Rx Pharmaceuticals
FDA Approves
Bausch & Lomb's Zylet®
Ophthalmic Combination Rx
Drug
FOR RELEASE
Wednesday, December 15, 2004
ROCHESTER, N.Y. - Bausch & Lomb
(NYSE:BOL) announced today that it has received U.S. Food and Drug
Administration approval of its New Drug Application for the Company's novel
combination product, Zylet® (loteprednol etabonate 0.5% and tobramycin
0.3% ophthalmic suspension). Zylet is indicated for the
treatment of steroid-responsive inflammatory ocular conditions for which a
corticosteroid is indicated and where superficial bacterial ocular infection or
a risk of infection exists.
The prescription eye drop will be available in the United States early in the first quarter of 2005 in three sizes, 2.5 mL, 5 mL and 10 mL.
The corticosteroid component of Zylet is loteprednol etabonate, Bausch & Lomb's proven, patented, site-specific steroid, which, for the first time, is combined with the time-tested efficacy of tobramycin to be the first novel ophthalmic corticosteroid/antibiotic combination approved by FDA in more than 15 years.
"Bausch & Lomb's proprietary Zylet product will provide a welcome alternative for eye care professionals who want to prescribe a combination drug with both power and protection for a wide range of patients including steroid responders, ocular hypertensives and those with glaucoma," said Gary M. Phillips, M.D., Bausch & Lomb vice president - Global Pharmaceuticals. "We are looking forward to introducing this new drug combination into the nearly $200 million ophthalmic combination U.S. market in which more than four million prescriptions were written in the last 12 months."
Bausch & Lomb will manufacture the Zylet product at its pharmaceuticals manufacturing facility in Tampa, Fla.
Bausch & Lomb is the eye health company, dedicated to perfecting vision and enhancing life for consumers around the world. Its core businesses include soft and rigid gas permeable contact lenses and lens care products, and ophthalmic surgical and pharmaceutical products. The Bausch & Lomb name is one of the best known and most respected healthcare brands in the world. Founded in 1853, the Company is headquartered in Rochester, New York. Bausch & Lomb's 2004 revenues were $2.2 billion; it employs approximately 12,400 people worldwide and its products are available in more than 100 countries. More information about the Company can be found on the Bausch & Lomb Web site at www.bausch.com . Copyright Bausch & Lomb Incorporated.
® / TM denote trademarks of Bausch & Lomb Incorporated.
