at press time

Study: AMD Drug Helps 95% of Patients
Lucentis Shows Impressive Results in Phase III Trial.

Genentech, Inc. announced that the Phase III MARINA clinical study of the investigational drug Lucentis met its primary efficacy endpoint of maintaining vision in patients with wet AMD. In a preliminary report on study results, the company said that approximately 95% of patients maintained or improved vision (defined as a loss of less than 15 letters in visual acuity) at 1 year when treated with Lucentis injections, compared to approximately 62% of those in a control group given a sham injection.

Patients treated with Lucentis for 12 months had, on average, a significant improvement in visual acuity compared to their visual acuity at study entry, an important secondary endpoint, while the control group demonstrated a substantial decrease in mean visual acuity from baseline to 12 months.

The Lucentis data were by far the most impressive to come from any Phase III study of a therapy for wet AMD. The stock of Eyetech Pharmaceuticals, the developer of the already-approved wet AMD drug Macugen, dropped about 45% to $12.95 a share on May 24, the day after the Lucentis results were announced. In Phase III trials, Macugen was able to improve visual acuity in only a small percentage of patients. However, a statement by Eyetech noted that data on ongoing Lucentis trials are incomplete and that the patient populations in the clinical studies for the two drugs may not be comparable.

"These Lucentis data exceeded our expectations because they show, for the first time in a Phase III trial, a statistically significant improvement in vision for patients in a disease that has remained chronic and progressive despite current treatment options," said Hal Barron, M.D., Genentech senior vice president development, and chief medical officer.

Genentech said a preliminary analysis of the data showed that adverse events were similar to those seen in earlier trials of Lucentis. Common side effects occurring in the Lucentis arms more frequently than in the control group were mild to moderate and included conjunctival hemorrhage, eye pain and vitreous floaters. Serious ocular adverse events occurring more frequently in Lucentis-treated patients were rare (<1%) and included uveitis and endophthalmitis. There appeared to be no imbalance in serious nonocular adverse events.

In another Lucentis clinical trial, Genentech said that the Phase I/II FOCUS study of the drug met its primary efficacy endpoint of maintaining vision in patients with wet AMD when used in combination with Visudyne photodynamic therapy (PDT). Genentech said that approximately 90% of patients maintained or improved vision when treated with the combination of Lucentis and PDT, compared to approximately 68% of those treated in the control arm of PDT alone. Patients treated with Lucentis plus PDT at 12 months had, on average, a significant improvement in visual acuity compared to visual acuity at study entry, an important secondary endpoint, while the PDT-alone group demonstrated a decrease in mean visual acuity from baseline to 12 months.

AMO Completes Purchase of VISX
Company Now Expects $1 Billion in Sales in 2006.

Advanced Medical Optics (AMO) has completed its acquisition of VISX, Inc., the leader in the development and manufacture of excimer lasers used in laser vision correction procedures. The $1.2 billion purchase was accomplished by offering VISX stockholders a combination of AMO shares and cash worth about $25 a share.

The acquisition of VISX follows AMO's $450 milion purchase of Pfizer's ophthalmic surgical business last year and is expected to enable AMO to achieve total sales of more than $1 billion next year.

Jim Mazzo to head a $1 billion company.

"We view refractive surgery as an extremely important growth opportunity in ophthalmic devices," said AMO president and CEO Jim Mazzo. "The acquisition of VISX transforms AMO into the world's leading refractive surgical company and demonstrates our commitment to this fast-growing market."

In a recent interview with Ophthalmology Management, Russ Trenary, AMO corporate vice president and chief marketing officer, said AMO's goal is to make the transition period seamless to customers.

"We will maintain both the AMO and VISX sales forces so that doctors will be able to continue their professional relationships with the sales and marketing specialists whom they know and trust," said Trenary. He said cost reductions will be achieved by eliminating duplicate positions in administrative areas such as human resources, finance and information technology and other corporate staff.

He said that AMO plans to transfer the marketing of its Amadeus microkeratome to the VISX sales force because "it's a logical fit." Trenary also said that production of AMO phaco machines would eventually be shifted to a VISX manufacturing facility in Santa Clara, Calif.

Though AMO now has about $600 million in debt, Trenary said the company remains in a financial position to continue to make new investments in the business.

AMO has also adopted the VISX stock symbol "EYE" to represent AMO shares on the New York Stock Exchange.

"Our old symbol was AVO, which really didn't mean much," Trenary noted. "The symbol EYE represents the focus of what we do."

Liz Davila, former chairman and CEO of VISX, has joined the AMO board of directors, while former VISX President and COO Doug Post joins AMO as president of its Americas region.

IN THE NEWS

Retaane is "approvable." Alcon, Inc. said that the FDA has issued an approvable letter for its New Drug Application (NDA) for Retaane 15 mg (anecortave acetate suspension), an investigational treatment for preserving the vision of patients with wet AMD.

Industry analysts said final approval will almost certainly require another clinical study.

Alcon said it will meet with the FDA to discuss the approvable letter, the clinical studies submitted with the NDA and other ongoing clinical studies for Retaane to determine the steps necessary to gain final approval for the wet AMD indication.

Retaane is administered with a blunt-tipped, curved cannula to deliver the drug behind the eye without puncturing the eyeball. The drug is administered once every 6 months. No clinically relevant side effects related to the medication or application procedure were reported in the study.

Alcon has conducted extensive clinical research into Retaane over the last 5 years. The company has reported results from two pivotal studies that formed the basis of its clinical package for its NDA.

The first study demonstrated that after 1 year, 79% of patients treated with Retaane maintained their vision, compared to 53% of those who received a sham application. The second study demonstrated that after 1 year, the visual outcomes in patients who received Retaane were not statistically different from those of patients who received photodynamic therapy.

B&L to Build Research Center
Company Will Increase its Investment in R&D

Bausch & Lomb has announced a major expansion that will nearly double the company's main research and development center in Rochester, N.Y. The $35 million project includes $25 million for new construction and $10 million for renovations, equipment and machinery.

	The research center is expected to be completed by 2007.

The two-story 75,000-square-foot glass-and-brick wing will house laboratories and offices, and allow room for a future 25,000-square-foot addition. The company is adding up to 200 research jobs over the next 2 years as it continues to increase its investment in new product research and development.

B&L CEO Ron Zarrella told Ophthalmology Management last year that one of his major priorities was to put a greater percentage of the company's revenues into spending for R&D. Recently, B&L has been earmarking about 7% of overall revenues for R&D while Alcon devotes about 10% of its total sales to its research and development effort. Zarrella's goal is to close that gap.

"One of the deciding factors to expand our worldwide R&D center here in Rochester was the outstanding assistance from New York State, Rochester Gas & Electric, the City of Rochester, Monroe County and facilitated by Greater Rochester Enterprise," said Zarrella. "We thank them for their commitment to working together to improve the economic vitality of this region, and to making this an attractive location to grow our business and add jobs."

Rochester City Council has voted to include a 22-acre portion of the research center campus in the City of Rochester Empire Zone, an action that, when approved by Empire State Development, will allow Bausch & Lomb to apply for various tax incentives through the Empire Zone. Groundbreaking on the research center is slated for this summer. Construction is scheduled for completion in early 2007. The company also is eligible to receive a capital grant from Empire State Development.

IN THE NEWS

Acuity in partnership. Acuity Pharmaceuticals, a product-focused ophthalmic pharmaceutical company, said it has entered into a strategic collaboration with Intradigm Corporation, a pioneer in the field of RNA interference (RNAi), that gives Acuity exclusive rights to Intradigm's leading technology for topical and systemic drug delivery for ophthalmic uses. Acuity and Intradigm also will collaborate to develop a topical, and potentially other formulations, of Acuity's lead compound, Cand5. In addition, the agreement exclusively licenses rights to Intradigm's siRNA ophthalmic drug discovery platform and portfolio to Acuity, as well as the intellectual property associated with the ophthalmic drug discovery and delivery programs.

Acuity's lead compound Cand5 was the first RNAi therapy to enter human studies, and the company intends to initiate Phase II trials of Cand5 in wet AMD later this year. Cand5, like other drugs in development for these conditions, is currently administered by intravitreal injection. Acuity says the availability of alternative delivery modes, including topical or systemic formulations, will likely significantly increase the already sizeable population expected to seek treatment for AMD in the coming years. They also will make development of prophylactic and early treatment options more feasible.

OOSS elects officers. The Outpatient Ophthalmic Surgery Society (OOSS) has announced its new officers for the 2005-2006 period. William J. Fishkind, M.D., of Tucson, Ariz. is the new president. Other officers include Paul S. Koch, M.D. of Warwick, R.I., vice president, and Paul N. Arnold, M.D., of Springfield, Mo., secretary-treasurer.

The OOSS is a professional organization that is the primary source of information for ophthalmic ASC leadership and advocacy.