FDA Authorizes Lynch Regenerative Medicine's IND for a Phase IIb Clinical Trial for Injection of rhPDGF-BB for Treatment of Infraorbital Hollowing

Multi-center, randomized controlled study will evaluate the safety and preliminary efficacy of investigational injectable rhPDGF-BB in up to 75 participants

FRANKLIN, Tenn., Oct. 21, 2026 /PRNewswire/ -- Lynch Regenerative Medicine, LLC (LRM), a leader in regenerative aesthetics, today announced that its Investigational New Drug (IND) application for a Phase 2 clinical trial evaluating injectable recombinant human platelet-derived growth factor-BB (rhPDGF-BB) in adults with infraorbital hollowing (IOH) has been authorized by the U.S. Food and Drug Administration (FDA).

IOH is marked by aging-related thinning of the skin, and loss of supporting tissues under the eyes often leading to a less than optimal, tired appearance. LRM's pure PDGF is the most widely used pure, sterile regenerative growth factor worldwide, having been FDA approved multiple times and used in millions of patients across topical, implantable, and injectable medical indications, including in the skin. In this clinical trial, LRM's injectable pure PDGF is being evaluated for its safety and potential to improve IOH through gradual, natural tissue regeneration, with the goal of improving facial appearance.

"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 is a multi-center, randomized, dose-ranging study to evaluate the safety, tolerability, and preliminary efficacy of rhPDGF-BB injection for the treatment of IOH. Primary endpoints include safety and improvement on the Canfield Infraorbital Hollowing Scale at 12 weeks. Additional endpoints include assessments of improvements to the quality of the infraorbital tissue via validated patient reported outcome measures and quantitative image analysis, as well as the pharmacokinetic and immunogenicity profile.

The investigation evaluates an injectable rhPDGF-BB solution. LRM separately markets ariessence pure PDGF+^®, a topical cosmetic product intended to improve the appearance of skin that contains rhPDGF-BB and hyaluronic acid serum, reflecting LRM's broader commitment to advancing rhPDGF-BB across multiple delivery formats. The injectable formulation under investigation represents a separate and distinct clinical program.

"The initiation of this Phase 2 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. We are excited to further evaluate the potential of PDGF in a well-controlled clinical setting and look forward to enrolling patients in this important study," said Dr. Steve Yoelin, board-certified ophthalmologist and Phase 2 Principal Investigator.

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.

About Lynch Regenerative Medicine, LLC
Lynch Regenerative Medicine, LLC., (www.lynchregen.com) is a commercial stage biotech company advancing regenerative medicine through innovative therapies and aesthetic solutions. Founded by regenerative medicine and PDGF pioneer Dr. Samuel Lynch, the Company develops and commercializes recombinant growth factor products across clearly defined therapeutic indications and cosmetic applications. Its therapeutic portfolio includes (Regranex Gel^®), an FDA-approved prescription biologic for promoting the healing of chronic wounds and (GEM 21S^®), an FDA-approved combination product indicated for promoting regeneration of periodontal tissues. LRM also markets ariessence pure PDGF+^®, a cosmetic product introduced just over two years ago, intended to improve the appearance of skin; already hundreds of thousands of people have benefitted from its topical post-procedure use (www.ariessence.com). Through its therapeutics and aesthetics companies, LRM is building a focused regenerative medicine platform grounded in scientific rigor, manufacturing expertise, a commitment to high-quality biologic innovation and improving lives. The Company is headquartered in Franklin, Tennessee.

Contact: EvolveMKD, [email protected]

SOURCE Lynch Regenerative Medicine, LLC