|[September 19, 2013]
FDA Ophthalmic Devices Panel Favorably Votes for the Resure® Sealant
BEDFORD, Mass. --(Business Wire)--
The Food and Drug Administration's (FDA) Ophthalmic Devices Panel
concluded that ReSure Sealant (Ocular Therapeutix, Inc., Bedford, MA), a
first-of-a-kind medical device in the United States, is safe and
effective for the management of clear corneal wound leaks following
During this meeting, the panel reviewed data from the ReSure Sealant
Pivotal Study, a 488-patient controlled, multi-center, randomized,
prospective clinical trial. For the primary endpoint of prevention of
wound leaks within the first 7 days post-operatively, the ReSure Sealant
demonstrated statistical superiority over sutures. The ReSure Sealant
successfully prevented wound leaks in 95.9% of cases, compared to
sutures at a rate of only 65.9%. Use of the ReSure Sealant was
associated with fewer adverse events when compared to suture and was
well-tolerated by patients.
"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," stated Amar Sawhney,
President and CEO of Ocular Therapeutix, Inc. "Surgeons may overestimate
the integrity of clear corneal incisions and may not consider forces
whichmay be encountered by the wound post-operatively. Suturing has so
far been the best definitive recourse for treating leaking wounds,
however, in this trial the ReSure Sealant was demonstrated to be
superior to sutures for management of wound leaks. Additionally, there
were fewer device-related and total adverse events in the ReSure Sealant
group, thus establishing a strong safety profile. 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
About the ReSure Sealant:
The ReSure Sealant is a synthetic, polyethylene glycol (PEG)-based
hydrogel which is applied as a liquid and gels in situ on the
ocular surface, creating a soft and lubricious surface sealant.
The ReSure hydrogel is designed to stay on the incision in the immediate
post-operative period when wounds are most vulnerable, after which it
hydrolyzes and gently sloughs off in the patient's tears.
About Cataract Surgery:
Cataract surgery is the most commonly performed surgery in the United
States, with approximately 3.5 million procedures conducted annually
(Market Scope, 2008). Clear corneal cataract wound leaks are widely
thought to be a contributing factor to some post-surgical complications.
Presently, ophthalmologists use stromal hydration to close these wounds,
however, recent reports in the literature suggest this method of wound
closure may not be adequate to provide a watertight seal.1
FDA approval of an ophthalmic sealant would provide surgeons a novel
means of wound closure for vulnerable incisions.
About Ocular Therapeutix, Inc.:
Founded in November 2006, 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 intracanalicular plugs for treatment of
glaucoma and post-operative pain and inflammation, injectable depots for
back-of-the-eye diseases, and an ocular sealant.
1. Masket S, Hovanesian JA, et al. Use of a calibrated force gauge in
clear corneal cataract surgery to quantify point-pressure manipulation.
J Cataract Refract Surg. 2013 Apr; 39(4):511-8.
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