FDA Approves Clinical Trial for Under-Eye Hollows Treatment

The FDA has cleared a clinical trial for injectable PDGF to treat under-eye hollows, marking a significant advancement in regenerative aesthetics. Lynch Regenerative Medicine (LRM), the company behind ariessence pure PDGF+, announced on October 21 that its Investigational New Drug (IND) application had been approved. This Phase 2b trial aims to test whether PDGF can regenerate lost tissue, offering a potential alternative to traditional fillers by addressing the root cause of under-eye hollows rather than merely masking the issue.

How PDGF Differs From Fillers

Unlike fillers, which add volume temporarily, PDGF injections aim to stimulate the body’s natural repair process, encouraging the regeneration of the patient’s own tissues. Dr. Samuel Lynch, founder and CEO of LRM, emphasizes that PDGF works gradually, with patients potentially noticing improvements over six to 10 weeks. This contrasts with fillers, which provide immediate results. The effects of PDGF could last nine to 18 months, though this duration is still being studied. This approach may appeal to those seeking a more natural, long-term solution to under-eye hollows.

The trial will enroll up to 75 patients across six clinical sites, focusing on safety and effectiveness at the 12-week mark. Researchers will also assess whether PDGF improves the overall quality of under-eye tissue, a key factor in addressing the aging process. This rigorous evaluation is designed to meet FDA standards and establish PDGF as a viable treatment option.

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Off-Label Use and FDA Approval

Some physicians have already been using PDGF for off-label under-eye injections, despite it being intended for topical application. LRM aims to formalize this practice by developing a dedicated injectable product that meets FDA approval. Dr. Lynch acknowledges the existing trend and stresses the importance of studying the treatment rigorously to ensure safety and efficacy. “We’re just trying to catch up,” he says, highlighting the need for clinical validation of this emerging use.

PDGF has a well-established history in medicine, particularly in wound healing and tissue regeneration. This trial represents the first step toward creating an FDA-approved injectable specifically for under-eye hollows, bridging the gap between off-label use and regulatory endorsement.

Timeline and Next Steps

The current Phase 2b trial is expected to take approximately one year, after which LRM will review the findings with the FDA. A larger Phase 3 trial will likely follow, with approval anticipated in at least three years. Dr. Lynch notes that while some providers are already using PDGF as a one-time treatment, with optional follow-up sessions, the trial aims to establish clear guidelines for its use. For those interested in regenerative aesthetics, this development shows the potential of PDGF to transform under-eye treatments.