New York-More drugs are in the pipeline that may have a positive impact on the treatment of patients with age-related macular degeneration (AMD). One that is providing good results is anecortave acetate (15 mg) for depot suspension, (Retaane, Alcon).
New York-Eyetech Pharmaceuticals plans to extend an initial public offering of shares of its common stock.
Del Mar, CA-Eyemakers Inc. has changed its name to EYEM Surgical & Treatment Centers International to reflect the broader nature of its business better.
Irvine, CA -- Two phase III clinical trials of ovine hyaluronidase (Vitrase, ISTA Pharmaceuticals) reveal a statistically significant reduction in vitreous hemorrhage density in patients with diabetes during each of 3 months following a single intravitreous injection of ovine hyaluronidase when compared with a single injection of saline solution.
Indianapolis-The Model 311 Iris Reconstruction Lens (Ophtec) appears safe and has significant benefit for reducing visual disturbances in patients with partial or complete aniridia, according to the first reported results from the FDA phase I trial evaluating that implant.
New York-Treatment is now available for Fabry's disease, a lysosomal storage disorder with ophthalmologic findings. In April, the FDA granted Orphan Drug designation for agalsidase beta (Fabrazyme, Genzyme General), an enzyme replacement therapy, for the treatment of this progressive and potentially fatal disease.
Frankfurt, Germany-Refractive lens exchange with diffractive, bifocal IOL implantation can offer a good option for improving distance vision and restoring near visual acuity in some presbyopic-age patients, said Thomas Kohnen, MD.
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.
.png "Optometry Times"){kind=logo}
