InSite Vision Inc.'s sustained-release formulation of pilocarpine fortreating glaucoma, PilaSite, showed the same decrease in intraocularpressure (IOP) as pilocarpine and had reduced adverse reactions.The Alameda, Calif. company reported those final results Friday fromthe first of its pivotal Phase III trials at the annual meeting of TheAssociation for Research Vision and Ophthalmology in Sarasota, Fla.A second pivotal Phase III began in February, and assuming positiveresults, InSite expects to file an new drug application for PilaSite in1995, said Kumar Chandrasekaran, InSite's chairman and CEO.A total of 203 patients were enrolled in the first study, 100 of whomreceived 2 percent PilaSite eyedrops twice per day, and 103 whoreceived conventional 2 percent pilocarpine eyedrops four times perday. About half of the patients had open-angle glaucoma and half hadocular hypertension.Both groups showed average IOP decreases of 20 percent, and only 12of the PilaSite patients terminated their treatment, as compared to 21from the pilocarpine group, Carol DeGuzman, InSite's senior directorof corporate communications, told BioWorld.InSite has incorporated the drug into its DuraSite delivery system,which gradually release pilocarpine into the eye over several hours.DeGuzman said the company believes cutting the doses in half with thesustained-release delivery system will reduce side effects such as browache and short-term vision problems, and encourage patientcompliance. _ Jim Shrine
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