March 10, 2015

iVeena completes Pre-IND meeting with FDA for BDI-1 and BDI-2.

iVeena completed a pre-IND call with the FDA delineating the clinical development pathway, required elements for the GLP study, and endpoints of a Phase 1/2a trial. The BDI would be treated as a drug and undergo the 505(b) pathway; iVeena would seek approval for treatment of post-cataract inflammation and potentially be the first product for prevention of post-cataract retinal thickening. Only one species GLP toxicology study is needed.