Pharmacy

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.

Currently, health-care providers could be accessing information that is as much as1 year out-of-date.

Chicago—Nepafenac ophthalmic suspension 0.1% (Nevanac, Alcon Laboratories) is a significant advance in the treatment of pain and inflammation associated with cataract surgery. The nonsteroidal anti-inflammatory prodrug offers well-tolerated, effective, target-specific therapy that may enhance patient compliance and quality of vision outcomes, said Robert P. Lehmann, MD, FACS, at the annual meeting of the American Academy of Ophthalmology.

A new and promising therapeutic approach to treating diseases in which abnormal protein production is a problem, including AMD, is known as RNA interference (RNAi). RNAi is a biological method of turning off specific disease-causing genes and is being tested in at least two trials involving patients with AMD.

Irvine, CA—Allergan Inc. announces it has received FDA approval to market its brimonidine tartrate ophthalmic solution 0.1% (Alphagan P) for the lowering of IOP in patients with primary open-angle glaucoma or ocular hypertension.

Ophthalmologists who are clinical investigators will likely be affected by new trial registration policies if they intend to publish research in top-tier journals.

Research into the genetics of ocular disease is paying off with discoveries of new genes associated with both common and rare eye conditions. Gene therapy, however, could be 5 to 10 years away for many eye diseases. In this first of a two-part series, researchers explain the progress in age-related macular degeneration (AMD), Leber's congenital amaurosis, and familial exudative vitreoretinopathy (FEVR). In the second half of the series, gains in glaucoma, myopia, and retinitis pigmentosa will be covered as well as a promising therapy for AMD—RNA interference.

New therapeutic treatments and medication for wet age-related macular degeneration (AMD) will alter management for the thousands of patients who have been diagnosed with AMD or who are at risk of developing the disease.

Eyetech Pharmaceuticals Inc. announced on Monday the enrollment of the first patient in a phase III randomized, controlled, double-masked, multicenter, comparative dose-finding trial that will compare the safety and efficacy of pegaptanib sodium injection (Macugen) in patients with diabetic macular edema (DME).

A number of compounds are either available or under investigation to treat wet age-related macular degeneration (AMD), offering some hope to patients and clinicians, said Michael J. Tolentino, MD, of Winter Haven, FL.

Sometimes physicians, nurses, pharmacists, and other health-care providers make mistakes. A few statistics generated by the Institute of Medicine, the Centers for Disease Control and Prevention, and others highlight the problem.

The preliminary 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 Schwartz, MD, who reported the findings of the Macugen Diabetic Retinopathy Study Group during the retina subspecialty day at the American Academy of Ophthalmology annual meeting.

Sometimes physicians, nurses, pharmacists, and other health-care providers make mistakes. A few statistics generated by the Institute of Medicine, the Centers for Disease Control and Prevention, and others highlight the problem.

Montr?al—The exploratory phase II trial of pegaptanib sodium (Macugen, OSI/Eyetech Pharmaceuticals/Pfizer) for the treatment of diabetic macular edema (DME) showed that the drug is safe, effective, and well tolerated. The patients who received the 0.3-mg dose of pegaptanib sodium achieved a better visual acuity level than those who received sham treatment, and they had more of a reduction in the central retinal thickness.

CE approval has been granted for SOLX?s 24-karat DeepLight Gold Micro-Shunt (GMS), which is available for sale outside the United States for the first time.

After a priority 6-month review, the FDA approved nepafenac ophthalmic suspension 0.1% (Nevanac, Alcon Laboratories), a novel nonsteroidal anti-inflammatory prodrug, for the treatment of pain and inflammation associated with cataract surgery.

Richfield, MN—A small compounding pharmacy near Minneapolis is recalling some lots of its trypan blue 0.06% ophthalmic solution after a customer said two patients who used it had symptoms of bacterial infection.

Colorado Springs, CO—On Sept. 1, Advanced Medical Optics (AMO) launched its Tecnis foldable acrylic IOL (ZA9003) in the United States after receiving FDA approval for marketing in August.

South San Francisco—Genentech Inc. said it intends to file a complete Biologics License Application (BLA) in December for its ranibizumab (Lucentis) treatment for the wet form of age-related macular degeneration (AMD). In addition, the company said it was recently notified that the FDA denied a request for fast-track designation for the investigational drug, which would allow for a rolling BLA submission.

After a priority 6-month review, the FDA approved nepafenac ophthalmic suspension 0.1% (Nevanac, Alcon Laboratories), a novel nonsteroidal anti-inflammatory prodrug, for the treatment of pain and inflammation associated with cataract surgery.

New York—The $935 million acquisition of Eyetech Pharmaceuticals Inc. by OSI Pharmaceuticals Inc. will boost research and development (R&D) opportunities for both companies, while preserving Eyetech's integrity as a stand-alone business unit, according to leaders of both organizations.

Washington, DC—Members of the House of Representatives are expected to consider this fall a bill that identifies all contact lenses as medical devices that should be regulated by the FDA.

Lisbon, Portugal - Recent data on the crystalens accommodating IOL (eyeonics) indicate there is a slight-but-noticeable improvement in distance and near visual performance as follow-up is lengthening. The results also suggest an additional mechanism of action may account for the better-than-expected near vision outcomes being seen in some patients, said Steven Dell, MD.

Fort Lauderdale, FL—A new study offers hope that the serious adverse effects of carboplatin chemotherapy for retinoblastoma could be minimized by local delivery in a fibrin sealant sustained-release vehicle.

Orangeburg, NY—The low-dose modified corticosteroid loteprednol etabonate ophthalmic suspension 0.2% (Alrex, Bausch & Lomb) is effectively used during the acute phase of seasonal allergic conjunctivitis, according to Ayman Matta, MD, PC, FACS.

New York—Pegaptanib sodium injection (Macugen) has won recognition as a major scientific breakthrough from an organization accustomed to novel pharmaceutical products. The drug, the first FDA-approved treatment for wet age-related macular degeneration (AMD), was named Innovative Pharmaceutical Product of the Year at the 2005 Pharmaceutical Achievement Awards.

Columbus, OH—Vision researchers, eyecare specialists, bioscientists, public health, and government leaders gathered recently here in what is billed as a unique opportunity to foster collaboration in the study of vision and aging.

Fort Lauderdale, FL—Ketorolac tromethamine 0.4% ophthalmic solution (Acular LS, Allergan) may be a useful adjunct for improving patient comfort and treatment compliance during the induction phase of dry eye therapy with cyclosporine 0.05% ophthalmic emulsion (Restasis, Allergan), Barry A. Schechter, MD, said to colleagues at the annual meeting of the Association for Research in Vision and Ophthalmology here.

Los Angeles—The medical management of age-related macular generation (AMD) has progressed by leaps and bounds in a very short space of time and generated a great deal of excitement among retina specialists. In particular, translational research has resulted in a large number of drugs that target choroidal neovascularization (CNV).

Tarrytown, NY—Regeneron Pharmaceuticals Inc. will begin a phase I trial to evaluate the safety and tolerability of its "VEGF Trap" on patients with the wet form of age-related macular deneration.