FDA Clears Bausch + Lomb’s enVista™ “Glistening Free” Intraocular Lens

In short

Global eye health company Bausch + Lomb has announced FDA clearance for its  enVista™ hydrophobic acrylic intraocular lens (IOL). In a press release the company claims its new lens represents a significant step forward in IOL technology, as it is the first and only FDA-approved IOL in the U.S. with labeling that states: “No glistenings of any grade were reported for any subject at any visit in the clinical study”.(1-2)

Background

Glistenings are fluid-filled microvacuoles that can form within an IOL and are common in some hydrophobic acrylic IOLs. Literature reports indicate that glistenings may not only present an aesthetic issue post-surgery for surgeons, but they can impact visual function, including visual acuity and contrast sensitivity in patients, due to a portion of light coming into the eye being scattered.(3-4)

Also setting enVista apart from currently available IOLs is what the company states is its unique combination of aspheric, aberration-free Advanced Optics (AO) technology.(5)

Additionally, the enVista lens is designed to minimise Posterior Capsular Opacification (PCO), a common post-surgical complication with IOLs that cause vision to become clouded post-surgery.

All in all, Bausch + Lomb is sounding pretty pleased with itself, claiming that the new lens’s combination of features provide surgeons with the opportunity to optimise short-and long-term outcomes for their patients.(6-7)

Clinician comments

“Based on my experience, the new enVista hydrophobic acrylic IOL is an exciting addition to our IOL choices, as it has been clinically-proven to be free of glistenings, a common issue observed in some other hydrophobic IOLs,” said Louis D. “Skip” Nichamin, M.D., medical director of the Laurel Eye Clinic and the Laurel Laser & Surgery Center and one of the principal investigators in the FDA IDE trial for enVista.

Company comments

“The enVista IOL is yet another example of how Bausch + Lomb is advancing eye health innovation to meet the needs of our customers and the patients they serve,” said Cal Roberts, M.D., executive vice president and chief medical officer, Bausch + Lomb. “We’ve listened to our customers tell us how frustrating glistenings can be when conducting post-surgical examinations of their patients. We are proud to offer them an attractive, viable and technologically-advanced option to address this concern.”

“As our first entry into the hydrophobic acrylic market, which makes up a significant segment of the overall IOL market in the U.S., the approval of enVista represents a key milestone for Bausch + Lomb’s Surgical business,” said John Barr, executive vice president and global president, Bausch + Lomb Surgical. “We’re happy to be the only company with the distinction of offering an IOL proven to be glistening-free.”

Regulatory status

The enVista lens received CE Mark approval in September 2011. Full commercial release in the U.S. is planned upon FDA clearance of its supporting insertion system.

Source: Bausch + Lomb

References

1. Bausch & Lomb, Inc. Data on file, 2009.

2. Tetz. ASCRS. 2009.

3. Christiansen G, et al. Glistenings in the AcrySof intraocular lens: pilot study. J Cataract Refract Surg. 2001; 27:728-33.

4. Dhaliwal et. al. Visual significance of glistenings seen in the Acrysof Intraocular lens. J Cataract Refractive Surg. 1996; 22(14): 452-457.

5. Pepose JS, Qazi MA, Edwards KH, Sanderson JP, Sarver EJ. Comparison of contrast sensitivity, depth of field and ocular wavefront aberrations in eyes with an IOL with zero versus positive spherical aberration. Graefes Arch Clin Exp Ophthalmol. 2009; 247(7):965-973.

6. Johansson B, Sundelin S, Wikberg-Matsson A, Unsbo P, Behndig A. Visual and optical performance of the Akreos® Adapt Advanced Optics and Tecnis Z9000 intraocular lenses: Swedish multicenter study. J Cataract Refract Surg. 2007; 33(9):1565-1572.

7. Nishi O, Nishi K, Osakabe Y. Effect of intraocular lenses on preventing posterior capsule opacification: design versus material. J Cataract Refract Surg. 2004; 30(10):2170-2176.