Pharmacy

New York-Pfizer Inc. is looking to boost shareholder earningsby studying options-including a sale or spin-off-forits over-the-counter (OTC) drug unit, which includes the Visineline of eye drops.

Exton, PA-Othera Pharmaceuticals Inc. has announced theinitiation of a phase II clinical trial by the National EyeInstitute (NEI) of Othera's topical eye drop OT-551 in patientswith geographic atrophy (GA). The NEI will investigate OT-551'spotential to slow enlargement of the atrophic area in the maculaand prevent progression to the vision-threatening advanced stagesof age-related macular degeneration (AMD).

Irvine, CA-The Committee for Medicinal Products for Human Use(CHMP) has recommended that the European Commission approveGanfort, Allergan's bimatoprost (Lumigan)/timolol ophthalmicsolution combination product for glaucoma. The CHMP opinion servesas the basis for a European Commission approval, which is expectedto be finalized in the second quarter of 2006.

Atlanta-Alimera Sciences Inc. and pSivida Limited haveannounced that following a planned interim review, an independentData Safety Monitoring Board (DSMB) has recommended thecontinuation of their phase III clinical trial of Medidur.

The study of proteomics could identify candidate proteins thatmight be targets for pharmaceutical therapies for age-relatedmacular degeneration (AMD), said Deborah A. Ferrington, PhD,assistant professor in the departments of ophthalmology andbiochemistry, molecular biology and biophysics at the University ofMinnesota, Minneapolis.

Native Americans used their experience and were able to care for themselves very well.

New York?The Scleral Spacing Procedure (SSP) for Presbyopia with PresVIEW Scleral Implants (PSI) (Refocus Group Inc., formerly PresbyCorp) provides significant improvement in near visual acuity (VA) and no change in the uncorrected distance VA, according to Barrie D. Soloway, MD, FACS.

Boston?Ruboxistaurin mesylate (Arxxant, Eli Lilly), an investigational drug that is an oral protein kinase C (PKC) beta inhibitor, reduced the occurrence of sustained moderate vision loss by 40% in patients with moderately severe to very severe nonproliferative diabetic retinopathy, reported Lloyd P. Aiello, MD, PhD.

Boston?The 12-month results of two randomized clinical trials of ranibizumab (Lucentis, Genentech) indicate that the drug shows encouraging signs of activity against vascular endothelial growth factor (VEGF) in age-related macular degeneration (AMD).

Winter Haven, FL?A number of new pharmacologic options for exudative age-related macular degeneration (AMD), mostly designed to block different steps in the angiogenic cascade, are in various stages of development and testing, and some may one day be shown to improve outcomes, said Michael J. Tolentino, MD, director of clinical research, Center for Retina and Macular Disease, Winter Haven, FL.

Mentor, OH?To meet the needs of a growing global customer base, Volk Optical has appointed Tim Warrell to the newly created position of marketing and customer service manager.

During resident clinic recently, I met an elderly woman suffering from age-related macular degeneration (AMD). Upset with 20/300 vision in her left eye, she was desperate to maintain her right eye's 20/25 vision.

An investigational ophthalmic combination product containing tobramycin 0.3% and prednisolone acetate 1% seems to be bioequivalent to a marketed preparation of prednisolone acetate 1%, according to recently released results from a phase III trial.

During resident clinic recently, I met an elderly woman suffering from age-related macular degeneration (AMD). Upset with 20/300 vision in her left eye, she was desperate to maintain her right eye's 20/25 vision.

South San Francisco, CA?Genentech Inc.'s ranibizumab (Lucentis), a much-anticipated potential treatment for wet age-related macular degeneration (AMD), has received priority review status from the FDA as part of its Biologics License Application filing.

Fort Worth, TX?The European Medicines Agency's Committee for Medicinal Products for Human Use has reacted positively to the initial marketing authorization for Alcon Laboratories' travoprost 0.004%/ timolol 0.5% solution (DuoTrav) for lowering IOP.

Madison, WI?Investigators expanded the eligibility criteria of the SCORE study, a multicenter, randomized clinical trial designed to investigate the safety and efficacy of standard care versus intravitreal triamcinolone acetonide (IVTA) injections for the treatment of macular edema associated with central and branch retinal vein occlusion. The broader standards will accommodate a patient population more closely matched to those seen in the practice setting.

Madison, WI?Investigators expanded the eligibility criteria of the SCORE study, a multicenter, randomized clinical trial designed to investigate the safety and efficacy of standard care versus intravitreal triamcinolone acetonide (IVTA) injections for the treatment of macular edema associated with central and branch retinal vein occlusion. The broader standards will accommodate a patient population more closely matched to those seen in the practice setting.

Carlsbad, CA?SynergEyes Inc. has launched its interactive Web site at www.synergeyes.com. The site offers the ophthalmic industry and the general public the opportunity to obtain product information for the hybrid contact lenses produced by the company. SynergEyes lenses feature a rigid, gas-permeable center and a soft, hydrophilic outer skirt, resulting in a durable hybrid lens for patients seeking crisp, clear vision with the comfort of a soft lens.

FDA approval of the crystalens (eyeonics), in addition to the AcrySof ReSTOR (Alcon Laboratories) and ReZoom multifocal (AMO) IOLs, allows ophthalmologists the ability to offer various choices of presbyopia-correcting technology with the hope of providing a surgical procedure that will greatly reduce or eliminate their patients' dependence on glasses following cataract surgery and refractive lens exchange. Hype and rumor regarding accommodating lens technology has created confusion regarding just how effective or ineffective these particular lenses may be. A review of the results in peer-reviewed medical literature in addition to an analysis of theoretical considerations with regard to the limits of accommodation provided by these lenses should clarify their ultimate usefulness in the average ophthalmic practice.

Chicago?Evidence of a rising incidence of acute endophthalmitis postcataract surgery has intensified attention regarding the role of antibiotic prophylaxis, but the jury is still out on the efficacy of topical and intracameral therapy for reducing the risk of this sight-threatening infection, said Robert W. Snyder, MD, PhD, at the American Academy of Ophthalmology annual meeting.

While pharmaceutical companies increasingly target consumers, doctors remain the focal point.

Chicago—The pegaptanib sodium (Macugen, OSI/Eyetech Pharmaceuticals) exploratory phase II data indicate that the drug seems to be successful for treating diabetic macular edema (DME), according to Steven D. Schwartz, MD. He reported the findings of the Macugen Diabetic Retinopathy Study Group during the retina subspecialty day at the American Academy of Ophthalmology annual meeting.

Lisbon, Portugal—Accurate adjustment of the new Light Adjustable Intraocular Lens (LAL) (Calhoun Vision) after implantation is possible using new digital light delivery systems and may eliminate the need for explantation of the IOL because of incorrect lens power after cataract surgery, reported Nick Mamalis, MD, at the annual meeting of the European Society of Cataract and Refractive Surgeons.

The recently reported success with vascular endothelial growth factor (VEGF) inhibitors in patients with age-related macular degeneration (AMD) provides an important new therapeutic modality for wet AMD and an exciting victory for biotechnology. Yet, the best results will eventually come from interventions that target earlier steps in AMD pathogenesis.