BUSINESS WIRE
BEDFORD, Mass.--(BUSINESS WIRE)--Ocular
Therapeutix, Inc. announced today that it has submitted its
Premarket Approval (PMA) Application to the U.S. Food and Drug
Administration (FDA) for ReSure Sealant, a novel ophthalmic medical
device that utilizes the company’s proprietary hydrogel technology.
ReSure Sealant was evaluated in a prospective, randomized, parallel arm,
controlled, subject-masked U.S. Pivotal Clinical Trial in which 488
subjects were enrolled at 24 sites throughout the United States. The
study compared the ReSure hydrogel sealant with sutures for safety and
effectiveness within the first 7 days following cataract surgery. The
proposed indication for ReSure Sealant is intraoperative management of
clear corneal incisions with a wound leak as demonstrated by a Seidel
test, and for prevention of postoperative fluid egress following
cataract or intraocular lens placement surgery.
Clear corneal wounds are often closed by hydrating the stroma of the
cornea, which transiently inflates the tissue to more closely oppose the
wound edges. However, evidence suggests these incisions may not be,
and/or do not remain, watertight. Wound leaks are widely believed to
increase the risk of various post-operative complications. “This trial
demonstrated that clear corneal incisions may be more vulnerable than
previously thought, with zero to minimal touch pressure required to
produce a wound leak in 76% of cases,” stated Terry Kim, M.D., Professor
of Ophthalmology, Duke University Eye Center. “More protection may be
necessary to safeguard these incisions, and ReSure Sealant has
demonstrated to be a valuable adjunct to clear corneal cataract surgery
in this trial.”
Cataract surgery is the most commonly performed surgery in the United
States, with well over 3 million procedures conducted annually.1
Pending FDA approval, ReSure Sealant would be the first and only sealant
approved for ophthalmic use. “We are very pleased with the results of
the trial and believe our data set is strong,” stated Amar Sawhney,
President and CEO of Ocular Therapeutix. “Should FDA view our trial
results favorably, we hope to have the opportunity to offer ReSure
Sealant to U.S. clinicians later this year.”
About Ocular Therapeutix, Inc.:
Ocular Therapeutix, Inc. is a privately held company based in Bedford,
MA, focused on the development and commercialization of ophthalmic
therapeutic products using its proprietary hydrogel technology. Ocular
Therapeutix is focusing on development of drug-eluting punctum plugs for
treatment of glaucoma and post-operative inflammation and pain,
injectable depots for back-of-the-eye diseases, and ReSure Sealant for
sealing clear corneal incisions following lens implantation surgery.
1 The Global Cataract Surgery Devices Market is forecast to
exceed $3.8 Billion by 2017. ASDR Reports, February 22, 2012. https://www.asdreports.com/news.asp?pr_id=261.