ReSure Sealant

* A prospective, randomized, parallel-arm, controlled, multicenter, subject-masked study evaluated the safety and effectiveness of ReSure Sealant compared with a 10-0 nylon suture for preventing incision leakage from clear corneal incisions in patients having uneventful clear corneal cataract surgery after which a wound leak occurred. Patients scheduled for routine cataract surgery with no confounding ocular pathology were recruited. Patients were evaluated 1 hour after surgery and at 1, 3, 7, 14, 21, and 28 days. The primary endpoint was the percentage of eyes in which leakage occurred after treatment with ReSure Sealant or suture in the 7 days after surgery.¹

References: 1. Masket S, et al. J Cataract Refract Surg. 2014;40(12):2057-2066. 2. ReSure Sealant [instructions for use]. Bedford, MA: Ocular Therapeutix, Inc; LCN 80-1004-011 Rev D.

Important Safety Information

Warnings

ReSure Sealant should not be used on actively leaking incisions in which a temporary dry ocular surface cannot be achieved.

Do not use in patients who are allergic to FD&C Blue #1.

Precautions

ReSure Sealant is for single-use only; discard open and unused product. Use within 30 minutes of removing the mixing tray from foil pouch.

Prior to application, ensure incision site is not actively leaking; remove any standing moisture from the surrounding ocular surface and incision and ensure the site is dry.

Prophylactic use of ReSure Sealant on corneal incisions without intraoperative leakage was not evaluated in the clinical study.

ReSure Sealant will not replace the need for sutures in certain circumstances, including the need for long-term mechanical support to the incision.

Adverse Reactions

The most commonly reported (≥1%) ocular adverse events that occurred in patients treated with ReSure Sealant in the pivotal trial included: worsening best corrected visual acuity (7%), increase in intraocular pressure (5%), corneal astigmatism (3%), eye pain (3%), posterior vitreous detachment (2%), and anterior chamber inflammation (1%).

Indication

ReSure Sealant is indicated for intraoperative management of clear corneal incisions (up to 3.5mm) with a demonstrated wound leak for which a temporary dry surface can be achieved, in order to prevent postoperative fluid egress from such incisions following cataract surgery with intraocular lens (IOL) placement in adults.

Please see Instructions for Use.

© Ocular Therapeutix, Inc. All rights reserved. ReSure Sealant is a registered trademark of Ocular Therapeutix, Inc. PP-US-RS-0024-V2.

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You are encouraged to report Suspected Adverse Reactions.
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