Pharmacy

Rochester, NY—In a move designed to jump-start its Asian sales, Bausch & Lomb has agreed to buy a 55% share in China's leading ophthalmic pharmaceutical company for $200 million.

Montr?al—Intravitreal injection with the anti-VEGF antibody ranibizumab [(formerly RhuFab) Lucentis, Genentech] has been associated with impressive results in the treatment of minimally classic and occult choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD), according to the 1-year outcomes of a phase III trial.

New Orleans—Results of a retrospective study evaluating outcomes in eyes with an Ahmed Glaucoma Valve (AGV, New World Medical) implanted indicate that the FP7 model with its silicone flexible plate affords better IOP control than the S2 model featuring a rigid polypropylene plate.

The shunt is also novel because it allows surgeon control of the amount of fluid that flows from one area to another, a feat made possible in part by the selection of gold for its construction.

New Orleans—Results of a retrospective study evaluating outcomes in eyes with an Ahmed Glaucoma Valve (AGV, New World Medical) implanted indicate that the FP7 model with its silicone flexible plate affords better IOP control than the S2 model featuring a rigid polypropylene plate.

Alcon Laboratories is currently awaiting FDA approval for marketing of its LADAR 6000, a completely new laser built with customized ablation procedures in mind.

Washington, DC—The crystalens (eyeonics), an accommodating IOL approved for use in cataract patients, provides distance, intermediate, and near vision 3 years after implantation that are slightly better than the 1-year results. Optical tilt or optic flexure with induced astigmatism in conjunction with the traditional mechanism of action is hypothesized to play a role in the near visual acuity, according to Steven J. Dell, MD, speaking at the American Society of Cataract and Refractive Surgery (ASCRS) annual meeting.

Oakbrook Terrace, IL—The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) will try to improve communications among caregivers and improve medication safety as part of its 2006 National Patient Safety Goals and Requirements.

Washington, DC—Results of a clinical trial demonstrate the efficacy and safety of the investigational nonsteroidal anti-inflammatory drug (NSAID) nepafenac 0.1% ophthalmic suspension (Alcon Laboratories) for reducing anterior segment inflammation and minimizing pain after cataract surgery, said Stephen S. Lane, MD, at the annual meeting of the American Society of Cataract and Refractive Surgery.

Cleveland—A privately held biotechnology company said it has developed a proprietary non-viral nucleic acid nanoparticle technology that can introduce DNA into cells of the retina and other optic tissues.

These observations—together with recent studies that have identified specific auto-antigens in melanin-containing cells—support the idea that VKH disease is an autoimmune disorder.

Washington, DC—Safety monitoring in the phase III clinical studies of topical bromfenac sodium 0.09% (Xibrom, ISTA Pharmaceuticals) shows no detectable systemic absorption or evidence for treatment-related liver toxicity in patients treated for up to 2 weeks with this twice-daily ophthalmic nonsteroidal anti-inflammatory drug (NSAID), reported Eric D. Donnenfeld, MD, at the annual meeting of the American Society of Cataract and Refractive Surgery.

Irvine, CA—ISTA Pharmaceuticals is seeking FDA approval to start phase III studies of a new combination ophthalmic product containing tobramycin and prednisolone acetate to treat steroid-responsive inflammatory ocular conditions that risk bacterial infection.

Key Biscayne, FL—In a small, phase II clinical trial of squalamine lactate (Evizon, Genaera Corp.), a systemically delivered drug for the treatment of choroidal neovascularization (CNV) associated with age-related macular degeneration (AMD), all patients who received a 40-mg dose had preserved or improved vision through a 4-month study period, reported Carl Regillo, MD, FACS.

Key Biscayne, FL—Preliminary analyses from a phase II study demonstrate the feasibility of dye-enhanced photocoagulation (DEP) feeder vessel treatment (FVT) in eyes with minimally classic choroidal neovascularization (CNV) associated with age-related macular degeneration (AMD). This new technique may have benefits compared with laser photocoagulation FVT alone for both increasing the efficiency of the procedure and allowing for treatment of larger diameter vessels, said Giovanni Staurenghi, MD, at the annual meeting of the Macula Society.

Key Biscayne, FL—In a small, phase II clinical trial of squalamine lactate (Evizon, Genaera Corp.), a systemically delivered drug for the treatment of choroidal neovascularization (CNV) associated with age-related macular degeneration (AMD), all patients who received a 40-mg dose had preserved or improved vision through a 4-month study period, reported Carl Regillo, MD, FACS.

On Dec. 17, 2004, the FDA approved pegaptanib sodium (Macugen, Eyetech Pharmaceuticals) for the treatment of choroidal neovascularization (CNV) associated with age-related macular degeneration (AMD).

For senior executives at Eyetech Pharmaceuticals, New York, the 24 mm that encompass the eye—and in particular the back of the eye—is a vast frontier waiting to be explored. The small biotech company sees it as an opportunity to deliver medical solutions for the betterment of patients who suffer from blinding eye diseases. This is the direction that Eyetech is taking its future.

On April 11, Bausch & Lomb announced that it had received FDA approval to market its intravitreal fluocinolone acetonide implant 0.59 mg (Retisert) for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye.

Miami—Soothe Emollient Eye Drops (Alimera Sciences Inc.) is a welcome addition to the products available to treat dry eye disease. The eye drops help to supplement the oil in the lipid layer in the eye, which in turn helps improve the quality of the tear film.

Fort Lauderdale, FL—Results of a randomized, investigator-masked clinical study reinforce the usefulness of an existing unit-dose, emulsion-based artificial tear formula (Refresh Endura, Allergan) for improving the signs and symptoms of dry eye. In addition, outcomes show that an investigational multi-dose version formulated with a "vanishing" oxidative preservative (Purite) offers equally favorable efficacy, safety, and patient acceptability.

In a 24/7 world, the availability of the PureVision Toric Contact Lens (Bausch & Lomb) that incorporates an aspheric design is welcome news. The FDA approval in early April of the silicone hydrogel contact lens will offer patients who wear their lenses for long periods—even overnight—a healthy and more comfortable alternative to traditional hydroxyethylmethacrylate (HEMA) contact lenses.

Results from the FDA Investigational Device Exemption trial of the Model 1 epiretinal prosthesis show that implanted patients are able to interpret patterned electrical stimulation, localize high contrast objects, and recognize motion, reported Mark S. Humayun, MD, of the Doheny Eye Institute at the University of Southern California.

Recent advances in biotechnology and tissue engineering are providing promise that in the future, tissue replacements or renewal techniques might be used to restore lost vision in eyes with genetic, malignant, or degenerative diseases.

Irvine, CA—Allergan Inc. has signed an exclusive licensing agreement with Japan's Sanwa Kagaku Kenkyusho Co. Ltd. to develop and commercialize Posurdex for the ophthalmic marketplace in that country.

The AcrySof ReSTOR apodized diffractive IOL (Alcon Laboratories Inc.) recently received FDA approval for cataract patients with and without presbyopia. In clinical trials, 80% of patients reported never wearing reading glasses or bifocals following cataract surgery and implantation of the new lens.

ISTA Pharmaceuticals has filed an investigational new drug application with the FDA to initiate a phase III study of a new combination ophthalmic product containing tobramycin and prednisolone acetate for the treatment of steroid-responsive inflammatory ocular conditions where risk of bacterial infection exists.

Novagali Pharma, a biopharmaceutical company based in Evry, France, which develops innovative drug delivery systems in ophthalmology, has appointed seven individuals to its scientific advisory board. The company chose experts from America, Japan, Israel, and France.

The ingenuity of pharmaceutical researchers continues to amaze in their bility to devise inventive solutions and improve upon our current arsenal of ophthalmic medications, devices,and delivery systems.

Multiple sclerosis (MS) can present to the ophthalmologist with visual loss (e.g., opticneuritis), diplopia (e.g., internuclear ophthalmoplegia [INO] or sixth-nerve palsy), or nystagmus.