ReSure® Sealant

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.1

Please see Important Safety Information below.

ReSure Sealant is a biocompatible hydrogel which is prepared and applied in approximately 20 seconds,3,4 protecting incisions in the immediate postoperative period by creating a watertight seal when wounds are most vulnerable.6 The hydrogel conforms to the de-epithelialized tissue, adheres to surface irregularities, and gradually sloughs off in tears during reepithelialization, so there is no need for removal.1,6 However, ReSure Sealant may be removed carefully with forceps if necessary.1

Benefits of ReSure Sealant

*In the pivotal trial, ReSure Sealant was not studied in complex cases.

Dr. Terry Kim showing the application of ReSure Sealant following a complex cataract surgery

WARNINGS

ReSure Sealant should not be used on actively leaking incisions in which a temporary dry ocular surface cannot be achieved.1

Do not use in patients who are allergic to FD&C Blue #1.1

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.1

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.1

Prophylactic use of ReSure Sealant on corneal incisions without intraoperative leakage was not evaluated in the clinical study.1

ReSure Sealant will not replace the need for sutures in certain circumstances, including the need for long-term mechanical support to the incision.1

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%).1

Please see full instructions for use.

Application of ReSure Sealant

Application of ReSure Sealant1

 

Clinical Image - Primary unsealed clear corneal incision.

Primary unsealed clear corneal incision.2

 

Clinical Image - ReSure Sealant selectively adheres to the de-epithelialized tissue and seals the wound

ReSure Sealant selectively adheres to the de-epithelialized tissue and seals the wound.2


Images courtesy of Deepinder K. Dhaliwal, MD, LAc, University of Pittsburgh Medical Center.

 

REFERENCES: 1. ReSure Sealant [Instructions For Use]. Bedford, MA: Ocular Therapeutix, Inc.: LCN 80-1004-011 Rev C. 2. ReSure Sealant Master Visual Aid; Ocular Therapeutix, Inc. 3. Mah FS. J Ocul Pharmacol Ther. 2016;32(6):396-399. 4. Food and Drug Administration. FDA Summary of Safety and Effectiveness Data. https://www.accessdata.fda.gov /cdrh_docs/pdf13/P130004b.pdf. Accessed March 29, 2021. 5. Nallsamy N. et al. J Cataract Refract Surg. 2017;43:1010-1014. 6. Masket S et al. J Cataract Refract Surg. 2014;40(12):2057-2066.