Bio-Tissue announced that its parent company TissueTech had received clearance from the FDA to proceed with a phase 2 study using morselized Cryopreserved Amniotic Membrane (CAM) and Cryopreserved Umbilical Cord (CUC) investigational new drug (IND) TTBT01. This clearance represents another milestone as the company works to achieve FDA approval for its graft and morselized human birth tissue products as biologics for important clinical indications.
Bio-Tissue is pioneering a pipeline in ocular biologics, as illustrated by the pursuit of morselized human birth tissue product TTBT01 to support regenerative healing in patients with persistent corneal epithelial defect – commonly referred to as dry eye disease. As a 351 biologic IND, TTBT01 will be subject to a stringent FDA preapproval process that includes two randomized phase 3 clinical trials to demonstrate safety and efficacy.
“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,” TissueTech Co-Founder, President and Chief Executive Officer Amy Tseng said in a company news 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 manage common dry eye problems effectively.”
Bio-Tissue’s commercially available product, Prokera, is well recognized as part of the algorithm in achieving ocular surface optimization by reducing ocular surface disorder severity and improving dry eye classification from severe frequent/constant to mild and/or episodic.1 Prokera was cleared by the FDA in 2003 as a 510(k) medical device and contains the only amniotic membrane designated by the FDA that has anti-inflammatory, anti-scarring, and anti-angiogenic properties for the ocular surface.
- Journal of Cataract & Refractive Surgery: May 2019 – Volume 45 – Issue 5 – p 669-684 doi: 10.1016/ j.jcrs.2019.03.023