Pharmos Corp. said preliminary results of a Phase III study revealedthat its lead product, Lotemax, demonstrated "significant efficacy" inthe treatment of uveitis, which is inflammation of the middle tunic ofthe eye.
Harry Dachowitz, Pharmos' chief financial officer, said the study isthe fourth Phase III trial in which Lotemax, the brand name ofloteprednol etabonate, has shown success in treating ophthalmicinflammations. Two clinical trials involved tests of the drug for giantpapillary conjunctivitis and a third focused on seasonal allergicconjunctivitis.
"Giant papillary and seasonal allergic conjunctivitis are externalinflammations," Dachowitz said. "Uveitis is an internalinflammation. The FDA requested that we conduct the uveitis studyto get class labeling for Lotemax."
In addition to showing efficacy, Pharmos' investigators said theuveitis studies showed the drug "causes significantly less elevationof intraocular pressure than currently available ophthalmic steroids."
Pharmos said its expects to submit a new drug application to theFDA for Lotemax in January. The company's stock(NASDAQ:PARS) closed Monday at $1.31, up 3 cents.
Last month, Pharmos cut its staff by 20 percent and said it wasmoving its New York headquarters south to consolidate those officeswith its research facilities in Alachua, Fla., in an effort to reduceexpenses and focus its resources on development of Lotemax. _Charles Craig
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