Pharmacy

An implantable miniature telescope (IMT, VisionCare Ophthalmic Tech- nologies, Saratoga, CA) may offer improved visual acuity and quality of life in patients with bilateral, endstage age-related macular degeneration (AMD), according to Paul R. Lichter, MD, who made a presentation on behalf of the investigators.

Lexington, SC—International publisher and alternative medicine expert Burton Goldberg, PhD, has joined Biosyntrx's Scientific Advisory Board.

Pittsburgh—Senior executives from some 50 biotechnology, pharmaceutical, and device firms examined the potential for combination drug/device therapies in a weekend conference showcasing the most promising advances.

Irvine, CA—Allergan Inc. has signed an exclusive licensing agreement with Japan's Sanwa Kagaku Kenkyusho Co. Ltd. to develop and commercialize Posurdex for the ophthalmic marketplace in that country.

Irvine, CA—ISTA Pharmaceuticals is asking the FDA for permission to conduct a phase IIb clinical trial for ecabet sodium, a prescription eye drop for treating keratoconjunctivitis sicca (dry eye syndrome).

Albuquerque, NM—The FDA approved a wavefront-guided LASIK procedure (CustomVue, VISX/AMO) for treating mixed astigmatism on March 22.

The FDA approval for marketing of bromfenac ophthalmic solution 0.09% (Xibrom, ISTA Pharmaceuticals) gives the topical medication the distinction of being the first nonsteroidal anti-inflammatory drug (NSAID) in the United States indicated for twice-daily instillation in the management of ocular inflammation after cataract surgery.

Washington, DC &#8212 Alcon Laboratories Inc. introduced the newest addition to its IOL family during a press conference Monday. The AcrySof ReSTOR apodized diffractive IOL recently received FDA approval for cataract surgery in patients with or without presbyopia.

Washington, DC &#8212 With the recent acquisition of VISX and last month's FDA approval of its ReZoom multifocal refractive lens, Advanced Medical Optics (AMO) appears to be experiencing "some exciting times" in ophthalmology.

New York—Laser presbyopia reversal (LAPR) is showing significant promise and patient satisfaction based on 12-month follow-up results from a U.S. phase II clinical trial, said Sandra C. Belmont, MD.

Seattle, WA—Visient Therapeutics Inc. has enrolled its first patient in a new phase I clinical trial to evaluate Light Infusion Technology (Litx) in patients with advanced age-related macular degeneration (AMD). The patient was treated by Gary Edd Fish, MD, at Texas Retina Associates in Dallas.

Toronto—The FDA is allowing OccuLogix Inc. to initiate studies of its RHEO blood filtration system to treat dry age-related macular degeneration after reviewing the Long-term Efficacy in AMD from Rheopheresis in North America (LEARN) protocols.

Plymouth Meeting, PA—Six patients treated with 40 mg of Genaera Corp.'s squalamine lactate (Evizon) had preserved or improved vision in both eyes suffering from wet age-related macular degeneration through a 4-month study, according to the company, which released preliminary results of a phase II clinical trial.

Santa Barbara, CA—Miravant Medical Technologies will conduct phase III clinical trials for rostaporfin (PHOTREX) at 50 investigational sites in central and eastern Europe and the United Kingdom to evaluate a range of patients with wet age-related macular degeneration.

With the push of a button, refractive surgeons now have the capability to align wavefront-guided customized ablations to the correct corneal site. Iris Registration (IR) technology from VISX for use with CustomVue treatment is the first and only FDA-approved, fully automated, non-contact method available to CustomVue surgeons in the United States. The technology is being regarded for its potential to enhance the further efficacy and safety of custom ablations with the VISX system.

Memphis—Switches within rather than between classes of glaucoma medications are less common but appropriate when likely to produce an improvement in efficacy, adverse effects, or compliance, said Peter Andreas Netland, MD, PhD, Siegal Professor of Ophthalmology, University of Tennessee Health Science Center, Memphis.

Indianapolis—The investigational compound ruboxistaurin (Eli Lilly and Co.) may reduce the risk of vision loss associated with diabetic macular edema (DME), according to post hoc analysis of previously reported data. The new analysis also showed that the proximity of DME to the center of the macula was associated with visual acuity and that the severity of central macular involvement was associated with the severity of vision loss, according to Matthew J. Sheetz, MD, PhD, a clinical research physician at Eli Lilly.

Antibiotic resistance is a growing challenge, especially in ophthalmic surgery, and clinicians must remain vigilant and well informed to reduce the risk of infection in their patients, said Michael B. Raizman, MD, a cornea specialist with Ophthalmic Consultants of Boston.

Antibiotic resistance is a growing challenge, especially in ophthalmic surgery, and clinicians must remain vigilant and well informed to reduce the risk of infection in their patients, said Michael B. Raizman, MD, a cornea specialist with Ophthalmic Consultants of Boston.

New Orleans—The modified prolate anterior surface IOL (Tecnis, AMO) is creating a new standard for visual performance after cataract surgery, according to Robert M. Kershner, MD, MS, FACS, at the Spotlight on Cataracts 2004: Cataract Controversies Symposium, held during the joint meeting of the American Academy of Ophthalmology and European Society of Ophthalmology.

Durham, NC—Inspire Pharmaceuticals has announced the results of a phase III clinical study of diquafosol tetrasodium for treatment of dry eye. The 6-week study was a randomized, double-masked comparison of 2% diquafosol ophthalmic solution versus placebo involving 640 patients at 34 clinical sites across the United States.

Kingston, NH—The FDA has approved D.O.R.C. International/Dutch Ophthalmic USA's New Drug Application for its patented VisionBlue staining solution for use in cataract surgery.

Amityville, NY—The FDA has granted approval to Hi-Tech Pharmacal Co.'s Abbreviated New Drug Application for ciprofloxacin ophthalmic solution USP, 0.3%.

Washington, DC—A prominent Republican senator is adding his support to a proposed law that would require pharmaceutical companies and device manufacturers to register trials and post clinical results in a public database.

Dublin, Ireland—An Irish biotechnology company is hoping recombinant microplasmin will simplify vitrectomy in patients with vitreoretinal disorders.

La Jolla, CA—Pfizer Inc. has acquired Angiosyn Inc., a privately held biopharmaceutical company developing an angiostatic agent for ophthalmic diseases, including age-related macular degeneration (AMD).

Actual physician clinic with multiple dispensing locations

Rochester, NY—An enhanced fitting guide approved recently for Bausch & Lomb's orthokeratology treatment (Vision Shaping Treatment) helps to fit patients with a custom lens that eliminates patients' need for daytime eyeglasses, contact lenses, or surgery.

The recently approved fixed combination of loteprednol etabonate 0.5%/tobramycin 0.3% (Zylet, Bausch & Lomb) is the first combination corticosteroid/ anti-infective ophthalmic product to be introduced to the market in more than 15 years.

Boston—Ultra-high-speed spectral domain optical coherence tomography (SD-OCT) is a significant advance in noninvasiveretinal imaging that allows for rapid, comprehensive screening of large areas and three-dimensional (3-D) volume rendering of the optic nerve head and fovea, said Johannes F. de Boer, PhD.