FDA Approves Zymaxid
Allergan Receives FDA Approval for Zymaxid Ophthalmic Solution
IRVINE, Calif.--(BUSINESS WIRE)--May 19, 2010 - Allergan, Inc. 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:
|Streptococcus mitis group*
|*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.
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.
About Allergan, Inc.
Allergan, Inc. is a multi-specialty health care company established 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life's potential. Today, we have more than 8,000 highly dedicated and talented employees living in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics and medical devices, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including ophthalmology, neurosciences, obesity, urologics, medical aesthetics and dermatology, Allergan is proud to celebrate 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work.
This press release contains "forward-looking statements," including statements by Dr. Whitcup, and other statements regarding the safety, effectiveness, approvals, adverse events and market potential of Zymaxid. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things, general industry and pharmaceutical market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to product marketing, such as the unpredictability of market acceptance for new products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations. Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2009 Form 10-K and Allergan's Form 10-Q for the quarter ended March 31, 2010. Copies of Allergan's press releases and additional information about Allergan is available on the World Wide Web at www.Allergan.com or you can contact the Allergan Investor Relations department by calling (714) 246-4636.
© 2010 Allergan, Inc. Irvine, CA 92612. ® and ™ marks owned by Allergan, Inc.
1 Data on file, Allergan, Inc. 2010.
Caroline Van Hove, (714) 246-5134 (media)
Crystal Muilenburg, (714) 246-5842 (media)
Jim Hindman, (714) 246-4636 (investors)
Joann Bradley, (714) 246-4766 (investors)
Emil Schultz, (714) 246-4474 (investors)
Posted: May 2010