Pegaptanib sodium data promising for DME, other retinal vascular diseases

October 15, 2005

The preliminary pegaptanib sodium (Macugen, OSI/Eyetech Pharmaceuticals) exploratory phase II data indicate that the drug seems to be successful for treating diabetic macular edema (DME), according to Steven Schwartz, MD, who reported the findings of the Macugen Diabetic Retinopathy Study Group during the retina subspecialty day at the American Academy of Ophthalmology annual meeting.

Chicago-The preliminary pegaptanib sodium (Macugen, OSI/Eyetech Pharmaceuticals) exploratory phase II data indicate that the drug seems to be successful for treating diabetic macular edema (DME), according to Steven Schwartz, MD, who reported the findings of the Macugen Diabetic Retinopathy Study Group during the retina subspecialty day at the American Academy of Ophthalmology annual meeting.

“There is a large body of basic science evidence suggesting that the level of vascular endothelial growth factor (VEGF) 165 is elevated in experimental diabetes and in the human condition,” Dr. Schwartz explained.

In an international multicenter, randomized, masked, 36-week trial, patients were included who had diffuse DME of greater than one half of a disc area in the foveal center and best-corrected visual acuity between 20/50 and 20/320 in the affected eye and 20/100 or better in the fellow eye. Patients were randomized to injections of sham treatment (n = 42) or 0.3 mg (n = 44), 1 mg (n = 44), or 3 mg of pegaptanib sodium) for from 12 to 30 weeks, he explained. Dr. Schwartz is chief of the Retina Division, Jules Stein Eye Institute/David Geffen School of Medicine at University of California Los Angeles.

More than 90% of patients in each group completed the study. All patients but three received more than three injections.

Dr. Schwartz focused on the data from the group that received the 0.3-mg dose group because of its efficacy.

“There was a shift toward better vision in the patients who received the 0.3-mg dose compared with the sham treatment group. There was a clinically and statistically significant increase in the visual acuity in the treated eyes compared with the sham-treated eyes,” he said.

“There was also an absolute change in retinal thickness in the treated eyes that showed a mean decrease of 68 µm compared with an increase of 4 µm in the sham-treated group. Only 25% of eyes in the treated group needed panretinal photocoagulation at 12 weeks compared with 50% of eyes in the sham-treatment group,” he reported.

The visual acuity improvement persisted for 1 year after the last injection of pegaptanib sodium.

Pegaptanib sodium may also be a useful therapy other retinal vascular disease: telangiectasia, familial exudative vitreoretinopathy, retinopathy of prematurity, and venous occlusions.