Medical Device Daily Associate

Alcon (Fort Worth, Texas) reported that the FDA has granted approval of its latest generation of intraocular lenses (IOL) for cataract patients.

The company said that its AcrySof ReStor IOL for cataract patients with and without presbyopia marks a significant technological leap and aims to eliminate patients' need for reading glasses after cataract surgery. Like other IOLs, the ReStor lens is placed inside the eye during surgery, replacing the eye's natural lens.

Importantly, the FDA allowed labeling saying that the new device can "increase the independence from glasses in cataract patients compared to standard monofocal lenses."

This new lens uses what the company termed a "revolutionary" apodized diffractive technology to give patients a full range of quality vision (near, intermediate and distance) that greatly increases their independence from glasses after surgery.

Essentially, this technology allows images at various distances to focus correctly on the retina without requiring the lens to move, as it does in the natural eye.

Doug MacHatton, vice president-investor relations & strategic communications, told Medical Device Daily to think of the lens as a series of concentric rings "which defract the light." He said the apodization "is the transition from one of those rings to another." He added that the combination of the apodization with these refractive rings "creates very high-quality distance vision, plus near vision without the side effects that are associated with some other technologies that employ these types of concentric rings." Some of the problems that he cited with similar products included glare, halo effects and poor night vision.

As examples of other companies that are developing similar technology, but with decidedly mixed results, he cited Advanced Medical Optics (Santa Ana, California), with its Array multifocal IOL, and eyonics (Aliso Viejo, California), with its mechanically accommodating crystalens.

MacHatton said that the approval of the ReStor marks the first time that a company in the industry has been able "to combine apodization with the refractive technology in a lens that is designed to provide excellent vision across the entire vision spectrum, from near to far."

The clinical studies supporting the approval showed that 80% of patients who received the lens did not use glasses for any activities after cataract surgery. The clinical results also showed that 84% of patients who received the lens in both eyes achieved distance visual acuity of 20/25 or better and near visual acuity of 20/32 or better without correction by contacts or glasses while only 23% of the conventional or monofocal control group achieved this level. Near visual acuity of 20/32, or J2, means patients can read the very small stock quotes in the newspaper.

"Approval of the AcrySof ReStor lens is a significant event for Alcon that validates the extensive development work we have done to make it the best lens possible for all of a patient's vision needs. We expect AcrySof ReStor to be a contributor to our growth in the coming years," said Cary Rayment, president and CEO of Alcon, in a statement.

The company, which introduced its previous AcrySof lens in fall 2003, plans to start training surgeons on the new lens next month and to begin U.S. shipments in May.

Alcon's global sales of intraocular lenses represented more than $580 million in 2004, with its family of AcrySof lenses ranking as the most frequently implanted in the world.

Since its introduction in the early 1990s, the AcrySof brand of IOLs has become one of the most frequently implanted lenses in the world, with more than 21 million implants. These foldable acrylic lenses allow for insertion through a smaller incision than necessary to implant silicone lenses

MacHatton said that the new lenses would be priced at a premium ($600 to $900 each) to the standard monofocal lenses ($130 to $150 each).

The company said that clinical investigators and other surgeons will make several presentations on the ReStor lens in conjunction with the annual meeting of the American Society of Cataract and Refractive Surgeons (Fairfax, Virginia) in Washington in April.