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Specialist clarifies criteria for choosing between approved sustained-release steroid implants

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NICE, France — Sustained-release steroid implants are a successful strategy to use in well-selected patients with diabetic macular edema, taking into account potential complications. Regulatory approval by the European Medicines Agency and the FDA has clarified indications, Anat Loewenstein, MD, said at the Euretina meeting.

Both Iluvien (fluocinolone acetonide intravitreal implant 0.19 mg, Alimera Sciences) and Ozurdex (dexamethasone intravitreal implant 0.7 mg, Allergan) have proved successful in targeting the inflammatory pathway and effective in improving vision for a long period, Loewenstein said.

Anat Loewenstein

Iluvien has a longer span of action, up to 36 months, and greater efficacy in chronic DME cases. Ozurdex has a shorter action of 4 to 5 months but a lower rate of complications in terms of cataract formation.

“In phakic eyes, studies have shown that 60% of Ozurdex-treated eyes vs. 80% of Iluvien-treated eyes develop cataract,” Loewenstein said.

An increase in IOP was shown by studies to occur in 42% of dexamethasone-implanted eyes and 38% of fluocinolone-implanted eyes and was treated in most cases with medications.

“Less than 1% of eyes with dexamethasone and 5% of eyes with fluocinolone required a filtering procedure,” Loewenstein said.

Taking into account the results of the studies and the official indications of the EMEA and FDA, she defined the patient for Iluvien as “a chronic patient with ME since more than 3 years, insufficiently responsive to other available therapies, including Ozurdex.” Another type of eligible patient is “a patient with compliance issues, such as difficulties to attend frequent hospital visits.”

Ozurdex, on the other hand, is best indicated for patients unsuitable for or insufficiently responsive to anti-VEGF therapy.

“In both cases, there are advantages if the patient is pseudophakic,” Loewenstein said. – by Michela Cimberle

Disclosure: Loewenstein reports she is a consultant to Allergan, Alcon, Bayer, Notal Vision, Novartis and Teva.