US-based Ocular Therapeutix has secured favourable votes from the ophthalmic devices panel of the FDA for its ReSure sealant, a hydrogel designed for intraoperative management of clear corneal incisions with a wound leak following cataract or intraocular lens placement surgery.
The panel voted to recommend ReSure for approval, after reviewing the data from the ReSure sealant pivotal study, a 488 subject prospective, controlled, multi-centre, randomised clinical trial.
The trial was designed to evaluate safety and effectiveness of ReSure sealant and to establish non-inferiority of the ReSure to a suture in preventing incision leakage from clear corneal incisions within the first seven days following cataract surgery.
The wound leak rate for the ReSure sealant was significantly lower compared with sutures. The ReSure sealant also successfully prevented wound leaks in 95.9% of cases, compared with sutures at a rate of only 65.9%.
In addition, there were only few adverse events compared with suture and it was well-tolerated by patients.
In February, Ocular Therapeutix submitted its premarket approval (PMA) application to the FDA for ReSure sealant, based on the 488-patient pivotal clinical trial.
Ocular Therapeutix president and CEO Amar Sawhney said prior to device application, nearly half of all clear corneal wounds spontaneously leaked in the trial, while the majority of remaining incisions leaked with minimal provocation.
"We are pleased that the panel has recognized this important advance with their vote of confidence and look forward to working with FDA toward approval of the ReSure Sealant," Sawhney added.
The ReSure sealant is a proprietary synthetic hydrogel polymer applied as a liquid that creates a barrier on the ocular surface to protect clear corneal incisions in the immediate post-operative period when wounds are most vulnerable.
If approved, the ReSure Ssalant would be the first and only sealant approved for ophthalmic use in the US.