm vs.4 sham).Of the eyes that converted, two-thirds (67%) were from this high-risk group.This higher risk of patients which started the study in the pbm treated group may explain the numerically higher rate of conversion to wet amd in this group.In this 2-year pivotal rct clinical study, the conversion to wet amd for the pbm-treated and control (sham) groups were within what is expected for conversion to wet in the patient population.On average, conversion to wet amd occurred on average 79 days following the last pbm treatment and on average 54 days following the last control (sham) treatment.References: ladd et al.Monitoring for wet amd in the fellow eye.Available from: https://retinatoday.Com/articles/2021-may-june/monitoring-for-wet-amd-in-the-fellow-eye ross et al.Conversion rates from non-exudative to exudative age-related macular degeneration: an aao iris registry analysis.Iovs june 2022, vol.63, 3118.Sadeghi et al.Incidence and risk factors of fellow-eyes wet conversion in unilateral neovascular age-related macular degeneration over 15-years follow-up.Iovs june 2024, vol.65, 2792.Starr et al.Characteristics of fellow eye conversion to neovascular age-related macular degeneration in patients with unilateral neovascular disease.Presented during the asrs 2020 virtual annual meeting, july 24-26, 2020.Yim et al.Predicting conversion to wet age-related macular degeneration using deep learning.Nature medicine volume 26, 892-899 (2020).Spalton, d.J., and j.Shilling."the retina: macular diseases and retinal dystrophies." atlas of clinical ophthalmology, edited by d.J.Spalton, r.A.Hitchings, and p.A.Hunter, 2nd ed., chap.16, mosby, 1993.
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