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    Dexamethasone implant shows good safety, visual outcomes in MEAD study

    The 3-year clinical trial served as basis for FDA approval of corticosteroid for DME

    Take-home

    Dexamethasone intravitreal implant 0.7 and 0.35 mg provided statistically and clinically significant improvement in best-corrected visual acuity and reduction in central subfield retinal thickness with an average of 4 to 5 injections over 3 years.

     

    Los Angeles—Inflammation is now considered a critical factor in diabetic retinopathy/diabetic macular edema (DME) pathogenesis,1 and steroids are well known for their ability to reduce edema quickly.

    As such, the Macular Edema: Assessment of Implantable Dexamethasone in Diabetes (MEAD) study served as the foundation for the FDA approval of dexamethasone intravitreal implant 0.7 mg (Ozurdex, Allergan) for the treatment of DME.2

    The MEAD study evaluated both the 0.7- and 0.35-mg versions in more than 1,000 patients over 3 years.

    “The mean number of injections was around 4 in each group over the course of the study,” said David S. Boyer, MD, clinical professor of ophthalmology, Department of Ophthalmology, University of Southern California Keck School of Medicine, Los Angeles.

    The dexamethasone intravitreal implantcan reduce the number of injections that patients need and the number of times they come into the office,” Dr. Boyer said. “We still have to be conscious of the fact they will need to come into the office for monitoring of their IOP.”

    People who come from a long distance for the injection may be able to have their IOP checked by their general ophthalmologist and treated closer to home, if necessary. It is hoped that this will decrease the treatment burden to patients and to the people who bring them to the office, he noted.

    In July 2014, the FDA approved the implant for the treatment of DME, but limited its use to pseudophakic patients or in phakic patients scheduled to undergo cataract surgery.

    “It’s going to be most useful in patients who don’t get the response we would like to see with anti-vascular endothelial growth factor (VEGF) therapies,” Dr. Boyer said. Since some patients do not respond well to anti-VEGF therapies, “most would be helped with a corticosteroid, since that’s a totally different mechanism of action.”

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