The U.S. Food and Drug Administration has cleared TissueTech to proceed with a Phase 2 study using morselized Cryopreserved Amniotic Membrane (CAM) and Cryopreserved Umbilical Cord (CUC) Investigational New Drug (IND) TTBT01, according to a press release.
TTBT01 is being studied to support regenerative healing in patients with persistent corneal epithelial defect
“We have been diligent in building an infrastructure to develop products as biologics under Section 351 of the Public Health Service Act and pursuing the Biologics License Application (BLA) regulatory pathway for several years now,” said TissueTech Co-Founder, President and Chief Executive Officer, Amy Tseng in the press release. “Our leadership team determined early on that going after a regenerative therapy based on natural human birth tissue to achieve Ocular Surface Optimization (OSO) would be the right thing to do – affording the company the opportunity to give physicians optimal treatment options to effectively treat common dry eye problems.”
Read the full press release here.
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