SAN DIEGO — Repeat injections of dexamethasone intravitreal implant have no cumulative effect on IOP, and the rate of high IOP spikes is low, according to a speaker here.
The MEAD study, which was the basis for the recent U.S. Food and Drug Administration approval of Ozurdex (dexamethasone intravitreal implant, Allergan) for treatment of diabetic macular edema (DME) in patients who are pseudophakic or scheduled for cataract surgery, also demonstrated the adverse effect of increased IOP in 36% of treated patients.
“Increased IOP was a common side effect of dexamethasone implant for DME, but it was easily managed with intraocular pressure medications,” Michael A. Singer, MD, said at the American Society of Retina Specialists annual meeting.
The rate of concerning IOP spikes, those of 35 mm Hg or more, is only about 2%, Singer said.
Furthermore, it is unlikely that a spike would occur after the third injection if none occurred with the first two, he said.
“What’s important to note, when you give more Ozurdex, you don’t get more spikes. It’s not a cumulative effect over time,” Singer said.
The MEAD study included 1,048 patients with DME who could be re-treated no more frequently than every 6 months. Despite the occurrence of increases in IOP, the dexamethasone implant still demonstrated benefit, Singer said. IOP returned to the normal range by 6 months after each injection.
Singer is a consultant to Allergan.