Bausch & Lomb's planned U.S. re-launch of its PureVision silicone hydrogel contact lens in the second quarter could enable a repeat of the firm's 12% constant currency lens sales growth for 2004.

PureVision "is an extremely important launch for us. We fundamentally believe that the contact lens market, over a period of time, will shift to silicone hydrogel lenses, and we think we have got a terrific silicone hydrogel lens" in PureVision, CEO Ron Zarrella stated in a Jan. 27 earnings call.

U.S. PureVision revenue is critical to the firm's projection of 10%-12% growth in contact lens sales on a constant currency basis in 2005, Zarrella said. Prior to the re-launch, the firm anticipates about 8% lens growth for each of the first two quarters of the year.

The PureVision re-launch will be enabled by the April 27, 2005, expiration of competitor Novartis/Ciba Vision's "Harvey" patent, as well as patent rights gained under a July 2004 cross-licensing agreement with Ciba (¹ Also see "Bausch & Lomb, Ciba Settlement Leaves No Outstanding Suits Between Firms" - Medtech Insight, 12 July, 2004., p. 21).

The silicone hydrogel lenses have been unavailable domestically since February 2003, when a federal appeals court found them to be infringing Ciba's Night & Day lenses and ordered B&L to withdraw them from the market (² Also see "Wesley Jessen Wins PureVision Patent Suit; B&L Weighs Limited Options" - Medtech Insight, 17 February, 2003., p. 11).

Under the licensing pact, B&L agreed to pay Ciba royalties on U.S. PureVision sales until 2014. Overseas, where PureVision has remained available, Rochester, N.Y.-based B&L is required to pay the Novartis unit royalties until 2016.

B&L's contact lens revenue totaled $675.2 mil. in 2004, led by double-digit growth for its SofLens One Day , SofLens 66 Toric , SofLens Multi-Focal and SofLens 59 brands.

While PureVision is approved as a 30-day lens, giving "patients comfort that it is a very healthy product," B&L plans to position it in the faster-growing, two-week replacement lens category, Zarrella explained.

"When PureVision was in the [U.S.] market, it was recognized as the most comfortable contact lens.... The comfort and health benefits are what we think are going to drive" its sales well in excess of the $20 mil. run rate the product attained before it was pulled from the market, the exec added.

Internationally, Zarrella expects B&L's 2005 Japan contact lens revenue growth to benefit once the firm launches versions of its SoftLens59 and SofLens Multifocal, targeted for Q2 and Q3, respectively.

Regarding the Retisert drug-delivery eye implant, the CEO said FDA should respond to B&L's NDA application for treating non-infectious posterior uveitis "next spring." The firm is targeting a commercial launch of the implant in the second half of the year.

If approved for posterior uveitis, a condition B&L estimates to affect 800,000 worldwide, and "depending on the pricing, [Retisert] could be a material improvement to our pharmaceutical business," Zarrella said.

Retisert, which is implanted in the back of a patient's eye, contains a small drug reservoir that delivers the steroid fluocinolone acetonide for a period of up to three years (³ Also see "Next-Generation Retisert R&D Efforts Under Way, Bausch & Lomb Says" - Medtech Insight, 11 October, 2004., p. 38).

Currently, physicians treat posterior uveitis with a variety of adjunctive therapies such as steroid eye drops, periocular steroid injections and systemic corticosteroids and/or immunosuppressive therapy.

Zarrella also addressed B&L's sluggish refractive surgery business, which recorded a 6% decline in constant currency revenue to $43 mil. in Q4 due to lower Zyoptix wavefront ablation system sales.

"In refractive, we are in a period now where we expect laser sales will not be as robust as they have been in the last couple of years....We are in a transition period," he remarked.

However, despite the sales slowdown, the refractive business "increasingly...does fit" in the B&L portfolio, as ophthalmic surgeons operating from ambulatory surgery centers want to be offered a full suite of refractive technologies, Zarrella said.

B&L recorded corporate sales and earnings of $2.23 bil. and $159.6 mil. in 2004, up 11% and 27%, respectively. The firm anticipates 2005 revenue will grow 6%-7% on a constant currency basis.

Bausch &amp; Lomb Predicts Strong Sales From PureVision Re-Launch In U.S.

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Bausch & Lomb Predicts Strong Sales From PureVision Re-Launch In U.S.