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Zylet

Generic name: loteprednol and tobramycin
Treatment for: Uveitis, Iritis, Conjunctivitis, Bacterial, Keratitis, Cyclitis

FDA Issues Approvable Letter to Bausch & Lomb for Ophthalmic Anti-inflammatory/Antibiotic Combination Product

ISELIN, N.J., August 09, 2004 -- Pharmos Corporation (NASDAQ:PARS) former marketing partner, Bausch & Lomb, has received from the U.S. Food and Drug Agency (FDA) an approvable letter for ZyLET, the NDA for which was filed by Bausch & Lomb last year. The first disclosure of this event was made by Bausch & Lomb in a Form 10Q filed on August 3, 2004, in which Bausch & Lomb also indicates it continues to target approval of ZyLET in the second half of 2004. Details of the approvable letter have not been publicly disclosed by Bausch & Lomb.

In 2001, Bausch & Lomb acquired the rights to the loteprednol etabonate ophthalmic business of Pharmos Corporation. Bausch & Lomb will pay Pharmos a milestone payment upon approval to market the product.

ZyLET is a loteprednol etabonate and tobramycin ophthalmic suspension. 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.

Pharmos discovers, develops, and commercializes novel therapeutics to treat a range of indications, in particular neurological and inflammation- based disorders. The Company's first neuroprotective product is dexanabinol, a tricyclic dextrocannabinoid, currently undergoing clinical testing as a treatment for TBI and as a preventive agent against post-surgical cognitive impairment. Other dextrocannabinoid compounds and CB2-selective receptor agonist compounds from Pharmos' proprietary synthetic cannabinoid library are being studied in pre-clinical programs targeting stroke, pain, multiple sclerosis and other disorders.

Posted: August 2004

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