Pharmacy

Boca Raton, FL-New FDA-approved technology (Vision Restoration Therapy, Nova Vision Inc.) delivers a custom-designed pattern of light of varying intensity to the edges of the visual field to increase the field in patients whose vision is impaired due to stroke, according to recently reported research.

Boca Raton, FL-New FDA-approved technology (Vision Restoration Therapy, Nova Vision Inc.) delivers a custom-designed pattern of light of varying intensity to the edges of the visual field to increase the field in patients whose vision is impaired due to stroke, according to recently reported research.

Irvine, CA-ISTA Pharmaceuticals Inc. plans to file a supplemental new drug application with the FDA later this year based on preliminary results and pending further analyses of a phase III trial of its once-daily formulation of bromfenac sodium ophthalmic solution (Xibrom). If approved, this formulation of the topical non-steroidal anti-inflammatory drug (NSAID) would become the only once-daily treatment for ocular pain and inflammation after cataract surgery.

Jersey City, NJ-The FDA has granted orphan drug designation to two investigational therapeutics of Lux Biosciences, a privately held biotechnical company specializing in treatments for ophthalmic diseases.

Chapel Hill, NC-Lantibio Inc. and TRB Chemedica have begun a phase III clinical trial with VISMED, a patented formulation containing sodium hyaluronate, to treat dry eye syndrome.

Rochester, NY-Bausch & Lomb has purchased Alimera Sciences' over-the-counter allergy franchise, including ketotifen fumarate ophthalmic solution 0.025% (Alaway), which was recently approved by the FDA.

Lynbrook, NY-Ketotifen fumarate ophthalmic solution 0.025% (Zaditor, Novartis) offers potent, fast-acting treatment for the signs and symptoms of ocular allergy with excellent safety and the convenience of availability as an over-the-counter (OTC) medication, said Marguerite B. McDonald, MD.

Irvine, CA-Visiogen Inc. has received FDA approval to expand the phase III clinical trial of its dual-optic accommodating IOL (Synchrony) in the United States.

San Diego-TargeGen has begun a phase I trial of a topical drug to treat age-related macular degeneration (AMD).

Exton, PA-Othera Pharmaceuticals Inc. has begun enrollment for a phase II clinical trial of its topical eye drop OT-551 in patients with bilateral geographic atrophy (GA), an advanced form of dry age-related macular degeneration (AMD).

Irvine, CA-ISTA Pharmaceuticals Inc. has submitted an investigational new drug application with the FDA for its eye-drop formulation of bepotastine to treat allergic conjunctivitis.

Rochester, NY-Bausch & Lomb has purchased the over-the-counter (OTC) allergy franchise of Alimera Sciences Inc., a privately held company based in Atlanta.

St. Petersburg, FL-Lenstec Inc. says the FDA has granted it an investigational device exemption to begin a clinical trial of the Softec HD posterior chamber IOL.

Fort Worth, TX-The presence of mold in multiple bottles of Systane Free Liquid Gel has forced Alcon Laboratories Inc. to issue a voluntary recall of the product.

Fort Worth, TX-The presence of mold in multiple bottles of Systane Free Liquid Gel has forced Alcon Laboratories Inc. to issue a voluntary recall of the product.

New York-The use of a scleral spacing procedure using PreView Scleral Implants (Refocus Group Inc.) appears to improve the technique to correct presbyopia. This revised technique seems to be a safe and effective method of improving near visual acuity without affecting distance visual acuity in emmetropic presbyopia, according to Barrie D. Soloway, MD, FACS.

Jersey City, NJ-Now that the 30-day waiting period has ended for the investigational new drug application filed by Lux Biosciences Inc. for the development of LX211 in uveitis, the company will begin three controlled, double-masked clinical trials of the next-generation calcineurin inhibitor in early 2007. The studies collectively will enroll more than 500 patients in North America and Europe.

Union City, CA-MacuSight Inc., a developer of innovative therapeutics for the treatment of severe ocular diseases and conditions, announced the appointment of Brian C. Cunningham to its board of directors.

Union City, CA-MacuSight Inc. is beginning a phase I study of its lead product candidate in patients with diabetic macular edema (DME).

Indianapolis, IN-Eli Lilly and Co. said it is "weighing its options" regarding further development of ruboxistaurin mesylate after the FDA requested an additional 3-year, phase III clinical trial of the molecule that could treat severe nonproliferative diabetic retinopathy.

San Diego-TargeGen Inc. has initiated a single-site phase I clinical trial involving TG100801, a small molecule, topically applied multi-targeted kinase inhibitor for the treatment of age-related macular degeneration (AMD) and other debilitating diseases of the eye.

East Hanover, NJ-The FDA has approved the over-the-counter (OTC) 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.

Novagali Pharma, a French biopharmaceutical company specializing in ophthalmology, has completed the enrollment for its phase III study to evaluate the efficacy and safety of a potential treatment for vernal keratoconjunctivitis (VKC). Enrollment for the international study was completed much earlier than expected, the company said, indicating an unmet need for a treatment.

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.