If you’ve heard about PDGF, the buzzy growth factor showing up in dermatologist offices, you may have also heard about doctors using it under the eyes. Some are already doing it, even though the treatment isn’t FDA-approved for injection. Now, the company behind ariessence pure PDGF+ is taking the next step toward changing that.
On October 21, Lynch Regenerative Medicine (LRM) announced that the FDA has cleared its Investigational New Drug (IND) application to begin a Phase 2b clinical trial testing injectable PDGF for under-eye hollows. The hope is that instead of just filling in the area, the treatment could help regenerate the tissue that’s been lost with age.
How Is It Different From Under-Eye Filler?
If you’ve ever considered under-eye filler, you know the appeal: add volume to a hollow area and look a little less tired. PDGF takes a different approach.
“A filler fills the space,” explains LRM founder and CEO Samuel Lynch, PhD, “whereas with PDGF, you are truly regenerating the patient’s own tissues.”
The difference is that filler gives you a more immediate result, while PDGF is intended to work gradually. Dr. Lynch says patients could start noticing improvements over six to 10 weeks as the treatment encourages the body’s natural repair process.
That could make it especially appealing for anyone who doesn’t love the idea of filler but still wants to address that hollow, sunken look under the eyes. Researchers will also be tracking whether the treatment improves the overall quality of the under-eye tissue.
Aren’t Some Physicians Already Injecting PDGF?
Yes, and that’s part of what makes this news interesting. Some providers have been using the PDGF from ariessence for off-label injections, including under the eyes. But ariessence is intended for topical use, not injection, and the new injectable is being developed as a separate drug.
Dr. Lynch acknowledges the trend and says the company wants to bring that use through the FDA approval process. “We’re just trying to catch up,” he says, and study it “in a rigorous, tested way that FDA will accept.”
PDGF itself isn’t new. The growth factor has been used in medicine for decades, including in wound healing and tissue regeneration. What’s new is the possibility of an FDA-approved injectable specifically for under-eye hollows.
How Long Would Results Last?
That’s one of the questions researchers are hoping to answer. Dr. Lynch says some providers are already using PDGF as a one-time under-eye treatment, with a second session eight to 12 weeks later if needed. He estimates that improvements could last nine to 18 months, though that hasn’t been confirmed in clinical trials.
The new study will involve up to 75 patients across six clinical sites, with researchers measuring safety and improvements in under-eye hollows at 12 weeks.
When Can You Get It?
Not quite yet. Dr. Lynch expects the current trial to take about a year, after which the company will review the findings with the FDA. A larger Phase 3 trial will likely follow.
“We’re looking at probably at least three years to get the approval for this,” he says.
For anyone following the rise of regenerative aesthetics, it’s another development worth watching. And for patients who’ve been curious about PDGF injections but hesitant because they aren’t FDA-approved, this trial is a step toward finding out whether the treatment is as promising as early experiences suggest.
