First Multifocal IOL Gains FDA Clearance
To the cheers of clinical investigators, the FDA last month approved Allergan’s AMO Array multifocal IOL.

The approval came so rapidly, it caught Allergan off guard, says the company’s Nick Tarantino, O.D. For the rest of this year, the lens will only be available to investigators. Surgeons at large will be able to obtain the lens starting next year.

The Array provides distance, intermediate and near vision through a series of concentric rings.  Unlike some other multifocal entries, the center zone is set for distance rather than near.
In a one-year clinical study of 400 Array patients, including both bilateral and monocular cases, 98 percent had 20/40 or better best corrected visual acuity. In a subset of 147 bilateral cases, 98 percent were 20/40 or better and J3 uncorrected. In a different study, 41 percent of 100 patients said they never needed glasses, and an equal number said they wore glasses only occasionally. An ongoing quality of life study finds that Array patients perceive that their general well-being improved after receiving the lens, says Cherry Hill, N.J. surgeon W. Reed Kindermann.

Interestingly, the lens appears to affect contrast sensitivity very little.
Allergan officials say that driving-simulation studies show little difference in loss of contrast sensitivity between binocular multifocal patients and binocular monofocal patients. “In no case was performance worse than the federal limits for driving safety,” says Dr. Tarantino.

Investigators think the Array will be popular. Boston surgeon Roger Steinert says that multifocal IOLs are becoming standard for many European surgeons. “In the beginning, surgeons were cautious, but they realized that the vast majority of patients really appreciated the benefit,” he says. Kansas City’s John Hunkeler, MD, says a patient who has the Array in one eye and a monofocal in the other recently asked him to replace the monofocal lens. “She’s happier with the multifocal eye,” he says.
 

Researchers Close in On ARMD Gene
Medicine may be a step closer to finding the genetic mutation responsible for age related macular degeneration, or ARMD.

In a joint study conducted by the National Institutes of Health, Massachusetts Eye and Ear Infirmary and the University of Utah, researchers studied 167 patients with various stages of ARMD. They were specifically studying a protein called ABCR, found on chromosome 1p21, which is mutated in Stargardt’s disease. Since Stargardt’s also causes drusen build-up and progressive macular atrophy, they reasoned that this gene could play a role in ARMD as well.

So far, researchers have found ARMD-associated alterations in 26 of the patients, or 16 percent of the sample.

Michael Dean, PhD, one of the researchers, says the gene in question codes for a “protein pump which actually pumps substances out of a cell,” he says. “In ARMD, the pump isn’t working and  the substances are accumulating and causing ARMD.”

He says the work “has changed our thinking about ARMD. Though most of the observed damage is in the retinal pigment epithelium, this shows that some may actually begin in the photoreceptor cells.”
The study also showed statistically significant evidence that ARMD could be hereditary. Though only a quarter of the entire sample had a first- or second-degree relative with the condition, fully half of the 26 patients with genetic alterations had such a family connection.
 
 
 

Forty-six percent of the subjects who reported taking Vitamin C 10 years or more had some lens opacities. In comparison, 80 percent of women who took no vitamin C or who took it for only a short period of time had opacities. Seventeen percent of women who took no supplements had moderate opacities, as opposed to 8 percent of those reporting long-term use.

California neuro-opthalmologist August Reader, MD, who has been recommending vitamins for 18 years in his practice, feels the study gives strong evidence that vitamin C’s antioxidant effect is crucial to cataract prevention.

“Everybody over 60 is deficient in at least two-thirds of vitamins they need to resist degenerative problems of aging, and they can’t make it up in their diet.” However, physicians should be aware of the dangers of a “shotgun approach” to vitamin use which focuses on a single vitamin rather than a range of vitamins, minerals, and bioflavinoids, says Dr. Reader.
 
 

Products Move Through Pipeline
Several investigational new products are moving along in the FDA’s approval pipeline. Among them:
 
- Chiron’s Technolas excimer laser. The company submitted a premarket approval application for the laser, containing data on over 1,000 eyes that were treated for as much as 10 D of myopia and 4.5 of astigmatism.

- Staar Surgical’s Glaucoma Wick, a surgical implant for open-angle glaucoma, received approval to start clinical trials. A prepared statement says the wick is made of a proprietary, collagen-based material that eases aqueous outflow. Staar says the device dissolves several months after it’s implanted, leaving behind porous tissue that yields continued fluid drainage over the next several years. Nine clinical centers will enroll 175 patients for the one-year study.

- Sunrise Technology’s Cornea-Sparing Laser thermokeratoplasty (LTK) won approval to move on to Phase III clinical trials. Investigators say Phase II trials show that the procedure produces stable results one and two years after treatment. Sunrise will recruit 200 new patients and at least three new surgeons for the study.

- Keravision, maker of the intrastromal ring, got approval to include myopia as low as –0.5 D and as high as –5 D in its phase III trial. The company’s preliminary results show 97 percent of eyes in the range of –1 D to –3.5 D seeing 20/40 or better.