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FDA approves implant for macular edema associated with RVO

Irvine, CA—The FDA has approved dexamethasone intravitreal implant 0.7 mg (Ozurdex, Allergan) for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). It is the first drug approved for this indication and represents the manufacturer’s entry into the retina market, according to the company.

In an in-office procedure, the corticosteroid implant is placed in the vitreous cavity via a proprietary solid polymer delivery system (Novadur, Allergan), which enables the extended release of the drug. The treatment is expected to be available in the third quarter of this year.

The efficacy of the implant was assessed in two multicenter, double-masked, randomized parallel studies involving approximately 1,300 patients. In each individual study and in a pooled analysis, time to achieve a ≥15-letter (three-line) improvement in best-corrected visual acuity (BCVA) cumulative response rate curves was significantly faster with the implant compared with sham (p <0.01).

“In the clinical studies, 20% to 30% of patients suffering from this severe retinal condition experienced a three-line improvement in BCVA, with an onset of effect within the first 2 months following therapy,” said Scott Whitcup, MD, executive vice president, research and development, and chief scientific officer, Allergan.

The duration of effect persisted approximately 1 to 3 months after onset.

“This new therapy provides physicians with a meaningful advancement in treating RVO, offering a convenient option to patients through its unique extended delivery profile,” said Mark S. Blumenkranz, MD, professor and chairman, Department of Ophthalmology, Stanford University, Palo Alto, CA.