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PHARMOS COMPLETES INITIAL PHASE III TRIAL ON LOTEPREDNOL

 NEW YORK, Jan. 18 /PRNewswire/ -- Pharmos Corporation (NASDAQ: PARS) announced today that it has successfully completed a Food and Drug Administration (FDA) mandated Phase III clinical trial on more than 200 patients with Giant Papillary Conjunctivitis, the first of four pivotal Phase III clinical trials required for the New Drug Application (NDA) filing of Loteprednol Etabonate (Loteprednol).
 Since June 1993, Pharmos has enrolled more than 700 patients in over 40 sites in the United States in its Phase III clinical trial program, believed to be the largest Phase III evaluation of an ophthalmic steroid ever undertaken. Loteprednol is a novel, site-active steroid anti- inflammatory drug.
 A preliminary review of the patient Case Report Forms from this first Giant Papillary Conjunctivitis clinical trial suggests that Loteprednol is active, efficacious and safe. Pharmos anticipates that the second Giant Papillary Conjunctivitis study and the Seasonal Allergic Conjunctivitis clinical study, in which enrollment is complete with more than 280 patients, will also be completed shortly.
 Pharmos expects to complete the analysis of the two Giant Papillary Conjunctivitis clinical studies, as well as the clinical trial in Seasonal Allergic Conjunctivitis and in Uveitis so that the NDA of Loteprednol can be submitted in summer 1994.
 "This is an important milestone confirming Pharmos' commitment to build a line of novel ophthalmic drugs," said Haim Aviv, Chairman of Pharmos. The primary ophthalmic steroid market for Loteprednol exceeds $125 million annually worldwide, and the other indications for which Pharmos intends to develop Loteprednol exceed $500 million annually worldwide.
 "We believe the safety of Loteprednol distinguishes the product from all other ophthalmic steroids based on the demonstrated benefit of Pharmos' site-active technology," said Stephen R. Streber, President of Pharmos.
 Pharmos Corporation is engaged in the development of novel pharmaceuticals based on innovative drug delivery technologies targeting diseases of the eye, principally glaucoma and ocular inflammation, and the brain, principally stroke and head trauma.
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 /CONTACT: Henry M. Dachowitz, chief financial officer of Pharmos Corporation, 212-838-0087; Anthony J. Russo, Ph.D., of Noonan/Russo Communications, 212-696-4455 x202; or Donald C. Weinberger of Strategic Growth International, 212-826-9622/
 (PARS)


CO: Pharmos Corporation ST: New York IN: MTC SU:

LG-TW -- NY094 -- 2879 01/18/94 15:22 EST
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Publication:PR Newswire
Date:Jan 18, 1994
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