Pharmacy

San Francisco-A federal judge will decide this fall whether a generic formulation of ketorolac tromethamine violates a patent held by Syntex Pharmaceuticals and licensed to Allergan Inc. to make Acular.

Irvine, CA-ISTA Pharmaceuticals is seeking FDA approval to use hyaluronidase (Vitrase) as a spreading agent to facilitate the dispersion and absorption of other drugs.

Stanford, CA-The phase III trial of the iris-claw phakic IOL (Artisan, Ophtec) for the treatment of hyperopia is now 2 years post- launch, and the short- and long-term results from the interim analyses are very encouraging, said Edward E. Manche, MD.

Editor's Note: The CrystaLens was recommended for approval by the FDA's Ophthalmic Devices Advisory Panel in late May. The lens may be commercially available later this year or early 2004. Dr. Doane's presentation was given at the annual meeting of the American Society of Cataract and Refractive Surgery prior to the recommendation.

Irvine, CA-The FDA has issued ISTA Pharmaceuticals Inc. an approvable letter for Istalol (timolol), a once-daily liquid formulation for the treatment of glaucoma.

San Francisco-An investigational oval suction ring for the Carriazo-Pendular microkeratome (Schwind) allows for optimal suction even in astigmatic eyes and maximizes the ablatable area of the stromal bed, according to its inventor.

Fort Worth, TX-With the recent FDA approval of its foldable, ultraviolet (UV)-, and blue-light-filtering IOL, Alcon believes its AcrySof Natural single-piece lens has the potential to set a new standard in IOLs.

Washington, DC-Drug companies will be limited to one 30-month stay of a generic drug's entry into the market under new FDA rules introduced by the federal Health and Human Services department.

Durham, NC-Inspire Pharmaceuticals Inc. is asking the FDA for approval to market diquafosol tetrasodium (INS365) eye drops in a 2% preservative-free solution for the treatment of dry eye.

Fort Lauderdale, FL-Gatifloxacin ophthalmic solution 0.3% (Zymar, Allergan) shows clearly improved activity against commonly encountered gram-positive ocular bacteria in vitro compared with older fluoroquinolones. This fourth-generation fluoroquinolone received FDA approval in March (see related article, Ophthalmology Times, May 1 issue, Page 1).

Fort Lauderdale, FL-In eyes with predominantly classic subfoveal choroidal neovascularization (CNV) treated with photo- dynamic therapy (PDT) using verteporfin (Visudyne, Novartis Ophthalmics), vision remained stable and the need for additional treatment decreased dramatically over time, reported Peter K. Kaiser, MD, at the annual meeting of the Association for Research in Vision and Ophthalmology.

Fort Lauderdale, FL-A 4-day course of moxifloxacin ophthalmic solution 0.5% (Vigamox, Alcon) is a safe and effective treatment for bacterial conjunctivitis in adults and children as young as 1 month old, according to results from a phase III FDA study, reported Harold R. Katz, MD, who spoke on behalf of the Moxifloxacin Conjunctivitis Study Group at the annual meeting of the Association for Research in Vision and Ophthalmology. The fourth-generation fluoroquinolone received FDA approval in April for the treatment of bacterial conjunctivitis (see related article, Ophthalmology Times, June 1, 2003 issue, Page 1).

Fort Lauderdale, FL-In a phase I, multicenter, randomized trial, the anti-VEGF antibody fragment rhuFab V2 was shown to be safe and well-tolerated in eyes with neovascular age-related macular degeneration (AMD), according to Philip J. Rosenfeld, MD, PhD.

Pittsburgh-When the FDA recently approved ketorolac tromethamine ophthalmic solution (Acular LS 0.4%, Allergan), history was made on several fronts. Not only was it a banner day for Allergan, whose solution won approval, but it represented the first time an electronic patient diary was used to collect and tabulate primary efficacy data for a phase III pivotal trial.

San Francisco-Pediatric LASIK is an investigational procedure, but it can be a feasible and safe modality for young patients with anisometropic amblyopia who truly have no other option for improving best-corrected vision, said Jonathan M. Davidorf, MD, at the annual meeting of the American Society of Cataract and Refractive Surgery.

Rochester, NY-Now that Bausch &Lomb has won its battle to release its generic version of brimonidine tartrate ophthalmic solution 0.2% (Alphagan, Allergan), the ophthalmic industry is waiting to see whether physicians will choose the generic version of the old standard or brimonidine tartrate 0.15% (Alphagan P, Allergan).

Pinellas Park, FL-A 34-member team from Transitions Optical Solutions is working with eye-care practices across the United States and Canada to promote the company's business-building strategies, product information, and training resources.

Aliso Viejo, CA-The FDA's Ophthalmic Devices Advisory Panel is recommending approval of the first accommodating IOL in the United States.

San Francisco-The AcrySof Natural IOL (Model SB30AL, Alcon), containing a covalently bonded, blue light-filtering chromophore (ImprUV), more closely mimics the light transmission spectrum of the precataractous adult human crystalline lens compared with standard UV-absorbing IOLs without any adverse effects on vision, said Paul H. Ernest, MD, at the American Society of Cata-ract and Refractive Surgery an-nual meeting.

Baltimore-Morton Goldberg, MD, will enter a new phase of his career this month when he will step down as director of the Wilmer Eye Institute, Johns Hopkins University School of Medicine. Effective July 1, Peter J. McDonnell III, MD, chairman of the ophthalmology department at the University of California-Irvine, will take the helm as the institute's new director (See Page 10).

Santa Clara, CA-VISX Inc. is celebrating the FDA approval of its CustomVue laser-vision correction procedure, as its board survived an attempt to dethrone one member in a takeover plan by financier Carl C. Icahn.

Napa, CA-Santen Pharmaceutical Co. is hoping that its higher-concentration ocular antibiotic will set a new standard for treatment of bacterial corneal ulcers.

ISTA Pharmaceuticals Inc. has filed an investigational new drug application with the FDA to begin a phase III study of bromfenac.

The first one-bottle daily lens-care system for rigid gas permeable (RGP) contact lenses will be available this month from Bausch & Lomb. The FDA approved Boston Simplus Multi-Action Solution in May.

Fort Lauderdale, FL-Novartis Ophthalmics and QLT Inc. have received the 2003 Helen Keller Prize for Innovation in Eye Care for their development of verteporfin for injection (Visudyne) therapy.

Alameda, CA-InSite Vision Inc. has initiated a phase I clinical study with ISV-403, a treatment for ocular bacterial infections.

San Diego-ACADIA Pharmaceuticals will collaborate with Allergan Inc. to develop eye-care applications related to chemistries that ACADIA has identified for a wide range of G-protein coupled receptor and nuclear receptor targets.

When prescribing ophthalmic drugs, the decision of whether to opt for a generic substitute involves greater consideration than may be required for a systemic agent.

Saratoga, CA-A pivotal trial has begun with the implantable miniature telescope (IMT) (VisionCare Ophthalmic Technologies Inc., Saratoga, CA), a low vision IOL for patients with age-related macular degeneration (AMD), following a successful phase I trial. In that trial, most patients gained three or more lines of near or distance visual acuity and improved their ability to perform daily activities.

The FDA has approved the expansion of the clinical trial of Anamed Inc.'s Perma-Vision intracorneal lens for the correction of hyperopia up to +6 D.