OcuPair, a Novel Photo-crosslinkable PAMAM Dendrimer-Hyaluronic Acid Hydrogel Bandage/Bioadhesive for Corneal Injuries and Temporary Corneal Repair.

Abstract

Traumatic corneal injuries are a leading cause of blindness among military personnel. These injuries need immediate attention in the combat zone, but treatment options are limited as life-saving measures are often prioritized. To address this critical gap, we have developed OcuPair^TM, a two-component hydrogel system that consists of i) an injectable viscoelastic filler that stabilizes the ocular cavity and prevents hypotony. ii) An in situ photo-curable adhesive hydrogel comprising of methacrylated, hydroxyl PAMAM dendrimer and hyaluronic acid engineered to form a transparent, flexible, and robust bandage within 90 seconds, adhering to the corneal surface and ensuring a water-tight seal securing full-thickness corneal wounds. Ex vivo studies demonstrated that the adhesive hydrogel is mechanically robust and withstands intraocular pressures beyond physiological range. In a rabbit corneal injury model, OcuPair^TM effectively sealed complex full-thickness wounds and preserved the eye with favorable clinical outcomes for 5 days with no toxicity over 30 days. In this study, we have validated the pilot scale synthesis, formulation optimization, GMP scale-up, and IDE-enabling GLP toxicity, essential for clinical translation as a battlefield-ready solution.