On October 21, 2026, Lynch Regenerative Medicine (LRM) announced it received FDA authorization to advance its developmental injectable growth factor drug into a Phase IIb clinical trial for infraorbital hollowing (IOH).
According to the press release, LRM's recombinant human platelet-derived growth factor-BB (rhPDGF-BB) is the most pure, widely used, sterile regenerative growth factor worldwide.
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The launch follows a 2025 clinical trial published in the Journal of Cosmetic Dermatology[1] that showed topical PDGF significantly improved aesthetic outcomes and patient satisfaction after RF microneedling, outperforming standard post-procedure care across multiple endpoints.
This clinical trial aimed to confirm the safety of LRM’s injectable pure PDGF and whether it can improve IOH through gradual, natural tissue regeneration. In addition to improving facial appearance, LRM hopes to offer a regenerative alternative to conventional tear-trough fillers.
“We are pleased to reach this important regulatory and clinical-development milestone,” said Dr. Samuel Lynch, Founder and Chief Executive Officer. “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 infraorbital hollowing. 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.”
According to the Aesthetic Surgery Journal, IOH is one of the most common cosmetic concerns affecting adults and filler injections have become the most common way to treat that condition. As demand for injectable aesthetic treatments continues to grow, the global dermal fillers market is projected to expand from $5.33 billion in 2026 to $9.3 billion by 2034, according to Fortune Business Insights. It’s within this landscape that LRM is advancing a novel, biologic alternative.
The Phase 2 clinical trial will be registered on ClinicalTrials.gov and is expected to begin enrollment within the next few weeks.
Providers and patients can learn more about Lynch Regenerative Medicine and its clinical trials at www.lynchregen.com.
- https://pubmed.ncbi.nlm.nih.gov/40937942/
