Abstract
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 OcupairTM, 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.
Competing Interest Statement
The authors have awarded and pending patents relating to the hydroxyl dendrimer platform (R.M.K., and S.P.K.) and dendrimer-bioadhesive polymer hydrogel for ocular applications (R.M.K., S.P.K., and S.C.Y.). R.M.K., and his wife (Sujatha Kannan) are co-founders and have financial interests in Ashvattha Therapeutics; a start-up translating dendrimer-drug delivery platform. J.L.C. is the president and CEO of Ashvattha Therapeutic Inc. R.S., and S.A. were full-time employee of Ashvattha Therapeutic Inc. All other authors declare no competing or conflict of interests.
