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New Hope for Vision Loss—or Just Another FDA Rush Job?

Winter’s deep freeze isn’t the only thing causing chills this February.

 

A new FDA-approved treatment for macular degeneration is making headlines.

 

The Valeda Light Delivery System, a photobiomodulation (PBM) device designed to slow dry macular degeneration, has just been granted FDA approval.

 

The media is calling it a breakthrough. The FDA is patting itself on the back. Yet there are numerous articles popping up asking the question: Was approval granted too soon?

 

If you ask us, something feels off…

 

Why is the mainstream questioning the approval? Does Big Pharma want to hold off because it hasn’t figured out how to fully profit from it yet?

 

Let’s break it down.

Valeda uses photobiomodulation (PBM)—a technology that applies specific wavelengths of light to stimulate cell repair and reduce inflammation.

It’s been used in sports medicine, arthritis treatments, and wound healing, but this is the first time it’s being marketed for eye health.

The treatment plan consists of:

  • 9 light therapy sessions over 3-4 weeks
  • Repeated every 4 months for 2 years

Sounds promising, right?

See, whenever the FDA rushes through a treatment, you have to ask: Who benefits?

Here are some of the facts that are making us raise our eyebrows…

  • A Tiny Trial: The key trial (LIGHTSITE III) included only 100 patients and 144 eyes—a tiny sample size for an FDA approval.
  • High Dropout Rate: Nearly 24% of placebo patients dropped out, yet there’s no clear explanation why.
  • Inconsistent Data: Details are missing. Were patients’ eyes dilated during treatment? How was compliance monitored?
  • The Placebo Effect: Even sham-treated patients saw some improvement, suggesting the effect may be psychological.
  • Safety Concerns: Reports from China link low-level light therapy to eye damage in children. Could older, vulnerable eyes be at even greater risk?
  • Follow the Money: The treatment requires up to 27 office visits per year—a financial windfall for providers, but an inconvenience for seniors.

So what’s really happening here?

Option 1: The FDA Rushed This Through (Again)

The FDA has a history of green-lighting treatments before they’re fully vetted.

From fast-tracked Alzheimer’s drugs to COVID vaccines pushed through without long-term data, we’ve seen them approve questionable treatments before—only to walk them back later when safety concerns emerge.

Is this another case of the FDA rushing to approve something before we have all the answers?

Option 2: Big Pharma Can’t Figure Out How to Monetize It (Yet)

Unlike drug treatments, which can be mass-produced and sold indefinitely, a light therapy device doesn’t generate the same long-term profits.

Drug companies rake in billions from lifelong prescriptions—but a one-time medical device? Not as lucrative.

Could it be that Big Pharma WANTS us to press pause, not because Valeda is ineffective, but because they haven’t figured out how to control and capitalize on it?

One thing is clear: There’s still a lot we don’t know.

Here at E-Alert, we know the extensive benefits of different kinds of light therapy and have reported on these benefits before. We think this has potential to be a great, natural way to harness the power of light to help your vision. No drugs required.

But we realize more information and studies are needed to confirm these benefits.

So while we wait, you may want to consider some other science-backed, natural ways to support your vision:

  • Eat for Your Eyes: Lutein and Zeaxanthin are found in spinach, kale, and eggs. These nutrients protect your retina. And bilberry extract has been used for centuries to improve night vision and reduce eye strain.
  • Increase Omega-3 Fatty Acids: Wild-caught fish like salmon and sardines help reduce inflammation in the eyes. Walnuts and flaxseeds also provide plant-based omega-3s.
  • Take Eye-Boosting Supplements: Zinc and vitamin C can reduce the risk of AMD worsening by 25% in high-risk patients. Plus, astaxanthin is a powerful antioxidant that protects eyes from oxidative stress.
  • Protect Your Vision Daily: Blue light protection is key. Focus on reducing screen time and use blue-light-blocking glasses. And always wear sunglasses to prevent retinal damage from the sun.

We’re not saying this light therapy doesn’t work.

In fact, it could be a game-changer.

But when the FDA fast-tracks a treatment and Big Pharma hesitates, you have to wonder who’s really in control.

Macular degeneration is serious, and you deserve the best options—not just the ones Big Pharma decides to sell you.

To taking charge of your vision,

Rachel Mace
Managing Editorial Director, e-Alert
with contributions from the research team

Sources:

Kirkner, R. M. (2025, February 3). Was a Novel Eye Treatment Approved Too Soon? Medscape. https://www.medscape.com/viewarticle/was-novel-eye-treatment-approved-too-soon-2025a10002l7

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