Regenerative aesthetics company Lynch Regenerative Medicine LLC (LRM) announced on Wednesday 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 authorised by the US Food and Drug Administration (FDA).

The multi-centre, randomised, dose-ranging study is designed 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 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.

This 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.

Enrolment in the Phase 2 clinical trial is expected to begin within the next few weeks.