Pharmacy

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.

A number of studies have been conducted and presented during a free paper session, supporting Alcon's research into its investigational AcrySof angle-supported phakic intraocular lens (IOL).

Athenagen Inc. began a phase I clinical trial of mecamylamine (ATG003), its eye drop therapy for age-related macular degeneration (AMD). Animal models showed efficacy of ATG003 as an alternative to current AMD therapies, which require needle injections directly in the eye. The randomized, placebo-controlled, ascending dose clinical trial is designed to evaluate ocular tolerability and safety for up to 14 days.

Advanced Medical Optics Inc. (AMO) sold six over-the-counter eye-care products to Inyx Inc., which will assign all of the business and marketing rights to its wholly owned marketing subsidiary, Exaeris Inc.

The FDA sent an approval letter to Eli Lilly and Co. for ruboxistaurin mesylate (Arxxant), an investigational oral therapy for the treatment of diabetic retinopathy.

The FDA approved WaveLight’s wavefront-guided procedure, a LASIK treatment approach that combines the Allegro Analyzer with the 200-Hz Allegretto Wave excimer laser.

Aliso Viejo, CA-Since FDA approval in 2003, more than 50,000 crystalens accommodating IOLs (eyeonics) have been implanted worldwide. Of these, 17,000 implants were with the crystalens SE second-generation lens (introduced in 2005), the company said in a prepared statement.

Irvine, CA-Visiogen Inc.'s dual-optic accommodating IOL (Synchrony) has received CE Mark designation.

Irvine, CA-ISTA Pharmaceuticals Inc. announced it has filed a New Drug Application (NDA) with the FDA for its investigational ophthalmic product (T-Pred) containing tobramycin and prednisolone acetate in a fixed combination. The company hopes the drug receives approval as a treatment for inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial ocular infections or a risk of bacterial infections exists.

Charleston, SC-The brimonidine 0.2%/ timolol 0.5% fixed combination (Combigan, Allergan) administered twice daily is as effective as the concurrent use of brimonidine and timolol and is significantly more effective than monotherapy with either brimonidine three times daily or timolol twice daily, according to E. Randy Craven, MD, who presented his results at the American Glaucoma Society meeting here. The fixed combination is also superior to brimonidine monotherapy in long-term safety and the development of fewer ocular allergies, Dr. Craven said.

Azelastine is formulated to have a very long half life and a very high affinity for the H1 receptor it affects.

San Francisco-Discontinuing the use of cyclosporine ophthalmic emulsion 0.05% (Restasis, Allergan), the only FDA-approved drug to treat dry eye, may result in recurrence of the signs and symptoms of keratoconjunctivitis sicca (KCS), and reinstitution of the drug is needed to reverse those signs and symptoms, John Sheppard, MD, reported at the annual meeting of the American Society of Cataract and Refractive Surgery.

Commonly used systemic antihistamines taken for seasonal allergies can cause ocular surface drying that in turn aggravates ocular allergy symptoms. Antihistamine drops specifically formulated for ocular allergies, in contrast, do not appear to decrease tear volume or tear flow or cause ocular surface damage, according to several investigators who have studied ocular drying. However, in a separate mouse study, topical ocular allergy medications themselves may have different effects on tear volume or tear flow.