Pharmacy

Washington, DC-The FDA is proposing a set of guidelines geared toward improving the development and availability of new drugs and medical devices.

Minneapolis-Neal A. Sher, MD, FACS, of Eye Care Associates here, is seeking candidates for a research study of an investigational drug for the treatment of dry eye after LASIK.

Washington, DC-The FDA is proposing a set of guidelines geared toward improving the development and availability of new drugs and medical devices.

Richmond, TX-CYNACON/OCuSOFT has merged the operations of EyeCatcher, a Connecticut regional distributor of ophthalmic supplies, into its own ophthalmic pharmaceuticals and supplies operations.

Precautionary measure

Novartis Ophthalmics and Valley Forge Pharmaceuticals Inc. have entered into a licensing agreement for a novel eye medication for myopia, which in phase II clinical trials reduced progression of the disease by 50% in the first 12 months of therapy.

FDA approves faster laser pulse rate

The FDA approval of cyclosporine ophthalmic emulsion 0.05% (Restasis, Allergan) Dec. 26 marked a landmark for ophthalmology. The eye drop therapy for moderate to severe keratoconjunctivitis sicca is unique in that it treats the inflammatory process that causes the condition, and not just its symptoms.

Orlando-CustomCornea wavefront-guided LASIK using the LADARWave aberrometer and the LADARVision4000 excimer laser (Alcon) last October became the first wavefront-guided LASIK system to receive FDA approval for the treatment of myopia. The agency's decision was based on clinical trial data proving that the customized approach delivers superior optical quality compared with conventional LASIK.

Editor's Note: In this month's column,a panel of experts offers tips on when and how to administer intraocular injectionsof corticosteroid for patients with uveitis.

FDA OKs trials of laser reversal of presbyopia

Alameda, CA-InSite Vision Inc. and SIFI (Societa Industria Farmaceutica Italiana), a leading Italian pharmaceutical company, will exclusively manufacture, distribute, and promote the OcuGene genetic glaucoma test in Italy.

Manhasset, NY-In addition to being an effective mast cell stabilizer, pemirolast potassium ophthalmic solution 0.1% (Alamast, Santen) is soothing to the eyes, according to Peter D'Arienzo, MD.

Sunnyvale, CA-Oculex Pharmaceuticals Inc. has completed patient enrollment in its phase II clinical trial of its lead product, Posurdex, for the treatment of persistent macular edema (PME).

Jacksonville, FL-Vistakon has reversed a long-held policy and decided to sell its contact lenses directly to mail-order and Internet seller 1-800 Contacts.

Phase III studies for high myopia, hyperopia show stable refractions, few complications

Los Angeles-Researchers are one step closer to restoring some level of usable vision to certain blind eyes.

Nice, France-The diffractive/refractive, fold-able, multifocal AcrySof IOL (study model MA60D3, Alcon, Fort Worth, TX) achieves similar mean distance vision and better near vision compared with the Array multifocal SA40N IOL (AMO, Santa Ana, CA), an FDA-approved IOL. Importantly, patients reported significantly fewer complaints of halos compared with the SA40N IOL, according to Philippe Dublineau, MD.

Orlando-Cataract and refractive surgeons have worked hard over the last decade, perfecting their surgical techniques. Small-incision cataract surgery has revolutionized the ophthalmic profession as have developments in laser refractive procedures. But surgical technique is only part of the equation for producing outstanding surgical outcomes. Prevention of post-surgical infection is another concern.

Santa Clara, CA-Lumenis Ltd. is hoping to broaden the use of its ophthalmic laser products via two new strategic alliances with Ellex Medical Pty. Ltd. and Moria S.A.

Like other areas of ophthalmology, refractive surgery enjoyed a number of refinements and advancements over the past year, including the FDA approval of both wavefront technology and conductive keratoplasty for hyperopia, and advances in refractive IOLs, among others. However, wavefront technology took center stage as the development cited as having the most potential benefit for patients undergoing refractive procedures. Several refractive surgeons weigh in on advances in their subspecialty in 2002.

In a recent Market Scope report onphakic IOLs, editor David Harmon observes: "Phakic IOLs have become a standard part of the European ophthalmologist's tool kit. CE Mark regulatory approval has been granted to four manufacturers of the devices . . . Europe has become the center of worldwide phakic IOL clinical experience . . . European surgeons implanted an estimated 15,350 phakic IOLs last year."

San Francisco-The angiostatic steroid anecortave acetate continues to show promise as a safe and effective treatment for subfoveal, exudative age-related macular degeneration (AMD), according to results from an interim analysis of an ongoing phase II trial.

Peapack, NJ-Pharmacia Ophthalmology has settled two major multimillion dollar lawsuits with Allergan Inc. and Alcon Inc. 2 months before it is scheduled to merge with pharmaceutical giant Pfizer Inc.

Hunenberg, Switzerland-The FDA has approved Alcon Inc.'s LADARVision System for customized wavefront-guided laser eye surgery in the treatment of myopia.