Eye therapy, glaucoma products receive approvable letters

Rochester, NY-The FDA has issued approvable letters to Bausch & Lomb for loteprednol etabonate and tobramycin ophthalmic suspension (ZyLET), and Allergan Inc. for its bimatoprost 0.03%/timolol 0.05% solution (Lumigan).

The approvable letters outline the parameters the companies must meet to obtain final marketing approval.

Bausch & Lomb's product is a combination therapy for patients with steroid-responsive inflammatory ocular conditions who have or are at risk of developing superficial bacterial ocular infections.

Allergan's product is a treatment for glaucoma. The company said the FDA's letter indicated the need for additional clinical investigation. That study is expected to conclude by the end of 2004.