OcuPair, a Novel Photo‐crosslinkable PAMAM Dendrimer‐Hyaluronic Acid Hydrogel Bandage/Bioadhesive for Corneal Injuries and Temporary Corneal Repair
Siva P. Kambhampati, Rishi Sharma, Hui Lin, Santiago Appiani, Jeffrey L. Cleland, Samuel C. Yiu, Rangaramanujam M. Kannan
Abstract
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.