Pharmacy

The first one-bottle daily lens-care system for rigid gas permeable (RGP) contact lenses will be available this month from Bausch & Lomb. The FDA approved Boston Simplus Multi-Action Solution in May.

Fort Lauderdale, FL-Novartis Ophthalmics and QLT Inc. have received the 2003 Helen Keller Prize for Innovation in Eye Care for their development of verteporfin for injection (Visudyne) therapy.

Alameda, CA-InSite Vision Inc. has initiated a phase I clinical study with ISV-403, a treatment for ocular bacterial infections.

San Diego-ACADIA Pharmaceuticals will collaborate with Allergan Inc. to develop eye-care applications related to chemistries that ACADIA has identified for a wide range of G-protein coupled receptor and nuclear receptor targets.

When prescribing ophthalmic drugs, the decision of whether to opt for a generic substitute involves greater consideration than may be required for a systemic agent.

Saratoga, CA-A pivotal trial has begun with the implantable miniature telescope (IMT) (VisionCare Ophthalmic Technologies Inc., Saratoga, CA), a low vision IOL for patients with age-related macular degeneration (AMD), following a successful phase I trial. In that trial, most patients gained three or more lines of near or distance visual acuity and improved their ability to perform daily activities.

The FDA has approved the expansion of the clinical trial of Anamed Inc.'s Perma-Vision intracorneal lens for the correction of hyperopia up to +6 D.

New York-Eyetech Pharmaceuticals Inc.'s sales force will help sell Pfizer Inc.'s once-daily latanoprost ophthalmic solution (Xalatan) to U.S. ophthalmologists.

Dallas-Moxifloxacin ophthalmic solution (Vigamox 0.5%, Alcon Laboratories) was approved by the FDA on April 16 for the treatment of bacterial conjunctivitis, following a 6-month review of the drug.

Grants Pass, OR-A product using tissue-culture-grade water delivered through an ultra-fine mist claims to restore the moisture volume of the eye's tear film without disrupting the tear film's delicate structure.

The FDA is looking for more analysis of data before deciding whether to approve ISTA Pharmaceuticals' ovine hyaluronidase compound for the treatment of vitreous hemorrhage.

Clinical practice experience is confirming the results from premarketing clinical trials that showed a new over-the-counter artificial tear product (Systane, Alcon) is a novel approach for modulating the signs and symptoms of dry eye.

Maui, HI-FDA approval of Restasis (cyclosporine ophthalmic emulsion, 0.05%, Allergan, Irvine, CA), in December opened a new door for patients with dry eye disease by offering two important "firsts": the drug provides more than palliation of dry eye symptoms, and it targets the inflammation that is the underlying cause of dry eye disease. It may even effect a cure in some patients. The drug became commercially available early last month.

CA-The FDA approval of gatifloxacin ophthalmic solution 0.3% (Zymar, Allergan) marks a milestone as the first fourth-generation fluoroquinolone to enter the ophthalmic market. The therapy for the treatment of bacterial conjunctivitis caused by susceptible strains of bacteria also has a unique mechanism to prevent development of antibiotic resistance, according to Allergan.

Boston-Ophthalmic solutions of azelastine HCl (Optivar, Asta Medica/Muro Pharmaceutical Inc., Tewksbury, MA) and olopatadine HCl (Patanol, Alcon Laboratories, Fort Worth, TX) both effectively inhibit the activation of normal cultured human mast cells and the release of interleukin-6 (IL-6), tryptase, and histamine. However, azelastine seemed to be substantially more potent for treating ocular allergy when the two drugs were compared in an in vitro study.

Boston-The mast-cell stabilizer pemirolast potassium 0.1% (Alamast, Santen) is a safe, comfortable, and effective agent for preventing and relieving ocular itching of seasonal allergic conjunctivitis throughout the allergy season, according to a pooled analysis of data from phase III trials.

Ophthalmic drops that combine immediate antihistamine relief with prophylactic care in the form of mast cell inhibition and eosinophil blockage are the mainstay of therapy for allergic conjunctivitis.

New York-The planned merger of pharmaceutical giants Pfizer Inc. and Pharmacia Corp. has passed the scrutiny of the Federal Trade Commission, provided the companies sell off certain products that raised antitrust concerns.

Irvine, CA-ISTA Pharmaceuticals is regrouping after an FDA advisory committee said the company's tests of ovine hyal-uronidase (Vitrase) failed to demonstrate sufficient statistical evidence to support its efficacy in treating vitreous hemorrhage.

Boston-Multiple intravitreal injections of rhuFab V2 (Genentech Inc., San Francisco) are well-tolerated and appear to have favorable biologic activity for the treatment of exudative age-related macular degeneration (AMD), said Jeffrey S. Heier, MD, of Ophthalmic Consultants of Boston and the Center for Eye Research, principal investigator for that trial.

Washington, DC-The Pharmaceutical Re-search and Manufacturers of America (PhRMA) announced that a new online database is now available to help patients without prescription drug coverage find information about patient assistance pro-grams.

Andover, MA-The antibiotic ISV-401 (InSite Vision, Alameda, CA) in development to treat acute bacterial conjunctivitis has achieved a bacterial eradication rate of 85% by the third day of treatment and 90% by 7 to 9 days, according to a phase II clinical trial.

Rochester, NY-On the same day Bausch & Lomb celebrated FDA approval of a larger treatment range for its Technolas 217A excimer laser system, it said it would delay a year before asking the FDA to approve its Retisert drug-delivery implant.

Irvine, CA-Refractec Inc. has completed patient enrollment for its phase III clinical trial for conductive keratoplasty (CK) as a treatment for presbyopia.

Greensboro, NC-Nidek will introduce the MP-1 Micro Perimeter in the United States and globally following FDA approval of its combined perimetry and fundus imaging instrument.