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US FDA Approves Phase 2 Clinical Trial of Injectable PDGF for Under-Eye Hollows

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US FDA Approves Phase 2 Clinical Trial of Injectable PDGF for Under-Eye Hollows

THE WHAT? The US Food and Drug Administration (FDA) has cleared Lynch Regenerative Medicine’s Investigational New Drug application for a Phase 2 clinical trial evaluating injectable recombinant human platelet-derived growth factor-BB (rhPDGF-BB) as a treatment for under-eye hollowing.

THE DETAILS The multicentre, randomised trial will assess the safety, tolerability and preliminary efficacy of injectable rhPDGF-BB in adults with infraorbital hollowing. Researchers will measure improvements in under-eye appearance over 12 weeks, alongside tissue quality, patient-reported outcomes and immunogenicity. Patient enrolment is expected to begin within weeks. Lynch Regenerative Medicine also markets ariessence pure PDGF+, a separate topical cosmetic product containing rhPDGF-BB and hyaluronic acid serum.

THE WHY? The development highlights growing interest in regenerative approaches to aesthetic treatments, particularly those targeting skin quality and tissue restoration. While the injectable formulation remains investigational, the trial could provide further clinical evidence for the use of growth factors in aesthetic medicine, a field increasingly connected to advanced skincare innovation.



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