Phase III results on pegaptanib sodium

Results from a Phase III study showed that pegaptanib sodium significantly improved the vision in patients with diabetic macular oedema (DME).

In the study of 260 patients with DME, 37% of patients treated with pegaptanib sodium gained two lines, or 10 letters, of vision on the ETDRS eye chart at 54 weeks, compared with 20% of patients who received a sham procedure which consisted of anaesthesia and a simulated injection in the eye. Pfizer plans to submit to the EMEA a variation of the European Marketing Authorization for MACUGEN (pegaptanib sodium) to include an indication for DME.