Trifocal lens receives European CE mark

June 24, 2015

Alcon has received European CE mark for a trifocal IOL (AcrySof IQ PanOptix) designed for patients who are undergoing cataract surgery and want to address their near, intermediate, and distance vision needs with one lens.

Alcon Laboratories has received European CE mark for a trifocal IOL (AcrySof IQ PanOptix) designed for patients who are undergoing cataract surgery and want to address their near, intermediate, and distance vision needs with one lens. The implant is indicated for adults with or without preoperative presbyopia.

The lens is an addition to the Novartis subsidiary’s portfolio of presbyopia-correcting IOLs and leverages its AcrySof IQ platform, Franck Leveiller, head of research and development for Alcon’s surgical franchise, said in a statement. That platform includes a toric IOL for patients with cataracts and astigmatism, which is designed to reduce the need for eyeglasses or contact lenses for distance vision; an aspheric lens that aims to improve distance and functional vision; and a multifocal IOL, the ReSTOR lens, which has the goal of reducing the need for glasses or contact lenses in patients with or without presbyopia by improving vision at all distances.

More than 3 million cataract surgeries are performed each year in Europe, according to Market Scope’s 2014 Comprehensive Report on The Global IOL Market. Patients who undergo cataract surgery and do not receive presbyopia-correcting IOLs, however, often need eyeglasses or contact lenses to read.

“Today’s patients undergoing cataract surgery are more likely to seek vision correction options to address various lifestyle tasks such as reading books, using electronic tablets, working on computers and performing outdoor activities without the need for glasses or contact lenses,” Richard Packard, MD, FRCS, FRCOphth, director and senior ophthalmologist at Arnott Eye Associates in London, said in a statement. The new trifocal should provide such patients with a full range of vision and reduce their dependence on glasses, he added.

Alcon recommends that any ophthalmologist considering use of the trifocal lens consult the product labeling for physicians and carefully evaluate patients before surgery. “Some patients may experience visual disturbances and/or difficulty seeing due to the multifocal lens design, especially under dim light conditions,” according to the company. “As with other multifocal IOLs, visual symptoms may be significant enough that the patient will request explantation of an AcrySof IQ PanOptix IOL. Posterior capsule opacification…may significantly affect the vision of patients with multifocal IOLs sooner in its progression than in patients with monofocal IOLs.”

 

Earlier this year, Alcon received U.S. Food and Drug Administration clearance for use of its AcrySof IQ ReSTOR +2.5 D IOL in patients undergoing cataract surgery who are looking to address their near, intermediate and distance vision needs at the same time. The lens, for those with or without presbyopia, already was approved for use in the European Union.

“This technology complements our existing AcrySof IQ ReSTOR +3.0 D IOL in the marketplace, providing more presbyopia-correcting options for ophthalmic surgeons and the patients they serve,” Sabri Markabi, senior vice president of research and development for Alcon, said at the time.