The US Food and Drug Administration (FDA) has authorised Lynch Regenerative Medicine’s investigational new drug (IND) application for a Phase II study of injectable recombinant human platelet-derived growth factor-BB (rhPDGF-BB) to treat adults with infraorbital hollowing (IOH).
IOH is characterised by the thinning of skin and the loss of underlying tissue support below the eyes due to ageing, which can create a tired appearance.
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The randomised, multi-centre, dose-ranging trial is designed to assess the tolerability, safety, and early efficacy of rhPDGF-BB injection.
Its primary endpoints consist of safety outcomes and changes recorded on the Canfield Infraorbital Hollowing Scale at 12 weeks.
Secondary endpoints will evaluate tissue quality via validated patient-reported outcomes and quantitative imaging, as well as pharmacokinetic and immunogenicity profiles.
Lynch Regenerative Medicine founder and CEO Dr Samuel Lynch said: “We are pleased to reach this important regulatory and clinical-development milestone. rhPDGF-BB has been tested and used extensively in other therapeutic medical settings for decades, and this trial is an important step in our development to rigorously evaluate its safety and efficacy when administered by injection for IOH.
“We believe that biologic approaches resulting in regeneration of the patient’s own tissue are far preferable to injection of fillers and represent an important area of innovation in aesthetics. This trial continues our ongoing commitment to rigorous scientific evaluation of the potential of our pure PDGF platform in regenerative medicine applications.”
Board-certified ophthalmologist Dr Steve Yoelin will serve as a principal investigator for the trial.
Yoelin said: “The initiation of this Phase II study marks an important milestone in the clinical development of injectable PDGF for the bioregenerative treatment of infraorbital hollows.
“Patients and practitioners continue to seek safe, effective, and durable bioregenerative options for improving volume deficiency and contour irregularities in the tear trough region.”
The injectable candidate represents a distinct clinical programme separate from the company’s commercial cosmetic offering, ariessence pure PDGF, which combines rhPDGF-BB with hyaluronic acid serum.
