Pharmacy

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.

Bethesda, MD—Paris-based Neurotech is initiating a phase II human clinical trial here of its encapsulated cell technology (ECT) for the treatment of vision loss due to the dry form of age-related macular degeneration (AMD).

Favorable Phase I study results have led to the launch of a Phase I/II trial evaluating the efficacy and safety of AdPEDF (GenVec) treatment of exudative AMD, said Timothy Stout, MD, at the World Ophthalmology Congress.

Interim results from a Phase I study suggest that intravitreal injection of VEGF Trap (Regeneron Pharmaceuticals) is a promising new approach for the treatment of exudative age-related macular degeneration, said Quan Dong Nguyen, MD, at the World Ophthalmology Congress.

Evidence-based medicine has provided some guidance on the management of herpes simplex virus (HSV) keratitis, but there are still many questions left unanswered, said Thomas J. Liesegang, MD, at the World Congress of Ophthalmology.

Dunfermline, Scotland—Optos plc has been selected as one of 36 technology pioneers for 2006 by the World Economic Forum.

Irvine, CA—Allergan Inc. celebrated the opening of its new $60 million Herbert Research Center here in December. Touted as a state-of-the-art facility to study eye disease and neurologic disorders, the center will house areas for molecular biology, neuromodulator research, high-throughput screening, and medicinal chemistry.

Rochester, NY—Bausch & Lomb will work with two biopharmaceutical companies on the development of angiogenesis-inhibiting compounds to treat retinal disorders.

The promise of 2004, that new anti-vascular endothelial growth factor (VEGF) treatments for age-related macular degeneration (AMD) be developed, came to fruition in 2005, much to the excitement of ophthalmologists. These emerging treatments for AMD took center stage this year and resulted in numerous ideas about the effect of the pharmaceutical advancements and their impact on other retinal diseases.

Basel, Switzerland—Novartis will work with Senju Pharmaceutical Co. to develop and commercialize a topical treatment for glaucoma.

Paris—Fovea Pharmaceuticals SA, a biopharmaceutical company working to discover, develop, and commercialize drugs to treat retinal diseases, announced the closing of a $25 million equity financing round.

Rockville, MD—The FDA has approved PrimaPharm Inc.'s new drug application for a new formulation for hyaluronidase injection (Hydase).

Do you know how sometimes people or groups assert something to be true, but it just doesn't seem to make sense? For me, this was always true with discussions about "direct-to-physician" (DTP) marketing activities by pharmaceutical companies.