Valeda Ligh System for Dry AMD

Hi Linda, I went to Switzerland to get the 9 treatments of Lumi Thera, since is wasn't approved in the U.S. Result was that I could read one more line on the eye chart. The doctor told me that I should continue treatments in the U.S. in three months. He knew FDA was considering it and thought it would be approved faster than it was. It wasn't. Lumi Thera is all over Europe and other countries, so it is not new. When it was finally approved, I did a search and found a retinologist in Garden Grove, California., who has the Valeda machine and gives the treatments. At the time shortly after approval, there were only two in the U.S. I was he second person; his father was his first (with amazing results). Now they are coming from all over, including Canada. I just finished the 9 treatments; results: my bad eye which was 20/1000 is now 20/159. The good eye remained stable. In Switzerland we paid $1500 for the 9 treatments. When I was researching locations, I saw much higher prices at other places. Here in Garden Grove, Calif., I paid for a year's worth (three 9 Lumi Thera treatments) at $4800. If you divide that by three, it comes out to $1600 per series of 9 treatments.
The treatments are scheduled 3 a week (every other day). For a person with early AMD, they will get a much larger improvement. The treatment takes only 15 minutes, is painless, and has so side effects. Since I am 20/30 in my good eye but with geographic atrophy, I'm wanting to stay stable, so I'll keep it up.
I asked my doctor if he would get the Valeda nachine, and he said no. He doesn't have much faith in it, but the results show great results. I would recommend Lumi Thera to anyone with dry AMD.
If you have any questions, I'll be glad to hear them. Or you can contact the doctor I go to: George L. Mayo, MD FASRS, FACS.
Sincerely, Ellen Clizbe

How do I access the 52 unreads? Ellen Clizbe

Linda, I can tell you my experience with the Valeda system for Phtobiomodulation treatment of dry AMD. A code for treatment with the Valeda light delivery system was formalized by the AMA CPT Editorial Panel, the entity responsible for creating new Category III codes, in May of 2024. The code is 0936T (Photobiomodulation therapy of retina, single session). The FDA authorized the Valeda system for the treatment of intermediate dry AMD in the United States in November of 2024 (It has been used in Europe since 2019). FDA authorization was based on the Lightsite III study, which showed that the majority of patients experienced an improvement in visual acuity following treatment. Results of the extension study, which were presented at Association for Research in Vision and Ophthalmology meeting on May 8, 2025 showed that the benefits of treatment extend out to at least four and a half years. Treatment with Valeda showed improved vision and slowed progression of atrophy and drusen that was statistically significant. I was the first to treat patients commercially in California and am in my sixth month using the system to treat intermediate dry AMD. My experience has been very positive, with the majority of patients having improvement in visual acuity. I have also seen cases of drusen regression. Overall the results that I am seeing exceed those of the Lightsite III study. I believe this to be the case because of the way Lumithera was required to handle data on patients that did not complete the initial study. Visual acuity for patients that did not complete treatments were carried forward as if they completed the study. This means that their visual acuities could not improve because they were not receiving treatment but the data was used to evaluate the effectiveness of the treatment. Even with this handicap, Valeda still achieved statistically significant results.

Thank you so much for all this information. I will revisit this with my Retina Specialist to see if he has changed his mind since we last talked. To my knowledge, it is not being offered yet in Indiana. However, as successful as your results sound, hopefully it will be soon. I also wonder how long it will take for insurances and Medicare to cover the cost. I’m optimistic! Linda