FDA OKs Implant (Ozurdex) for Some With Diabetic Macular Edema

Miriam E. Tucker

Disclosures

June 30, 2014

The US Food and Drug Administration has approved Allergan's Ozurdex (dexamethasone intravitreal implant) 0.7 mg for use in adult patients with diabetic macular edema who have had an artificial lens implant or are scheduled for cataract surgery.

Ozurdex is a sustained-release biodegradable steroid implant that uses a solid polymer to suppress the inflammation that causes diabetic macular edema by releasing the steroid over an extended period. It has demonstrated long-term efficacy without the need for monthly injections, according to an Allergan statement.

The implant is already available for the treatment of macular edema after branch retinal vein occlusion or central retinal vein occlusion and for the treatment of noninfectious uveitis affecting the posterior segment of the eye.

The new indication is: "To treat adults with diabetic macular edema who have an artificial lens implant (pseudophakic) or who are scheduled for cataract surgery (phakic)."

Approval for the new indication was based on 2 multicenter, 3-year randomized, sham-controlled, masked clinical trials in which the implant increased the proportion of patients with a 15-letter or more improvement in best-corrected visual acuity from baseline.

The most common adverse events in the studies included cataracts and elevated intraocular pressure. An increase in mean intraocular pressure was seen with each treatment cycle; mean pressure generally returned to baseline between treatment cycles.

Other adverse effects among patients with diabetic macular edema included conjunctival blood spot, reduced vision, conjunctival swelling and/or inflammation, floaters, dry eye, vitreous detachment, vitreous opacities, retinal aneurysm, foreign body sensation, corneal erosion, inflammation of the cornea, anterior chamber inflammation, retinal tear, drooping eyelid, and high blood pressure.

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