at press time

B & L Implant Approved for Uveitis
Retisert Can Deliver Drug for 30 Months.

The FDA has approved Bausch & Lomb's single-indication orphan drug fluocinolone acetonide intravitreal implant (Retisert) for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye.

The Retisert implant is about the size of a grain of rice.

Retisert is the first intravitreal drug implant for the treatment of a condition that affects an estimated 175,000 people in the United States and approximately 800,000 people worldwide. The product received FDA Fast Track status and Orphan Drug designation for this indication. Bausch & Lomb is targeting a mid-year launch of the product.

Bausch & Lomb's patented drug-delivery microtechnology in Retisert consists of a tiny drug reservoir designed to deliver sustained levels of the anti-inflammatory corticosteroid fluocinolone acetonide for approximately 30 months directly to the back of the eye.

"I believe that with its unique drug-delivery technology, Retisert will offer an efficacious treatment for this chronic, severe blinding disease," said Glenn J. Jaffe, M.D., professor of Ophthalmology and director of the Uveitis Service at Duke University Eye Center.

"FDA approval of Retisert represents a significant milestone in Bausch & Lomb's pursuit of new therapies and technologies to treat posterior segment diseases," said Gary M. Phillips, M.D., B & L corporate vice president, Global Pharmaceuticals and Vitreoretinal.

FDA approval of the drug was based on 34-week results from two 3-year, randomized, double-masked, multicenter clinical studies demonstrating that in eyes with Retisert there was:

► a significant decrease in the recurrence of uveitis from approximately 40% to 54% for the 34-week period pre-implantation to approximately 7% to 14% for the 34-week period post-implantation

► a significant decrease in the use of adjunctive therapy, including systemic corticosteroid and/or immunosuppressive therapy, from approximately 47% to 63% at the time of implantation to approximately 5% to 10% at 34 weeks post-implantation, and for patients needing periocular corticosteroid injections from approximately 50% to 65% for the 34-week period pre-implantation to approximately 3% to 6% for the 34-week period post-implantation

► statistically significant improvement of 3 or more lines of visual acuity in approximately 19% to 21% of study eyes at 34 weeks post-implantation.

The most common adverse events attributed to Retisert, which were anticipated given the nature of the disease and the type of drug used, include cataract progression, which is managed by standard cataract surgery; increased intraocular pressure, which is managed with the use of IOP-lowering eye drops or filtering surgery; and procedural complications and eye pain.

Gene Greatly Increases Risk of AMD
Researchers Say it May Account for 50% of Cases.

Researchers from Boston University School of Medicine (BUSM) and the University of Texas Southwestern Medical Center at Dallas (UT Southwestern) report the discovery of a genetic variation that is the strongest known risk factor associated with AMD.

Published in a recent issue of the journal Science, the study, titled "Complement Factor H Polymorphism and Age-Related Macular Degeneration," details the discovery of the gene that may account for approximately 50% of the cases of AMD in the population.

The findings that implicate the complement factor H (CFH) gene in AMD have also been independently corroborated by researchers at the Yale University School of Medicine and at Duke University Medical Center. That gene helps regulate inflammation in a branch of the immune system.

"Considering that AMD is such a common and complex condition with multiple risk factors, we did not expect that we would identify a gene that is responsible for almost half of the cases," said author Lindsay A. Farrer, Ph.D., chief of the genetics program at BUSM.

The biological basis of this disorder is unclear. However, it was strongly suspected that genetics did play a role. The researchers tested single nucleotide polymorphisms (SNPs) for association of AMD in a region of 14 million base pairs on chromosome 1q25-31 where a gene for AMD had been previously localized in families with multiple persons affected with AMD. Using two independent case-control populations, the researchers found that possession of at least one copy of histidine at position 402 of complement factor H increased the risk of AMD almost threefold.

"We hope our findings will create new avenues for developing preventative and therapeutic strategies for AMD," said co-author and retina specialist Albert Edwards, M.D., Ph.D., president of the Institute for Retina Research at the Presbyterian Hospital in Dallas. Dr. Edwards conducted his research while on faculty at UT Southwestern.

Cancer Drug Tried in AMD
Systemic Avastin Produces Positive Results in Small Study.

The University of Miami's Bascom Palmer Eye Institute said early results from the Systemic Avastin for Neovascular Age-Related Macular Degeneration (SANA) study showed that the recently approved antiangiogenic cancer drug bevacizumab (Avastin) was able to substantially reduce the leakage from abnormal blood vessels in eyes of patients with wet AMD. Within 1 week, vision improvement occurred in patients treated with Avastin given through an intravenous infusion.

The SANA results were presented at the recent Macula Society meeting.

The presentation highlighted the outcomes in the first nine patients treated with Avastin through 3 months. Overall, average vision improved in both eyes because most of the patients had wet AMD in both eyes. At the beginning of the study, one eye of each patient was designated as the "study eye" and the other eye as the "fellow eye." At 3 months, the average vision improved just over 2 lines in the "study eyes" (p=0.008) and just over 3 lines in the "fellow eyes" (p=0.001) as measured by the number of letters used on a standard eye chart. The improvement in vision correlated with a decrease in the leakage of fluid from the abnormal blood vessels in these eyes.

"A potential advantage of Avastin over other therapies for wet AMD is that vision improvement can occur within 1 week of treatment," said Philip J. Rosenfeld, M.D., Ph.D., associate professor of ophthalmology at Bascom Palmer Eye Institute and the principal investigator in this clinical trial. "In addition to the improved vision, Avastin causes a reduction in leakage from the abnormal blood vessels, and we observed a restoration of normal macular anatomy."

Avastin, which was developed by Genentech, was approved by the FDA last year for the treatment of colorectal cancer. Ranibizumab (Lucentis), a Genentech/Novartis drug that's closely related to Avastin and given intravitreally, is currently in clinical trials as a treatment for wet AMD.

Dr. Donald M. Gass Dies
He was Voted One of 10 Most Influential Ophthalmologists.

Donald M. Gass, M.D., of Nashville, Tenn., died reently after a long bout with pancreatic cancer. He was 76.

Dr. Gass was selected as one of the 10 most influential ophthalmologists of the 20th century by his peers and inducted into the American Society of Cataract and Refractive Surgery (ASCRS) Hall of Fame in 1999. His work combined his interest in pathology with new techniques for viewing the fundus with the fundus camera and fluorescein angiography.

Dr. Gass was well known for his research on diseases of the retina, macula, and uvea, much of which was done at the University of Miami School of Medicine. In his later years, Dr. Gass continued to practice, and was a professor of ophthalmology at Miami and Vanderbilt University in Nashville.

Dr. Gass is survived by his wife, Margy Ann, and four children, John Donald Gass, Carlton Simpson Gass, M.D., Dean MacIntyre Gass, and Media
Lee Yawn.

"He contributed much to ophthalmology because of his work, his outstanding teaching, and his clinical applications. Many of us have learned a great deal from him and are thankful for it," said ASCRS president, Priscilla Arnold, M.D.

IN THE NEWS

New NSAID. ISTA Pharmaceuticals, Inc. said the FDA has approved the New Drug Application (NDA) for bromfenac ophthalmic solution 0.09% (Xibrom) for the treatment of ocular inflammation following cataract surgery. ISTA expects to launch Xibrom, a topical, twice-daily, nonsteroidal anti-inflammatory solution (NSAID), during the second quarter, after securing commercial quantities of the product from its manufacturer and completing the further expansion of its sales force.

Eric Donnenfeld, M.D., associate professor of ophthalmology, New York University Medical Center, and an investigator in the Xibrom Phase III clinical trials, commented, "Xibrom is the first twice-daily ophthalmic NSAID to be approved in the United States. All other ophthalmic NSAIDS are dosed four times daily. Xibrom represents an advance for ophthalmic care because of the improved patient compliance and its early onset of action."

Vicente Anido, Jr., Ph.D., president and CEO of ISTA, added: "We are excited to receive FDA approval of our third commercial product. With the Xibrom approval, we plan on hiring additional sales representatives in order to reach approximately 10,000 ophthalmologists in the United States."

IOL approved. Advanced Medical Optics, Inc. (AMO) said the FDA has approved the ReZoom multifocal refractive IOL for cataract patients.

AMO says the ReZoom IOL is a new design and next-generation acrylic three-piece multifocal IOL. The ReZoom IOL Balanced View Optics distribute light over five optical zones for enhanced restoration of visual function, providing distance, intermediate and near vision for reduced spectacle dependence. This allows the lens to match its performance characteristics with the lifestyle demands of the patient.

NovaMed CEO dies. Stephen J. Winjum, founder, chairman, president and CEO of NovaMed Inc., which operates a number of ophthalmic surgery centers and also provides other services to ophthalmologists, has died from complications arising from a heart attack he suffered on March 28.

Until a replacement for Mr. Winjum is named, Robert J. Kelly, currently a director of the company, will continue to serve as the presiding director of the board of directors.

QLT CFO resigns. QLT Inc., the developer of Visudyne, said Michael J. Doty stepped down as senior vice president, Finance, and chief financial officer, effective April 15. Cameron Nelson, QLT's vice president, Finance, will serve as acting CFO and assume the duties of the chief financial position for the organization.

Appointed. Santen Inc. has appointed Ted Danse to the newly created position of vice president of Strategic Marketing and Business Development. Danse, a 30-year veteran of the ophthalmic industry, has previously held positions in business and product development with ISTA Pharmaceuticals, Allergan and Bausch & Lomb.

PureVision Toric OK'd. Bausch & Lomb said the FDA has approved the company's PureVisionToric visibility-tinted contact lens for sale in the United States for vision correction in people with astigmatism.

Made from Bausch & Lomb's patented silicone hydrogel material, balafilcon A, the PureVision Toric lens is indicated for the correction of refractive ametropia with astigmatism of up to 5.00D. The PureVision Toric is designed for monthly replacement, and approved for either daily wear or up to 30-day continuous wear.

STAAR sells stock. STAAR Surgical Company, a developer of IOLs and other ophthalmic products, said it has closed the sale of 4.1 million shares of its common stock at $3.50 per share, for gross proceeds of $14.35 million in a private placement to certain institutional investors.

Previously, STAAR had said it was exploring a number of alternatives that would enable the company to continue as a going concern.

Name change. VisiJet Inc. is rebranding the company and will now be doing business as Advanced Refractive Technologies, Inc. (ART). As a developer and marketer of technologies for the ophthalmic surgical market, including the EpiLift System for epi-LASIK, the name change will more closely align the company with its product focus.

REFRACTIVE SURGERY UPDATE

CustomVue approval. VISX, Inc. has received approval from the FDA to market and sell CustomVue treatments for mixed astigmatism. With this CustomVue approval, VISX says it's first in the industry with wavefront-guided treatment for all forms of astigmatism, including myopia with astigmatism, hyperopia with astigmatism and mixed astigmatism.

Douglas Koch, M.D., of Baylor Vision at Baylor College of Medicine and a principal investigator for the VISX mixed astigmatism clinical trial, said, "CustomVue has provided far better quality of vision than the excellent results we were getting with the standard procedure. The continued expansion of labeling for CustomVue allows me to treat more patients with what I believe is the very best procedure on the market today. Mixed astigmatism patients are especially challenging for ophthalmologists because their vision is often difficult to correct with glasses and contacts. The CustomVue treatment may give these patients the opportunity to see better than they could ever see with glasses or contacts."