{"url":"https://newsforagent.com/news/2026-10-21/lynch-regenerative-medicine-fda-phase-2-trial","markdown_url":"https://newsforagent.com/news/2026-10-21/lynch-regenerative-medicine-fda-phase-2-trial.md","title":"Lynch Regenerative Medicine Wins FDA Nod for Phase 2 Trial","headline":"Lynch Regenerative Medicine's rhPDGF-BB IND Authorized for Phase 2 Infraorbital Hollowing Trial","description":"Lynch Regenerative Medicine's IND for injectable rhPDGF-BB in infraorbital hollowing was authorized, clearing a Phase 2 trial of up to 75 participants.","section":"Regulation & Approvals","published_at":"2026-10-21T18:45:24+00:00","modified_at":"2026-10-21T18:45:24+00:00","author":"News Desk","key_takeaways":["The FDA authorized Lynch Regenerative Medicine's IND for a Phase 2 trial of injectable rhPDGF-BB in adults with infraorbital hollowing.","The multi-center, randomized, dose-ranging study will evaluate safety and preliminary efficacy in up to 75 participants.","Primary endpoints include safety and improvement on the Canfield Infraorbital Hollowing Scale at 12 weeks."],"companies":[{"name":"Lynch Regenerative Medicine","is_primary":true,"profile_url":"https://akta.pro/company-profiles/00031g2/lynch-regenerative-medicine","website":"https://www.lynchregen.com"}],"source":{"publisher":"PR Newswire","title":"FDA Authorizes Lynch Regenerative Medicine's IND for a Phase IIb Clinical Trial for Injection of rhPDGF-BB for Treatment of Infraorbital Hollowing","url":"https://www.prnewswire.com/news-releases/fda-authorizes-lynch-regenerative-medicines-ind-for-a-phase-iib-clinical-trial-for-injection-of-rhpdgf-bb-for-treatment-of-infraorbital-hollowing-302914680.html"},"other_sources":[],"tags":["Regulation & Approvals","Lynch Regenerative Medicine"],"body_markdown":"[Lynch Regenerative Medicine](https://akta.pro/company-profiles/00031g2/lynch-regenerative-medicine) said on October 21, 2026 that the U.S. Food and Drug Administration authorized its Investigational New Drug application for a Phase 2 clinical trial of injectable recombinant human platelet-derived growth factor-BB in adults with infraorbital hollowing. The Franklin, Tennessee-based regenerative medicine company announced the authorization in a [PR Newswire](https://www.prnewswire.com/news-releases/fda-authorizes-lynch-regenerative-medicines-ind-for-a-phase-iib-clinical-trial-for-injection-of-rhpdgf-bb-for-treatment-of-infraorbital-hollowing-302914680.html) release.\n\n## Lynch Regenerative Medicine's Phase 2 Trial Design\n\nThe Phase 2 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 infraorbital hollowing, according to the company. 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.\n\n\"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.\"\n\nDr. Steve Yoelin, board-certified ophthalmologist and Phase 2 Principal Investigator, said the study marks an important milestone in the clinical development of injectable PDGF for the bioregenerative treatment of infraorbital hollows. The company said the trial will be registered on ClinicalTrials.gov and is expected to begin enrollment within the next few weeks.\n\n## Lynch Regenerative Medicine's Funding and Product Portfolio\n\nLynch Regenerative Medicine is a Franklin, Tennessee-based regenerative medicine company founded in 2023 that commercializes three FDA-approved PDGF-BB products across wound care, dental bone grafting, and medical aesthetics, according to akta.pro [company records](https://akta.pro/company-data). The same records show total funding of $22.5 million, with a $15 million round in July 2026, a $3.8 million Series A in July 2024 led by Champion VC, and a $3.8 million round in January 2024.\n\n## What Comes Next for the rhPDGF-BB Program\n\nThe company said 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://www.lynchregen.com).\n","publisher":{"name":"News for Agent","url":"https://newsforagent.com"}}