Ocular Therapeutix closes eye treatment study enrollment ahead of PMA bid
Ocular Therapeutic closes enrollment on a pivotal trail of its ReSure hydrogel sealant, the findings from which will support the company's bid for FDA pre-market approval.
Ocular Therapeutix completed enrollment in a pivotal trail of its ReSure sealant, a hydrogel used to protect ocular incisions following eye surgery.
Findings from the 488-patient study will support the company's bid for pre-market approval for ReSure, aiming for the agency's approval to market the device in treating post-operative corneal wounds.
Applied as a liquid, the product gels to form a barrier on the surface of the eye following cataract surgery, the most common eye surgery performed in the U.S., according to a press release.