Bio-Tissue pursuing investigational new drug for dry eye treatment
Bio-Tissue can proceed with a phase 2 study investigating morselized cryopreserved amniotic membrane and cryopreserved umbilical cord following clearance from the FDA, according to a press release.
TTBT01 is being studied to support regenerative healing in dry eye disease. Because it is a section 351 biologic investigational new drug, TTBT01 will undergo a strict FDA preapproval process involving two randomized phase 3 clinical trials demonstrating safety and efficacy, the release said.
“Our leadership team determined early on that going after a regenerative therapy based on natural human birth tissue to achieve ocular surface optimization would be the right thing to do — affording the company the opportunity to give physicians optimal treatment options to manage common dry eye problems effectively,” Amy Tseng, president, CEO and co-founder of TissueTech, parent company of Bio-Tissue, said in the release.