OcuPair, a novel photo-crosslinkable dendrimer-hyaluronic acid hydrogel bandage/bioadhesive for corneal injuries and temporary corneal repair
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Traumatic corneal injuries are a leading cause of blindness among military personnel. These injuries need immediate attention at 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 PAMAM dendrimer and hyaluronic acid engineered to form a transparent, flexible and robust bandage within 90 seconds, adhering to 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™ effectively seals complex full thickness wounds and preserves 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.