OXIGENE ANNOUNCES POSITIVE DATA FOR MACULAR DEGENERATION DRUG

OXiGENE has announced positive results from its Phase II combretastatin A4 phosphate (CA4P) clinical trial in myopic macular degeneration. The primary efficacy endpoint of the study was maintenance of visual acuity (defined as less than a three line loss in visual acuity at three months), and 100 percent of the patients met this endpoint. Safety results were favorable and in line with expectations, with no drug-related serious adverse events being reported.

The company also said it has completed a pre-investigational new drug application meeting with the FDA regarding two topical ophthalmic formulations (eye drops and ocular mini-tabs) for CA4P in the treatment of age-related macular degeneration and intends to proceed with further development of topical formulations.

The double-blind, dose-ranging, multicenter study was designed to evaluate the safety and efficacy of intravenous CA4P for treating subfoveal choroidal neovascularization in subjects with pathologic myopia. Subjects were assigned to receive CA4P at doses of 27, 36 or 45 mg/m2. A total of 23 subjects were enrolled. Subjects received two doses of CA4P one week apart with up to three additional doses and they were followed for three months for efficacy and safety.

Secondary variables included fluorescein angiography and optical coherence tomography. Safety was assessed via vital signs, laboratory tests, slit-lamp biomicroscopy, dilated fundus examination, fundus photography, serial electrocardiograms and elicited and observed adverse events.