Pharmacy

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.

Newark, NJ-Timolol hemihydrate (Betimol, Santen Inc.) is an excellent choice when a beta-blocker is indicated for IOP-lowering in patients with ocular hypertension or glaucoma, said Paul J. Lama, MD.

Houston-In patients with primary open-angle glaucoma (POAG) or ocular hypertension (OH), once-daily treatment with fixed-combination latanoprost/timolol (Xalacom, Pharmacia, Peapack, NJ) is well tolerated and lowers IOP more effectively than twice-daily dorzolamide/timolol (Cosopt, Merck), according to a recent multicenter U.S. study.

Baltimore-Latanoprost 0.005% (Xalatan, Pharmacia) taken once daily is more effective in lowering IOP than unoprostone 0.15% (Rescula, Novartis) taken twice daily, according to a recent multicenter study, reported Henry D. Jampel, MD, MHS.

Fort Worth, TX-The FDA will allow Alcon to add the words "Lasting Comfort" and new rinsing instructions to its Opti-Free Express multi-purpose disinfecting solution label.

A 42-year-old Hispanic male presented complaining of decreased vision in his left eye. He noted that his vision in that eye had decreased suddenly three weeks earlier. The patient had low hyperopia. His medical, surgical, and family histories were unremarkable. He was using no medications and had no known drug allergies. Although he initially reported no significant social history, after more extensive questioning he admitted to the occasional inhalational use of cocaine. His most recent use was on the day prior to the onset of his visual disturbance.

Rockville Centre, NY-Implantation of a posterior chamber phakic refractive lens (PRL) (Medennium phakic refractive lens, CIBA Vision, Duluth, GA) demonstrated positive visual outcomes in the treatment of high hyperopia, according to Alexander Hatsis, MD, who presented the results of the FDA phase II trial.

Napa, CA-When Santen Inc. entered the U.S. marketplace, the company's initial corporate campaign featured a bright-eyed, smiling little girl named Molly. The little girl was the focal point of the campaign that was entitled, "Protecting the Joy of Sight."

Alameda, CA-InSite Vision Inc.'s antibiotic product ISV-401 has proved safe and effective for treating acute bacterial conjunctivitis in a phase II clinical study.

Stanford, CA-The Artisan hyperopia lens (Ophtec BV, Groningen, The Netherlands) appears to provide good visual results for extreme hyperopia ranging from 3 to 12 D, according to phase III results reported by Edward E. Manche, MD, assistant professor of ophthalmology and director of cornea and refractive surgery, Stanford University School of Medicine, Stanford, CA.

Fort Worth, TX-Alcon Research Ltd. is enrolling about 500 patients in a phase III study to compare the effects of anecortave acetate versus verteporfin (Visudyne, Novartis) photodynamic therapy for the treatment of wet age-related macular degeneration.

Monrovia, CA-Twenty-four hours after he became the first patient to receive a Toric Implantable Contact Lens (TICL), Ron Nagel was able to see well enough to pass a driving test without glasses.

Irvine, CA-When Allergan announced in January that it planned to spin off its optical medical device business into a separate company called Advanced Medical Optics (AMO), David E.I. Pyott, chairman, president, and CEO of Allergan, said the company would evolve into a specialty pharmaceutical company.