Pharmos Corp. won FDA approval for two ophthalmic drugs — one for inflammation and one for allergic conjunctivitis — and intends to launch the products in a month or two, said Gad Riesenfeld, president and chief operating officer of the Iselin, N.J.-based company.

"I would say the minimum is four to six weeks," Riesenfeld said. "That is the plan."

Lotemax, a topical 5 percent suspension solution of loteprednol etabonate, was approved for steroid-responsive inflammatory conditions and, in a separate new drug application, for post-operative inflammation. Pharmos received an approvable letter for Lotemax from the FDA last fall. (See BioWorld Today, Sept. 16, 1997, p. 2.)

The other product, Alrex, is a 2 percent suspension of the same compound, and was approved for temporary relief of allergic conjunctivitis.

"We have two products approved, but it's composed of three new NDAs [new drug applications]," Riesenfeld said.

Lotemax will be used for a variety of site-specific inflammatory conditions. "It has a broader approval than any other steroid," he said.

Cost had not been precisely established, Riesenfeld said.

The two drugs are the first to emerge from a three-year partnership between Pharmos and Bausch & Lomb Pharmaceuticals Inc., the Tampa, Fla.-based subsidiary of Bausch & Lomb Inc., of Rochester, N.Y., which was granted worldwide manufacturing and marketing rights in the deal.

A third product, which combines loteprednol etabonate with an anti-infective, remains under development by the companies. — Randall Osborne