Bausch & Lomb Zylet approved

Executive Summary

Bausch & Lomb's combination ophthalmic Zylet clears FDA Dec. 14 for treatment of "steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists." B&L will launch Zylet (loteprednol 0.5%/tobramycin 0.3%) in the first quarter of 2005. The product will be promoted by reps who had been detailing Optivar, which is being taken in-house by MedPointe. B&L will conduct a Phase IV study of Zylet in 60 children up to six years of age. Loteprednol developer Pharmos expects to receive a milestone payment from B&L in the next six months...