Ophthalmic suspension drug earns approvable letter from FDA

September 10, 2004

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).

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.