Eyeworld

FEB 2012

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

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February 2012 PRESBYOPIA MPlus is CE marked and widely used across the world but is not ap- proved by the FDA. According to Mr. Plessow, Oculentis has no plans to bring the MPlus to the U.S. "We're trying to go to Canada and South America," said Mr. Plessow. "It's difficult for a small company to get licensed in the U.S. The American medical market is ruled by large companies, so the small ones don't have a chance to get there." PhysIOL's FineVision The FineVision IOL is the first trifo- cal diffractive lens, providing pa- tients with high-quality near, intermediate, and distance vision. It combines two diffractive structures that are adjusted to offer +3.5 D for near vision and another +1.75 D for intermediate vision. Like the MPlus, FineVision reduces the amount of light lost with most diffractive IOLs and uses that light for intermediate vision, while maintaining the per- formance for near and distance. Dr. Daya calls FineVision a "re- ally good lens" and has implanted the IOL in just under 200 eyes. All patients, so far, are spectacle free. "It's a lens where patients go 'wow' the next day," he said. "I thought it would cause night vision troubles because it's a trifocal, but the company was quite clever with how it designed the lens. It's pupil dependent. The center point of the lens has more energy than near." Although Dr. Daya's patients are spectacle independent, Raphaƫl Ervinckx, global marketing manager, PhysIOL, cautions surgeons against overpromising. "We have a high rate of patients that are totally independent of spec- tacles," he said, but surgeons still have to be careful when they consult with patients. "What we suggest [surgeons say is], 'The majority of patients after FineVision don't have glasses.'" Patient selection is important to lens success, said Dr. Daya. For ex- ample, a patient with more than 2 D of astigmatism may need PRK after- ward. "If the astigmatism is with the rule, I can manage it," he said. "If it is against the rule, I worry about [the patients] and tell them they have to have a two-phase operation. I'll do the lens and PRK 6-12 weeks after to treat the residual astigmatism. They will see halos, but those get better with time." A regular, symmetric cornea and pristine tear film and ocular surface are required. Any meibomian gland disease must be addressed first. FineVision was released in Bel- gium last year, and the lens already has 50% of the market share, said Mr. Ervinckx. The lens is CE marked, and PhysIOL hopes to expand the market into other areas soon. "For 2012, we're considering two important markets: the U.S. and Japan," said Mr. Ervinckx. "We are a small company, and we know it's impossible to launch this lens in the U.S. because the FDA requires a lot of money. So in order to do this, our first goal in 2012 is to find a collabo- rator." With the FDA climate affecting the innovation pipeline in the U.S., it's quite possible none of these lenses will ever reach surgeons state- side. "The FDA has raised the bar in terms of what it will accept as proof if a lens really does accommodate," said Dr. Dell. "Instead of just rigor- ous performance criteria, the FDA wants to see rigorous optical data that shows the light is being bent through wavefront analysis, with demonstrations of movement of the lens through imaging technology. It wants to see other evidence besides performance. So in some ways it is asking for data that is very difficult to obtain. "The FDA has the best inten- tions and the interests of our pa- tients at heart," he continued. "It doesn't want to approve something that will hurt someone. But there has to be a balance between being overly cautious and shutting down the pipeline for approvals and pro- tecting the public." EW Editors' note: Dr. Daya is an unpaid consultant for PhysIOL. Drs. Masket and Nichamin have financial interests with PowerVision. Contact information Daya: sdaya@centreforsight.com Dell: steven@dellmd.com Ervinckx: r.ervinckx@physiol.be Masket: avcweb@aol.com Nichamin: georgann@laureleye.com Plessow: enrico.plessow@oculentis.com

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