Pharmacy

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.

Are ophthalmologists and other physicians who have financial relationships with pharmaceutical companies incapable of unbiased work in CME activity? Or, are those who believe any physician-regardless of income sources-can have unfettered, impartial teaching phi-losophies just kidding themselves as to the reality of the medical market place?

New Orleans-The C-01-99 phase III clinical trial of anecortave acetate for depot suspension (Retaane, Alcon Laboratories Inc.) found that the drug did not meet the primary endpoint of non-inferiority to verteporfin (Visudyne, Novartis Ophthalmics and QLT Inc.) in the treatment of neovascular age-related macular degeneration (AMD).

New Orleans-The VEGF (vascular endothelial growth factor) Inhibition Study in Ocular Neovascularization (VISION), a phase III appraisal of three doses of pegaptanib sodium injection (Macugen, Eyetech Pharmaceuticals), found that the 0.3-mg dose of the drug improves visual outcomes in patients with age-related macular degeneration (AMD) compared with a sham procedure and usual care (photodynamic therapy [PDT]).

New Orleans-Two phase III trials, one phase II trial, and one extension trial are under way for anti-VEGF agent, ranibizumab (Lucentis, Genentech). The extension trial indicates that ranibizumab provides a long-term benefit to patients and that it is well tolerated, according to Jeffrey S. Heier, MD, who described the studies during the retina subspecialty day here at the American Academy of Ophthalmology annual meeting.

Irvine, CA-For years, Roger F. Steinert, MD, struggled to carve out time to explore his theories while tending to patients and teaching students in Boston.

Santa Barbara, CA-Miravant Medical Technologies will launch an additional clinical trial in an effort to meet the FDA's conditions for final marketing approval of its tin ethyl etiopurpurin (SnET2).

Plymouth Meeting, PA-Genaera Corp. is expanding its third U.S. phase II clinical trial of squalamine, its small-molecule, anti-angiogenic drug for the treatment of wet age-related macular degeneration (AMD).

An implantable miniature telescope (IMT, VisionCare Ophthalmic Technologies Inc.) may help improve visual acuity in patients with bilateral, end-stage macular degeneration, according to the phase II/III results at 6 months.

Eyeonics announces that it has received FDA approval to market its accommodating IOL (Crystalens) in 0.25-D steps.

Two phase III trials, one phase II trial, and one extension trial of anti-VEGF agent Lucentis (Genentech) are under way.

The C-01-99 phase III clinical trial, which compared a 15-mg dose of anecortave acetate (Alcon Laboratories) with standard administration of verteporfin for the treatment of neovascular age-related macular degeneration (AMD), found that there was no statistical difference between the two treatments.

The VEGF (vascular endothelial growth factor) Inhibition Study in Ocular Neovascularization (VISION), a phase III appraisal of three doses of pegaptanib sodium injection (Macugen, Eyetech Pharmaceuticals) (0.3, 1, and 3 mg) compared with a sham procedure, found that the 0.3-mg dose of Macugen improves visual outcomes in patients with age-related macular degeneration.