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ARTICLE | Clinical News

Vitrase enzyme injection: Phase III

June 29, 1998 7:00 AM UTC

Advanced Corneal presented final data from its 225-patient Phase III dose response trial of Vitrase in Mexico. Patients experiencing vitreous hemorrhage for a minimum of one month received a single injection of 7.5, 37.5 or 75 IU of Vitrase and were followed for up to 8 weeks. Of 204 evaluable patients, 163 had prospectively defined dense hemorrhage. The highest proportion of clearing, 62.7 percent, was seen in the dense hemorrhage subset of the 75 IU dose group (p=0.027). No dose response was seen with mild to moderate hemorrhage. No serious adverse events were reported at any dose.

The company also presented interim data from a 153-patient U.S. Phase II dose response study with the same design. The highest rate of clearing was again seen in the dense hemmorhage subset of the 75 IU group. Hemorrhage cleared in 60 percent of patients in that group, with a mean time to clearance of 32 days. The data were presented at the International Congress of Ophthalmology in Amsterdam. ...