Pharmacy

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.

New Orleans—Travoprost 0.004% (Travatan, Alcon Laboratories) lowers IOP by both increasing outflow facility and improving uveoscleral outflow, according to the results of a clinical study designed to investigate the mechanism of action of travoprost.

New Orleans—Twice-daily administration of a fixed-combination product containing brimonidine 0.2% plus timolol 0.5% (Combigan, Allergan Inc.) safely and effectively lowers IOP, according to the pooled results of two 12-month, randomized, double-masked, phase III studies.

Timolol maleate ophthalmic solution 0.5% (Istalol, ISTA Pharmaceuticals), available in a new, once-a-day formulation, is as effective as a standard 0.5% timolol maleate ophthalmic solution administered twice daily to treat elevated IOP in ocular hypertension and open-angle glaucoma.

New Orleans—Results of a prospective, randomized, double-masked study demonstrate a fixed combination of travoprost 0.004% and timolol 0.5% (Extravan, Alcon Laboratories) administered once daily is safe, well-tolerated, and offers better IOP lowering than monotherapy using either of its components, said Howard S. Barnebey, MD.

Baltimore—Innovative pharmaceutical delivery systems are showing promise for their potential to provide safe and effective "site-directed" therapy for retinal diseases, said Eugene de Juan Jr., MD, in the Ronald G. Michels Memorial Lecture at the Current Concepts of Ophthalmology meeting.

New Orleans—Cytoskeletal agents, which increase outflow facility in the trabecular meshwork, are one of the drug classes that could expand the pharmaceutical options available to reduce IOP, said Carl B. Camras, MD, professor, chairman, and director of the glaucoma service, department of ophthalmology, University of Nebraska Medical Center, Omaha.

Poughkeepsie, NY—DisCoVisc, a new viscous-dispersive ophthalmic viscosurgical device (OVD) from Alcon Laboratories, performed comparably to Healon in a randomized, FDA phase III clinical trial in key measurements such as endothelial cell density and IOP control, according to Satish Modi, MD.

Feds Raid Clinic in Botox Investigation" reported the headline in The Miami Herald (Dec. 2, 2004). "Four victims hospitalized after injection with Botox anti-wrinkle medicine! Details at 11," reported the local news anchor.

On Dec. 17, Eyetech Pharmaceuticals (EYET) announced FDA approval of pegaptanib sodium injection (Macugen) for the treatment of neovascular ("wet") age-related macular degeneration (AMD).

The FDA approved pegaptanib sodium injection (Macugen, Eyetech Pharmaceuticals and Pfizer Ophthalmics) for the treatment of neovascular age-related macular degeneration (AMD) on Dec. 17.

Waltham, MA-OXiGENE Inc. is launching a phase II clinical trial of its lead compound, Combretastatin A4 Prodrug (CA4P), in patients with myopic macular degeneration (MMD) under an investigational new drug application (NDA) submitted to the FDA.

Los Angeles-A clinical trial of a prototype intraocular retinal prosthesis continues to produce encouraging results during ongoing follow-up. Meanwhile, the development program is on schedule for a higher-density device that investigators hope will enable unaided mobility for totally blind individuals, according to Mark S. Humayun, MD, PhD.

Waltham, MA-OXiGENE Inc. is launching a phase II clinical trial of its lead compound, Combretastatin A4 Prodrug (CA4P), in patients with myopic macular degeneration (MMD) under an investigational new drug application (NDA) submitted to the FDA.

Irvine, CA-The FDA has approved Visiogen Inc.'s Investigational Device Exemption (IDE) for the Synchronym dual-optic accommodating IOL.

Albany, OR-Alternative Health & Herbs Remedies is conducting a voluntary recall of all lots of four American Health & Herbs Ministry-brand eye rinse products following an FDA ruling that its manufacturing conditions were insufficient to produce a sterile product.

Durham, NC-Inspire Pharmaceuticals Inc. will exclusively license several patents from the Wisconsin Alumni Research Foundation to develop and commercialize new therapeutics for treating glaucoma.

Sterling, VA-WaveLight's chief executive officer said the company has achieved its greatest accomplishment to date by capturing 20% of all new refractive laser sales in the United States during the last 12 months with its Allegretto Wave.

Santa Barbara, CA-Miravant Medical Technologies has picked Photrex as the brand name for its tin ethyl etiopurpurin (SnET2) drug being developed for photodynamic therapy in the treatment of wet AMD.