Medical Device Daily Contributing Writer

KAILUA-KONA Hawaii — The annual Hawaiian Eye Meeting, held this year at the stunning Hilton Waikoloa Resort the past few days, experienced record attendance, as specialists from three critical areas of ophthalmology today — cataract, refractive and retinal surgery — came from all over the U.S. to be educated and relax in the sunny and warm weather.

As the meeting got underway, course participants were greeted with the exciting news that Bausch & Lomb (B&L; Rochester, New York), recently purchased by the private equity firm Warburg Pincus (New York) for $4.5 billion (Medical Device Daily, Oct. 29, 2007), was acquiring privately-owned eyeonics (Aliso Viejo, California).

Although the purchase price was not disclosed, the conference was abuzz with speculation about a premium upfront cash payment and a potentially large earn-out based on future sales performance. With deft leadership from co-founder and CEO Andy Corley, eyeonics has been enjoying tremendous growth. Revenue for the year ended Dec. 31, 2007, of $34 million virtually doubled the prior year’s revenue.

Competing against two of the industry’s giants Alcon (Fort Worth, Texas) and Advanced Medical Optics (AMO; Santa Ana, California), eyeonics has managed to double its share in the premium refractive intraocular lens (IOL) market in the past year, reaching an estimated 30%.

This IOL market sector, which includes Alcon’s ReSTOR and AMO’s ReZoom multi-focal IOL brands, has been growing rapidly in the past few years. And Eyeonics has benefited from the November 2006 launch of its second-generation accommodating IOL, trade-named the Crystalens Five-0, along with a sharp increase in its own sales force and the disenchantment among some surgeons and their patients with the clinical performance of ReSTOR and ReZoom.

The Five-O features a slightly larger diameter optic than its first-generation lens with rectangular plate haptics that allow for greater movement of the lens. It is also easier to implant and more stable within the capsule.

At the American Academy of Ophthalmology (AAO; San Francisco) meeting in New Orleans last November, eyeonics launched its third-generation IOL, called HD-100. It features a proprietary optics design that incorporates a small aspheric surface in the center of the optic.

This appears to increase depth of focus and, more importantly, improve near field reading vision. The design of the HD has thus corrected the major deficiency of eyeonics’ earlier products, which provided excellent intermediate (computer distance) and far vision but were mediocre in the near field.

In a talk titled “Update on the Crystalens Five-0 Accommodating IOL,” Richard Lindstrom, a renowned cataract and refractive surgeon from Minnesota Eye Consultants (Minneapolis) and an adviser to a plethora of ophthalmic companies, noted outstanding clinical results in a recent small HD clinical trial. He reported that about 80% of the HD patients were enjoying superb reading abilities, while retaining excellent intermediate and far vision as well.

Lindstrom also said that HD patients are enjoying vastly improved contrast sensitivitiy. (Contrast sensitivity [CS] measures the ability to see details at low contrast levels and measures two variables: size and contrast.)

On the other hand, visual acuity, which is typically how devices are evaluated, measures only size.

In recent years, the ophthalmic community and the FDA have recognized the importance of CS as a true proxy for the efficacy of an IOL, and all IOL clinical trials incorporate contrast sensitivity as part of the trial requirements.
At an eyeonics-sponsored breakfast at the AAO meeting in November, Jay Pepose, MD, of Pepose Vision Institute (St. Louis), discussed this topic in great detail and said that both monocular and binocular testing revealed higher CS in eyes with Crystalens than either the ReSTOR or ReZoom lenses. Concluding his talk, Lindstrom said, “I have no doubt that the HD provides superior results for my patients.”

Taking a somewhat controversial position, especially considering his role as a consultant to both Alcon and AMO, he asserted, “I am going to switch all my future patients to the accommodating [i.e., eyeonics] IOLs and will not be using the multi-focal lenses anymore.”

Another accommodating IOL is the Tetraflex, manufactured by Lenstec (St. Petersburg, Florida). According to Tetraflex’s principal investigator Paul Dougherty, MD, of the Jules Stein Eye Institute (Los Angeles), who presented here, this lens provides excellent vision and “has become my lens of choice for all my cataract patients.”

Tetraflex is a foldable acrylic lens that is easy to implant and is providing patients with excellent distance vision and enhanced near vision, compared to a standard IOL.

Lenstec recently completed enrollment in its U.S. pivotal trial and will file a PMA application in the first half of 2009 after the FDA’s required one-year follow-up. This lens has the CE mark and is currently being sold in Europe and in several other countries.

Another accommodating lens, not specifically discussed here, is the Synchrony IOL developed by privately-owned, venture capital-backed Visiogen (Irvine, California). The Visiogen device features a unique dual optic lens system with an easy-to-use pre-loaded injector. Synchrony has obtained a CE mark and in fQ07 completed enrollment of its pivotal trial in the U.S. Based on that timeline, the company could be filing a PMA application in late 2008 or early 2009.

Excellent clinical data has been presented on Synchrony at prior ophthalmic surgical meetings, and it appears that this lens will become a significant competitor in the premium IOL space. In another presentation later in the week, Lindstrom spoke on the topic of “Multifocal and Accommodating IOLs: Summary and Thoughts,” saying that he expected accommodating IOLs to “become the preferred option in the future.” He predicted that accommodating IOLs — which accounted for a paltry 1% of all IOL implants in 2007 in the U.S. — will garner a 5% market share by 2010 and 20% by 2020.

The key to this projection is improved technology, which will lead to better ”accommodative amplitude.” The premium IOL segment, which broadly-defined includes multi-focal and accommodation IOLs, as well as toric, aspheric and phakic lenses is boosting the growth of the global IOL market.

The Jan. 9, 2008, issue of “Ophthalmic Market Perspectives,” published by MarketScope (Manchester, Missouri), noted that worldwide premium IOL market unit sales have more than doubled in the past two years, and that in 2007 worldwide premium IOL dollar revenue jumped 28%.

Conversely, the conventional global IOL market, pegged by MarketScope at about $1.6 billion, grew less than 5% last year.