Lynch Regenerative Medicine (LRM) has received FDA authorization for an Investigational New Drug (IND) application to evaluate injectable recombinant human platelet-derived growth factor-BB (rhPDGF-BB) for infraorbital hollowing. The Phase 2b trial will investigate the growth factor as a potential bioregenerative alternative to traditional tear trough fillers.
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The multicenter, randomized, dose-ranging study will enroll up to 75 adults, assessing safety, tolerability and preliminary efficacy. Primary endpoints include safety and changes in under-eye hollowing at 12 weeks, measured using the Canfield Infraorbital Hollowing Scale.
Unlike conventional fillers, which replace lost volume, injectable rhPDGF-BB is being studied for its potential to stimulate gradual tissue regeneration and improve under-eye contours. The trial will also assess tissue quality, patient-reported outcomes, quantitative imaging, pharmacokinetics and immunogenicity.
The investigational injectable is part of LRM’s broader pure PDGF platform, which also includes ariessence pure PDGF+®, a separately marketed topical cosmetic product. Enrollment is expected to begin within the next few weeks, with the trial intended to establish further evidence on the injectable formulation’s safety and potential efficacy for this aesthetic indication.
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