Loteprednol .5% And .2% Solutions Clear FDA: Bausch & Lomb To Market

Bausch & Lomb's Lotemax (loteprednol) will be available in four to six weeks, carrying "the broadest range of indications of any ophthalmic steroid on the market," including post-operative inflammation, the company said.

The solution was approved March 9 for treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the eye. Lotemax also received an indication under a separate NDA for treatment of post-operative inflammation following ocular surgery. The price is described as comparable to other marketed ophthalmic steroids.

FDA also approved Bausch & Lomb's lower-strength formulation of loteprednol, Alrex, for temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.

Lotemax (loteprednol .5% ophthalmic suspension) and Alrex (loteprednol .2% ophthalmic suspension) were co-developed by Bausch & Lomb and Iselin, New Jersey-based Pharmos. Bausch & Lomb received the rights to manufacture and market the ophthalmic pharmaceutical line in June 1995.

The agreement was expanded to include international markets, including Europe and Canada, in December 1996. Pharmos will receive royalties on sales at a rate of 29% in the U.S. and 24% elsewhere.

Lotemax and Alrex are the first products developed by Pharmos to be approved. Bausch & Lomb will market the products on an exclusive basis in the U.S.

Bausch & Lomb estimated the ophthalmic anti-inflammatory market in the U.S. has a value of about $95 mil.

The ophthalmic anti-allergy market is similarly valued at around $100 mil., the company observed.

Bausch & Lomb noted that sales teams recently added through the acquisitions of Chiron Vision and Storz Instrument Company from American Home Products have well-established relationships with the ophthalmologic community and will promote the new drugs to ophthalmic surgeons.

The two acquisitions, completed in December 1997, make up Bausch & Lomb's new surgical business unit ("The Pink Sheet" Oct. 27, 1997, T&G-10).

Loteprednol's chemical structure allows it to be predictably transformed by enzymes in the eye to an inactive metabolite, increasing its safety profile, the companies claimed.

"The excellent safety profile of Lotemax was demonstrated in clinical trials by a low incidence of increased ocular pressure, a significant side effect of ophthalmic steroid use," the companies said.

None of the products currently on the market carries a specific indication for treatment of post-operative inflammation.

The co-development partners also have a combination loteprednol/tobramycin product ready to begin Phase III trials for treatment of post-operative inflammation following ocular surgery with risk of infection.

Lotemax NDA 20-583 was originally submitted March 29, 1995 and was reviewed as a "1S" application, indicating a standard review for a new molecular entity. The application was deemed "not approvable" April 10, 1996 and "approvable" Sept. 3, 1997 ("The Pink Sheet" Sept. 22, 1997, In Brief). The user fee goal date was June 12.

The post-operative inflammation NDA (20-841) was submitted March 7, 1997 and had a user fee goal date on March 10. It also received a "1S" review.

The Alrex NDA (20-803), submitted Jan. 31, 1997, was reviewed as a "3S" application, designating a standard review for a new formulation of a product. It was approved ahead of schedule with a user fee goal date of May 3.

As a Phase IV commitment for Alrex, Bausch & Lomb agreed to do additional stability testing and to withdraw from the market any loteprednol product in which the pH falls below a certain level.

Bausch & Lomb also markets Crolom (cromolyn) for keratoconjunctivitis, vernal conjunctivitis and vernal keratitis; the ocular beta blocker Optipranalol (metipranolol); and ophthalmic antibiotic formulations.