An Investigational New Drug (IND) application for Lynch Regenerative Medicine’s phase 2 clinical trial evaluating injectable recombinant human platelet-derived growth factor-BB (rhPDGF-BB) in adults with infraorbital hollowing (IOH) has been authorised by the US 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.
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-centre, randomised, 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 programme.
