2014 Issues   /   Pharmacy

First Gel Approved for Sealing Corneal Incision in Cataract Surgery

By U.S. Medicine

BEDFORD, MA — The first gel sealant has been approved to stop leaking fluid through the corneal incision after cataract surgery with intraocular lens placement. Until the Food and Drug Administration approved the ReSure Sealant Kit,  stitches were the only option for closing a leaking corneal incision after cataract surgery. “The FDA has approved gels like ReSure for sealing small incisions in other parts of the body, such as the lungs, but this is a first-of-its-kind for the eye,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. The ReSure Sealant Kit, which comes as two liquid solutions that must be mixed together, is applied directly to the incision using a foam-tipped applicator provided in the kit. Within 20 seconds of applying the liquid to eye tissue, a gel forms that adheres to the eye and seals the incision. After seven days, the gel gradually breaks down and is cleared by the eye’s natural tears. In approving the product, the FDA reviewed several nonclinical and clinical studies, including a randomized clinical study of 471 adult subjects who underwent cataract surgery and experienced leakage from their incision at the time of operation. Out of the 471 study participants 295 received the ReSure sealant to stop leakage and 176 received a suture. That study showed that ReSure Sealant was more effective than use of a single suture in preventing incision leakage in the first seven days following cataract surgery. Rates of eye pain and sensation of having something in the eye did not differ between the two groups, and there were no significant differences in the occurrence of corneal swelling, inflammation or wound healing. ReSure Sealant is manufactured by Ocular Therapeutix in Bedford, MA. The company will perform a post-approval study evaluating at least 4,857 patients undergoing clear corneal cataract surgery to gather further information on the incidence of adverse events associated with ReSure Sealant.

Related Articles

Congress Urged to Find a Cost-Effective Way to Expand Benefits to Pre-9/11 Veteran Caregivers

WASHINGTON — Veterans from earlier eras should have expanded benefits related to family caregiver, but only if they are severely injured, VA officials have told Congress.

Supplemental Oxygen Needs Rarely Addressed in COPD Inpatients

CHICAGO — Patients hospitalized with chronic obstructive pulmonary disease (COPD) who require supplemental oxygen (O2) are at increased risk of hospital readmissions, but little information exists on the quality of evaluation and documentation regarding the need for supplemental O2 in that population.


U.S. Medicine Recommends


More From 2014 issues

2014 Issues

VA Slammed for Slow Action Against Officials Behind Wait-Time Scandal

Legislators: Only Four Senior Executives Removed by Mid-November

2014 Issues

VA Launches Largest Overhaul Ever as McDonald Pushes Reforms

WASHINGTON - New VA Secretary Robert McDonald continues to methodically tackle the issues that have caused a breakdown in efficient veteran care over the last few years, now pushing the agency to undertake the largest reorganization since its founding.

2014 Issues

VA’s IT Security Controls Cited for 15th Year in a Row

Controversial Scheduling System Will Be Replaced in 2015

2014 Issues

Study Offers New Statistics on How Many OEF/OIF Veterans Have PTSD

BRONX, NY — For patients with chronic kidney disease (CKD), living more than 30 miles from their nephrologist is associated with many unfavorable outcomes. They have lower rates of clinic visit adherence, more limited access... View Article

2014 Issues

Danger of Pneumonia Increases with Veterans’ Worsened Health Status

BRONX, NY — For patients with chronic kidney disease (CKD), living more than 30 miles from their nephrologist is associated with many unfavorable outcomes. They have lower rates of clinic visit adherence, more limited access... View Article

Facebook Comment

Subscribe to U.S. Medicine Print Magazine

U.S. Medicine is mailed free each month to physicians, pharmacists, nurse practitioners, physician assistants and administrators working for Veterans Affairs, Department of Defense and U.S. Public Health Service.

Subscribe Now

Receive Our Email Newsletter

Stay informed about federal medical news, clinical updates and reports on government topics for the federal healthcare professional.

Sign Up