Allergan Receives FDA Approval For ZYMAXID™ Ophthalmic Solution

Main Category: Eye Health / Blindness
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 20 May 2010 - 17:00 PDT

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Allergan, Inc. (NYSE: AGN) today announced that the United States Food and Drug Administration (FDA) has approved ZYMAXID™ (gatifloxacin ophthalmic solution) 0.5%, a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms; Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group*, Streptococcus oralis*, Streptococcus pneumonia. ZYMAXID™ is now the highest concentration gatifloxacin ophthalmic solution on the market in the United States.

ZYMAXID™ contains 0.5% gatifloxacin, a well-established fluoroquinolone, and is formulated with the preservative benzalkonium chloride (BAK). In clinical studies, ZYMAXID™ ophthalmic solution demonstrated a statistically superior eradication of bacterial conjunctivitis - approximately 90 percent (301/333) versus 70 percent (228/325) for vehicle (the recommended dosage is one drop every two hours in the affected eye(s) while awake, up to eight times on Day one and then two to four times daily while awake on Days two through seven).1 ZYMAXID™ is efficacious against a broad spectrum of gram-positive and gram-negative pathogens.

"As pathogens continue to evolve and become more resistant to antibiotics, it is important to develop more potent formulations of anti-infective drugs," said Scott Whitcup, M.D., Allergan's Executive Vice President, Research and Development and Chief Scientific Officer. "Allergan has a history of innovation in ocular anti-infective drugs dating back to OCUFLOX® ophthalmic solution in the early 1990s, and we are pleased to offer a new option to eye care professionals and their patients."

The efficacy of ZYMAXID™ ophthalmic solution was assessed in two multicenter, double-masked, randomized dual-arm comparison studies involving 1,437 patients receiving either ZYMAXID™ or vehicle. In the clinical studies, the efficacy of ZYMAXID™ was defined as complete clearance of conjunctival hyperaemia and conjunctival discharge, and when all bacterial species present at baseline were eradicated. Results of these studies demonstrated that at Day six, complete clearance of conjunctival hyperaemia and conjunctival discharge was achieved in 58 percent of patients (193/333) treated with ZYMAXID™ ophthalmic solution compared to 45 percent (148/325) in the vehicle group.

ZYMAXID™ is expected to be available to physicians and patients in the United States in June 2010.

* Efficacy for this organism was studied in fewer than 10 infections.

Indications And Usage

ZYMAXID™ (gatifloxacin ophthalmic solution) 0.5% solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms

Aerobic Gram-Positive Bacteria:
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus mitis group*
Streptococcus oralis*
Streptococcus pneumoniae

*Efficacy for this organism was studied in fewer than 10 infections.

Dosage And Administration

Patients one year of age or older: Instill one drop every two hours in the affected eye(s) while awake, up to eight times on Day one. Instill one drop two to four times daily in the affected eye(s) while awake on Days two through seven.

Important Safety Information

Warnings And Precautions

ZYMAXID™ solution should not be introduced directly into the anterior chamber of the eye. As with other anti-infectives, prolonged use of ZYMAXID™ may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis or during the course of therapy with ZYMAXID™.

Adverse Reactions

The most frequently reported adverse reactions occurring in > 1% of patients in the gatifloxacin study population (N=717) were: worsening of the conjunctivitis, eye irritation, dysgeusia, and eye pain.

Additional adverse events reported with other formulations of gatifloxacin ophthalmic solution include chemosis, conjunctival hemorrhage, dry eye, eye discharge, eyelid edema, headache, increased lacrimation, keratitis, papillary conjunctivitis, and reduced visual acuity.

1 Data on file, Allergan, Inc. 2010.

Source
Allergan, Inc.

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