FDA Approves First Post-Operative Ocular Sealant
The FDA recently approved ReSure Sealant, a product of Ocular Therapeutix, which can now be commercially sold in the United States to prevent the leakage of postoperative fluids after patients undergo cataract surgery. This is the first sealant the FDA has approved for use in ophthalmic circles.
The ReSure Sealant is composed of 90 percent water and polyethylene glycol hydrogel that is of synthetic origin. The sealants application is fast and can be done in approximately 20 seconds. It is applied immediately after the procedure and retains a blue tint to assist surgeons with the correct placement of the product. The tint later dissipates after a couple of hours. ReSure does not require a post operative visit for removal, as the product sloughs off over time in the tear production process.
According to the company, the sealant was evaluated in a controlled environment using a random multicenter process to conduct the clinical trial. The ReSure Sealant was compared to sutures in clear corneal incisions. The results were suggestive of the ReSure Sealant offering significant improvement in future corneal surgeries, as it prevented targeted leaks 95.9 percent of the time. Sutures, which have been the relied upon method of corneal sealing, only prevented leakage 65.9 percent of the time.
ReSure has been well received in the field as it offers surgeons the ability to provide safer and more effective procedures to their patients, with a lower risk of complications due to leakage. John Hovanesian, M.D., Harvard Eye Associates, was one of the principal investigators associated with the ReSure trial. He issued the following statement in support of the product, “Eye surgeons have been waiting for an alternative to sutures that is easy to apply, comfortable for the patient, and doesn’t require removal following surgery.” He went on to say, “Beyond those advantages, the sealant has shown itself to be even more effective than suture in sealing corneal incisions against the real-world forces that can cause wound leaks after cataract surgery. I foresee this device becoming a staple in ophthalmic practices nationwide.”
The FDA approval is a large leap in the ophthalmology space and for Ocular Therapeutix as well. The company’s president and CEO stated, “Receiving approval to commercialize this product is a huge milestone for the company.”
Source:
http://www.news-medical.net/news/20140110/FDA-approves-Ocular-Therapeutixe28099s-ReSure-Sealant-for-ophthalmic-use.aspx