Vistakon Pharmaceuticals Introduces IQUIX® (levofloxacin Ophthalmic Solution) 1.5% – A Milestone in the Treatment of Corneal Ulcers

Vistakon® Pharmaceuticals, LLC.

IQUIX provides broad coverage of the most sight-threatening gram-negative and the most prevalent gram-positive ocular pathogens

JACKSONVILLE, Fla. (October 29, 2007) – VISTAKON® Pharmaceuticals, LLC, today announced the introduction of IQUIX® (levofloxacin ophthalmic solution) 1.5% ocular anti-infective medication – the only newer-generation fluoroquinolone approved by the U.S. Food and Drug Administration for the treatment of corneal ulcers.

IQUIX is a sterile topical ophthalmic solution containing 1.5% levofloxacin. IQUIX rapidly penetrates corneal tissue and provides broad coverage of the most sight-threatening gram-negative and the most prevalent gram-positive pathogens, including Cornyebaterium species, Staphyloccus aureus, Staphyloccus epidermis, Streptococcus pneumoniae, Viridans group streptococci, Pseudomonas aeruginosa, and Serratia marcescens.

“The introduction of IQUIX marks a milestone in the treatment of corneal ulcers,” says Penny A. Asbell, M.D., Professor of Ophthalmology, Director of Cornea Services, External Disease, and Refractive Surgery, Mount Sinai School of Medicine in New York. “Compared to existing ophthalmic fluoroquinolones, IQUIX offers a higher sustained concentration option. This – paired with its dual mechanism of action – provides a new and important option for doctors’ corneal ulcer treatment.”

IQUIX eradicates targeted pathogens by inhibiting both topoisomerase IV and DNA gyrase – a dual mechanism of action similar to newer fluoroquinolones. Resistance to levofloxacin due to spontaneous mutation in vitro is a rare occurrence (10-9 to 10-10). IQUIX is preservative free. Levofloxacin, when tested in human cell cultures, demonstrated less cytotoxicity than other marketed fluoroquinolones1.

IQUIX is contraindicated in patients with a history of hypersensitivity to levofloxacin, to other quinolones, or to any of the components in this medication. IQUIX was well-tolerated in clinical trials. The ocular adverse events occurring in 1%-2% of patients included decreased/blurred vision, instillation site irritation/discomfort, ocular infection, and ocular pain/discomfort. The non-ocular adverse events occurring in approximately 8%-10% of patients were headache and taste disturbance. For more complete information on warnings and precautions, please see product insert, visit www.IQUIX.com, or call 1-800-523-6225, option 2 & 3.

Vistakon Pharmaceuticals, LLC

Vistakon Pharmaceuticals, LLC, specializes in the sales and marketing of ophthalmic pharmaceuticals. Headquartered in Jacksonville, Florida, the company markets four prescription ophthalmic agents: ALAMAST® (pemirolast potassium ophthalmic solution) 0.1%, BETIMOL® (timolol ophthalmic solution) 0.25% and .5%, IQUIX® (levofloxacin ophthalmic solution) 1.5%, and QUIXIN® (levofloxacin ophthalmic solution) 0.5% through a co-marketing agreement with Santen Incorporated.

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ALAMAST and BETIMOL are registered trademarks of Santen Pharmaceutical, Co., Ltd., Osaka, Japan. IQUIX and QUIXIN are licensed trademarks of Daiichi-Sankyo Co., Ltd., Tokyo, Japan, manufactured by Santen Oy, Tampere, Finland, and marketed by VISTAKON® Pharmaceuticals, LLC. VISTAKON® is a registered trademark of VISTAKON® Pharmaceuticals, LLC, Jacksonville, Florida.

1Skelnick DL, Clark LA, Bezwada P. In vitro effect of drug concentration and exposure time of levofloxacin, ofloxacin, ciprofloxacin, gatifloxacin, and moxifloxacin on human corneal endothelial cells and keratocytes. Presented at ARVO Annual Meeting; May 4-9, 2003. Ft. Lauderdale, Fla. Poster #4739.

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