A novel, easy-to-use hydrogel sealant (OcuPair^TM) for temporary corneal repair

Abstract

Purpose : Traumatic eye injuries often pose a significant risk for blindness in military personnel. The injured eye needs immediate attention and should be temporary stabilized until soldiers are evacuated to operating facilities. For this purpose, we have developed OcuPair^TM hydrogel sealant, a novel dendrimer-hyaluronic acid adhesive for temporary corneal repair and wound stabilization.

Methods : Photo-crosslinkable components of OcuPair, methacrylated dendrimer (D-MA) and methacrylated hyaluronic acid (HA-MA) were synthesized using scale-up amenable protocols and their stability was assessed at different storage temperatures. The gelation kinetics of OcuPair were evaluated using rheology. The performance of OcuPair in sealing different full thickness corneal wounds was evaluated ex vivo in porcine and rabbit eyes. In vivo (non-GLP) performance of OcuPair was evaluated in a rabbit model of corneal injury. GLP toxicity of OcuPair was evaluated in healthy rabbits by using scaled-up engineering batches.

Results : he OcuPair was designed and optimized to form a transparent and flexible hydrogel sealant within 90 seconds of exposure to blue light (365nm, 4W). OcuPair seals full thickness corneal and corneo-scleral wounds (collectively mimicking battlefield injuries) and withstood burst pressures up to 70mmHg in porcine eyes. OcuPair secured different corneal wounds (n=12 each) in rabbits. OCT and seidel test analysis of rabbit eyes demonstrate that OcuPair maintained good anterior chamber structure and normotensive IOP up to 5 days. Clinical assessment indicated the OcuPair is biocompatible with no signs of significant inflammation to corneal tissue. In contrast, cyanoacrylate group demonstrated significant leakage, inflammation, and corneal toxicity. A 28-day GLP ocular toxicity study demonstrated that OcuPair and its components are well tolerated by ocular tissues and do not induce toxicity to the cornea or other ocular tissues. No signs of genotoxicity, pyrogenicity or bacterial reverse mutations were observed with OcuPair.

Conclusions : During medical evacuation of critically injured soldiers, lifesaving efforts are focused on treating other injuries. Unfortunately, this increases the likelihood of enucleation or permanent vision loss. OcuPair is designed to be applied easily and stabilizes the eye during the evacuation. OcuPair may provide the eye a better chance of rehabilitation and preservation of vision.

This is a 2021 ARVO Annual Meeting abstract.