FDA Authorizes Phase 2 Clinical Trial
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Lynch Regenerative Medicine, LLC (LRM), a biotechnology company focused on regenerative medicine and aesthetics, announced that the US Food and Drug Administration (FDA) has authorized its Investigational New Drug (IND) application.
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The application covers a Phase 2 clinical trial of injectable recombinant human platelet-derived growth factor-BB (rhPDGF-BB) in adults with infraorbital hollowing (IOH).
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The study will evaluate the safety, tolerability, and preliminary efficacy of the investigational treatment.
Understanding Infraorbital Hollowing
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Infraorbital hollowing is characterized by age-related skin thinning and the loss of supporting tissues beneath the eyes.
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The condition can create a tired appearance and contribute to volume deficiency and contour irregularities in the tear trough region.
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Dermal filler injections are commonly used to address this concern.
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LRM is investigating a biologic approach designed to support gradual tissue regeneration as a potential alternative to conventional fillers.
Investigational rhPDGF-BB Treatment
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LRM's injectable rhPDGF-BB formulation is being evaluated for its potential to improve the appearance of infraorbital hollows through tissue regeneration.
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The treatment is designed to be assessed in a controlled clinical setting to establish its safety and efficacy for this specific indication.
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According to Dr. Samuel Lynch, Founder and Chief Executive Officer of LRM, the study represents an important milestone in evaluating the company's pure platelet-derived growth factor platform for regenerative aesthetic applications.
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The company aims to investigate whether biologic approaches can offer an alternative to filler-based treatments.
Phase 2 Clinical Trial Design and Endpoints
The Phase 2 study is designed as a multicenter, randomized, dose-ranging clinical trial.
Key study features include:
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Study design: Multicenter, randomized, dose-ranging trial.
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Investigational treatment: Injectable rhPDGF-BB solution.
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Study population: Adults with infraorbital hollowing.
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Primary endpoints: Safety and improvement in the Canfield Infraorbital Hollowing Scale at 12 weeks.
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Additional assessments: Infraorbital tissue quality, patient-reported outcomes, and quantitative image analysis.
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Other evaluations: Pharmacokinetic and immunogenicity profiles.
These assessments will help researchers characterize the treatment's safety and determine its preliminary efficacy in improving infraorbital hollowing.
Company Highlights Potential of Regenerative Aesthetics
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Dr. Steve Yoelin, a board-certified ophthalmologist and the Phase 2 Principal Investigator, described the study as an important step in evaluating injectable PDGF for the bioregenerative treatment of infraorbital hollows.
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The research will examine the potential of rhPDGF-BB to address volume deficiency and contour irregularities in the tear trough region.
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The company plans to evaluate the investigational treatment through a well-controlled clinical study.
Distinction Between Injectable rhPDGF-BB and ariessence pure PDGF+®
LRM separately markets ariessence pure PDGF+®, a topical cosmetic product containing rhPDGF-BB and hyaluronic acid serum, intended to improve the appearance of skin.
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The topical cosmetic product and the investigational injectable formulation are separate products.
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The injectable rhPDGF-BB formulation is being studied under a distinct clinical development program for infraorbital hollowing.
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Findings from the Phase 2 trial will be important in assessing the injectable formulation's safety and potential effectiveness for this indication.
Clinical Trial Enrollment and Next Steps
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The Phase 2 clinical trial is expected to be registered on ClinicalTrials.gov.
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Patient enrollment is expected to begin within the next few weeks, according to the company announcement.
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The study will generate clinical data on the safety, tolerability, and preliminary efficacy of injectable rhPDGF-BB for infraorbital hollowing.
Further information about Lynch Regenerative Medicine and its clinical trials is available at www.lynchregen.com.
About Lynch Regenerative Medicine, LLC
Lynch Regenerative Medicine, LLC, headquartered in Franklin, Tennessee, is a commercial-stage biotechnology company developing regenerative medicine therapies and aesthetic products.
Its portfolio includes:
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Regranex Gel®: An FDA-approved prescription biologic used to promote the healing of chronic wounds.
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GEM 21S®: An FDA-approved combination product indicated for promoting the regeneration of periodontal tissues.
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ariessence pure PDGF+®: A topical cosmetic product intended to improve the appearance of skin.
Founded by Dr. Samuel Lynch, the company focuses on recombinant growth factor products across therapeutic and cosmetic applications, with an emphasis on scientific evaluation, manufacturing expertise, and regenerative medicine innovation.
