At Press Time

Bending the Phaco Learning Curve

New surgeons are honing skills with the Eyesi simulator.

By Jerry Helzner, Senior Editor

■ If the next generation of US cataract surgeons enter practice with more mastery of the procedure than newly minted surgeons have ever demonstrated before, much of the credit should go the introduction of the Eyesi Ophthalmic Surgical Simulator into residency programs in the last five years.

"Of the 120 ophthalmology residency programs in North America, 48 now own the Eyesi simulator," says Marshall Dial, senior vice president for sales and marketing for VRMagic, of Mannheim, Germany, the only company that offers a commercially available simulator with which to practice ophthalmic procedures. The roster of Eyesi customers includes Wills Eye Hospital, the Mayo Clinic and the Harvard Medical School.

Advocates of using simulation for the training of ophthalmic surgeons, usually as a complement to wet lab, have compared it to the long-accepted use of simulators for pilot flight training. Both pilots and ophthalmic surgeons have to react quickly to a variety of changing conditions that can have a major influence on their decisionmaking. Being able to practice on simulators is intended to build surgeon confidence and outcome predictability.

VRMagic itself is the product of university research. It has its roots in a collaborative virtual reality effort undertaken by medical specialists, physicists and computer scientists at the Universities of Mannheim and Heidelberg. Their first commercial product was the Eyesi Vitreoretinal simulator, which was launched in 2002. Phaco simulation software was added to the platform in 2005. Though a phaco simulator can be purchased as a stand-alone product, Mr. Dial says 80% of residency programs opt for the combination vitreoretinal/ phaco simulator, with prices starting at $150,000.

A visiting resident practicing capsulorhexis on the Eyesi phaco simulator during the highly regarded Harvard cataract course.

"As of today, the phaco simulator is designed to give residents the experience of performing surgery on the average patient, with all the performance dynamics you would see in real life," says Mr. Dial. "There is a novice program for first- and second-year residents and a more advanced program for third-year residents."

Residents using the simulator can create complications by making surgical errors. If they create a complication, they can attempt to rescue the procedure.

Instructors can also intentionally create a complication on the simulator, such as an unstable capsulorhexis, and then ask the resident to try to overcome it. All of the procedures are automatically scored for proficiency in numerous elements of the cataract surgery procedure, with a record kept of each resident's scores.

"There is a great incentive to do well on the simulator because, in some residency programs, proficiency on the simulator can accelerate the transition to doing actual cataract surgery," notes Mr. Dial.

The capabilities of the Eyesi phaco simulator are still being developed.

"The physics-based model is very organic," says Mr. Dial. "We are regularly updating the software and adding new features. We recently improved the capsulorhexis and added a complete I&A simulation. Next, we will be releasing phaco chop and IOL insertion simulations."

Mr. Dial says the goal is to ratchet up the capabilities of the simulator to enable it to eventually deal with such complex issues as capsular tension ring insertion for damaged zonules and floppy iris syndrome.

"We are getting a great deal of feedback from the residency programs that are using the Eyesi," he says. "They are telling us what features they want and are also finding many new ways to use simulation in phaco training.

Additional information on Eyesi ophthalmic simulators, including a new virtual ophthalmoscope product, can be obtained from Marshall Dial at dial@VRMagic.com.

Alimera Sciences Awaits Iluvien Approval

Company sees multiple indications for sustained-delivery insert.

By Andrew E. Mathis, Medical Editor

■ On the heels of its announcement in August that it had received priority review status from the FDA for its Iluvien fluocinolone acetonide extended-release intravitreal insert, Alimera Sciences recently presented 24-month data from its two FAME (Fluocinolone Acetonide for Macular Edema) clinical trials, under which it is testing Iluvien in diabetic macular edema (DME).

Baruch Kuppermann, MD, PhD, of the University of California-Irvine, presented the collective 956-patient FAME data at the 2010 AAO annual meeting, detailing how patients receiving the Iluvien insert continued at the two-year mark to experience statistically significant improvement in visual acuity.

During the FAME study, a statistically significant difference in BCVA was seen at three weeks and this difference was maintained through month 24. A complete 36-month FAME dataset will soon be presented.

Dan Myers, Alimera's president and CEO, told Ophthalmology Management that the FDA has already seen the 24-month FAME data. "We submitted our application for priority review in June," Mr. Myers said, "and they've already been looking at the data for three or four months." Because priority review provides for FDA approval within six months, Alimera expects approval for Iluvien to come by the end of this year.

Since laser photocoagulation is currently the only FDA-approved treatment for DME, if Iluvien receives approval for this indication, it will have a strong, approved entrant in this market, though anti-VEGF therapies and Allergan's sustained-release Ozurdex dexamethasone insert have been used off-label to combat DME.

Moreover, Iluvien may hold promise for macular edema second to retinal vein occlusion (RVO). In this arena, Iluvien would compete with Ozurdex, which is currently the only intravitreal insert to have received FDA approval for any retinal condition.

Beyond approval for DME and RVO, Mr. Myers hopes Iluvien may ultimately be approved to treat both the wet and dry forms of AMD. "We certainly think there's an opportunity for Iluvien to be used in wet and dry AMD," Mr. Myers said. "We're currently conducting phase 2 reviews for these conditions, and we expect some time next year to have the results of those studies. Depending on those results, we'll move forward with phase 3 studies. We're hopeful of positive results."

Of course, with Lucentis having received FDA approval to treat RVO, Genentech may also be a major competitor for Alimera, although Mr. Myers does not discount the possible potential of Iluvien as part of a combination therapy along with anti-VEGF. "I think potential for combi nation therapy is one of the great things about Iluvien," he says. "When you look at the treatment challenges, clearly steroids have a place, and the nice thing about Iluvien is that it would be very complementary."

Another indication of Alimera's progress is that the company this year sold common stock, buttressing its balance sheet with a major infusion of $72 million in new capital to pursue its initiatives. Alimera also received a $32.5 million bank credit facility.

The stock trades on NASDAQ under the symbol ALIM.