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New Orleans-A biodegradable implant containing dexamethasone (Posurdex, Allergan) showed significant improvements in best-corrected visual acuity at a dose of 700 micrograms compared with 350 microns and observation, reported Julie Haller, MD, at the annual meeting of the American Academy of Ophthalmology.
Three hundred six patients with persistent macular edema were randomized to either 350 micrograms (n = 100), 700 micrograms (101), or observation (n = 105). Most of the study patients had either diabetic retinopathy (n = 165) or central or branch retinal vein occlusion (n = 102). The device was surgically implanted into a sclerectomy.
Dr. Haller from Baltimore reported that at 90 days after implantation the 700-microgram dose outperformed the lower dose and observation in the degree of increased visual acuity, decreased retinal thickness, and decreased leakage. The IOP increased in 17% of the eyes that received the 700-microgram dose and in 12% of the eyes that received the 35-microgram dose, but later decreased. There was no increase in the progression of cataract in any eyes.
"The implant achieved the primary efficacy outcome with the 700-microgram dose in that there was a significant greater than 3 line improvement in vision 180 days after implantation. There was a clear dose-related response, and there were no safety issues associated with the implant," Dr. Haller said.
The phase III trial is starting. In this phase, the device will be implanted into the vitreous base using an applicator.