OcuPair^TM: A novel dendrimer-hyaluronic acid hydrogel sealant for temporary corneal wound stabilization

Abstract

Purpose : Battlefield related traumatic eye injuries (TEI) are one of the leading causes of blindness in military personal. Full-thickness corneal wounds and hypotony are the complications that require immediate attention and temporary stabilization until the military personnel is evacuated to the operating facilities. We have developed a novel, two-component system (OcuPair^TM) for temporary corneal wound/globe stabilization.

Methods : The first component is an injectable filler gel comprising of sterile 2% hyaluronic acid. The second component is an adhesive hydrogel comprising of methacrylated hydroxyl dendrimer (D-MA) and methacrylated hyaluronic acid (HA-MA), each of which was synthesized using multi-step synthesis protocol. The sealing capacity of the adhesive hydrogel for different corneal wounds were accessed ex vivo in fresh porcine eyes. The performance of OcuPair^TM was evaluated in rabbits with different full-thickness wound architectures (6mm linear, 3.5 mm stellate, 4.5 mm circular and 6mm corneoscleral incisions) (n=12 for each).

Results : At appropriate ratios of HA-MA:D-MA the adhesive hydrogel forms a flexible and transparent sealant within 90 seconds of blue light application. Upon application, the adhesive hydrogel seals the corneal incisions rapidly and withstands increasing IOP >70 mmHg. The transparent OcuPair^TM secures different corneal wounds immediately, resulting chamber formation within 24 hrs with good corneal adherence up to 5 days. Clinical assessment indicates the adhesive hydrogel is compatible to cornea and does not inflict any significant signs of inflammation. Cyanoacrylate group, in contrast, demonstrates early dislodgment with significant signs of corneal inflammation.

Conclusions : After the evacuation of the injured military personnel from the warzone, much of the life-saving efforts are focused on treating other injuries. Ocular trauma may be overlooked, resulting in delayed treatment, poor visual outcome or vision loss. OcuPair^TM is effective in temporary corneal wound/globe stabilization until more permanent intervention can be applied by the corneal surgeon. Scale-up synthesis and IND enabling studies are underway. Potential trials for temporary corneal wound stabilization following traumatic eye injuries will enable broad application of the device in corneal injuries.

This is a 2020 ARVO Annual Meeting abstract.

 

Ex vivo and in vivo performance of OcuPair^TM for temporary corneal/globe stablization