Ophthalmic suspension drug earns approvable letter from FDA

The FDA issued an approvable letter to Bausch & Lomb in response to the new drug application the company filed in 2003 for its loteprednol etabonate and tobramycin ophthalmic suspension drug (Zylet).

Bausch & Lomb indicated that it still aims for approval of the ophthalmic suspension drug during the second half of this year.

The combination therapy is aimed at treating patients with steroid-responsive inflammatory ocular conditions who have or are at risk of developing superficial bacterial ocular infections.

Bausch & Lomb in 2001 acquired the rights to the loteprednol etabonate ophthalmic business of its former marketing partner, Pharmos Corp.

Bausch & Lomb will pay Pharmos a milestone payment to market the product upon its approval.