Pharmacy

Biovitrum, a Stockholm-based biopharmaceutical company, has initiated a clinical phase II study with the candidate drug BVT.28949, a 5-HT2A antagonist for treating glaucoma.

In a retrospective analysis of the phase III MARINA study results, patients with neovascular age-related macular degeneration (AMD) who were treated with the 0.5-mg dose of ranibizumab (Lucentis, Genentech) had improvement in anatomic outcomes that corresponded to improved visual acuity and was compared to a sham group, according to Nancy M. Holekamp, MD.

Lenstec Inc. announced that the FDA has granted the company an Investigational Device Exemption (IDE) to begin a clinical trial of the Softec HD posterior chamber IOL.

Successful long-term management of glaucoma requires a full spectrum of tools. These may include new technologies and pharmaceutical agents as well as interventional approaches involving laser or surgical therapy.

Ruboxistaurin (Arxxant, Eli Lilly) may be a useful new tool to prevent visual loss from diabetic retinopathy based on the results of the DRS2 Study, reported Lloyd Aiello, MD, PhD, during Retina Subspecialty Day. The study showed a reduction in the sustained vision loss compared with placebo. A total of 685 patients with type 1 or type 2 diabetes participated in this multicenter randomized phase III clinical study that was completed late in 2005, according to Dr. Aiello. He is associate professor of ophthalmology, Harvard Medical School, and investigator and head of eye research, Joslin Diabetes Center, Boston.

Miami-One year into a 2-year study using an optical coherence tomography (OCT)-guided variable dosing regimen for ranibizumab (Lucentis, Genentech) for neovascular age-related macular degeneration (AMD), two key findings have emerged, according to lead investigator Philip Rosenfeld, MD, PhD.

Columbia, SC-The Light Touch technique of conductive keratoplasty (CK, Refractec), developed by refractive specialist Henry L. "Rick" Milne, MD, shows promise in the correction of near vision in patients with presbyopia, explained Dr. Milne.

Vancouver, British Columbia-Peter Hnik, MD, MHS, has been named chief medical officer of iCo Therapeutics Inc. The biotechnology company is developing pre-existing drugs for a range of new conditions affecting isolated biologic environments-areas such as the eye, spinal cord, and joints, where locally administered application of these therapies would have minimal systemic distribution and fewer safety issues.

Waltham, MA-OxiGENE Inc., a clinical-stage biopharmaceutical company developing novel therapies to treat eye diseases and cancer, is now focusing its ophthalmology strategy on oral or other non-intravitreal forms of administration of Combretastatin A4 Phosphate (CA4P) for age-related macular degeneration.

Buffalo Grove, IL-Akorn Inc. has submitted the first abbreviated new drug application with the Office of Generic Drugs on behalf of FDC Ltd., India's second-largest manufacturer and marketer of ophthalmic pharmaceutical products.

Boston-Global bio-nanotech company pSivida Ltd. has begun a phase II clinical trial of the steroid receptor antagonist mifepristone (RU486) as an eye-drop treatment for steroid-associated elevated IOP. The investigator-sponsored trial is expected to involve up to 45 patients in the United States.

The FDA approved the over-the-counter use of ketotifen fumarate ophthalmic solution 0.025% (Zaditor) for the temporary prevention of itchy eyes due to allergic conjunctivitis. The drops treat eye itch associated with pollen, ragweed, grass, animal hair, and dander without the potentially negative effects of a decongestant.

Lux Biosciences Inc., a privately held biotechnology company specializing in ophthalmic diseases, announced it has entered into an exclusive license agreement with Rutgers, The State University of New Jersey, to access its polyarylate patent estate.

ISTA Pharmaceuticals acquired from Senju Pharmaceuticals an exclusive North American license to an eye-drop formulation containing bepotastine, an investigational ophthalmic treatment for allergic conjunctivitis. This is ISTA Pharmaceuticals' first license for the ophthalmic allergy field.

Las Vegas-Bausch & Lomb has received U.S. FDA approval to add a cold oxygen plasma treatment to the manufacturing process of gas permeable (GP) contact lenses made with Boston materials. B&L made the announcement recently at the American Optometric Association Congress and Annual American Optometric Student Association Conference.

Sydney, Australia-The first synthetic polymer corneal inlays implanted in humans appear to be biocompatible with corneal tissue and represent a safe, biologically acceptable alternative to other forms of refractive surgery, according to observations made over an 18-month period, said Deborah F. Sweeney, B Optom, PhD.

Paris-ExonHit Therapeutics SA, a drug and diagnostic discovery company, has extended its strategic collaboration with Allergan Inc., a global specialty pharmaceutical company, to identify, develop, and commercialize drugs targeted at the treatment of ophthalmologic conditions, neurodegenerative diseases, and pain, based on positive preclinical trial results.

San Francisco-Athenagen Inc., a privately held biopharmaceutical company, has begun phase I clinical testing of ATG003, its topical eye drop therapy for age-related macular degeneration (AMD).

Alcon Laboratories has received FDA approval to market a new, benzalkonium chloride (BAK)-free formulation of travoprost 0.004% ophthalmic solution (Travatan Z). Prescribers can expect the product to be available by the end of the month.

The FDA approved Alcon Laboratories’ travoprost ophthalmic solution 0.004% (Travatan Z) for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension, who are intolerant of, or have insufficient response to other IOP-lowering medication.

With the FDA approval of WaveLight AG's wavefront-guided LASIK treatment using the Allegro Analyzer for wavefront analysis in conjunction with the company's 200-Hz Allegretto Wave excimer laser, U.S. refractive surgeons now have another choice for their patients. The indication is for the reduction or elimination of up to –7 D of spherical equivalent myopia or myopia with astigmatism, with up to –7 D of spherical component and up to 3 D of astigmatic component at the spectacle plane.

Madison, WI-Results from a recent study have shown for the first time the potential of anti-vascular endothelial growth factor (VEGF) therapy to improve features of diabetic retinopathy, according to Micheal M. Altaweel, MD.

Alameda, CA-InSite Vision Inc. submitted a New Drug Application (NDA) to the FDA for a topical 1% azithromycin formulation (Aza-Site) for the treatment of bacterial conjunctivitis.

Las Vegas-Bausch & Lomb has received U.S. FDA approval to add a cold oxygen plasma treatment to the manufacturing process of gas-permeable (GP) contact lenses made with Boston materials. B&L made the announcement recently at the American Optometric Association Congress and Annual American Optometric Student Association Conference.

Santa Ana, CA-Advanced Medical Optics Inc. (AMO) has signed an agreement to sell the rights to six over-the-counter (OTC) eye-care products and the Lens Plus trade name to Inyx Inc., a New York-based specialty pharmaceutical company. The acquisition was expected to close last month.