Zylet, which was approved for marketing by the FDA on December 15, is part of the loteprednol etabonate business that Pharmos sold to Bausch & Lomb in 2001.
Pharmos also noted that an additional milestone payment could be earned based on Bausch & Lomb sales of Zylet over the next two years. The maximum future payment is $10 million.
Zylet is a combination anti-inflammatory and antibiotic (0.5% loteprednol etabonate and 0.3% tobramycin) to treat steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of infection exists.
Zylet is the third product containing loteprednol etabonate approved by the FDA. Lotemax and Alrex have been marketed since 1998 as a result of three previous new drug application (NDA) approvals. Zylet represents the final product resulting from Pharmos’ earlier collaboration with Bausch & Lomb.