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FDA approves Iluvien for treatment of DME
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The U.S. Food and Drug Administration has approved Iluvien for the treatment of diabetic macular edema in patients previously treated with corticosteroids who did not have a significant increase in IOP, Alimera Sciences announced in a press release.
Iluvien (fluocinolone acetonide implant 0.19 mg) was approved with no requirement that patients undergo cataract surgery, according to the release.
Pravin U. Dugel
The FDA approval was based on clinical trial data showing that by 24 months after implantation, 28.7% of patients had a 15-letter or greater improvement in best corrected visual acuity. Patients who received the implant had a significantly greater improvement in BCVA than control patients from 3 weeks to 36 months, according to the release.
“The approval of Iluvien is wonderful news for the retinal community, as recent studies have indicated that as many as 50% of DME patients are not optimally managed with today’s standard of care known as anti-VEGF therapies,” Pravin U. Dugel, MD, an Alimera consultant and OSN Retina/Vitreous board member, said in the release. “Having a multi-year delivery, low-dose corticosteroid drug will provide an additional treatment option for patients with this disease.”
Alimera expects to begin selling Iluvien in the U.S. during the first quarter of 2015, the release said.
The company is scheduled to hold a conference call detailing the approval at 8:30 a.m. Eastern Time on Wednesday, Oct. 1.
To participate in the event, call 877-369-6586 in the U.S. and Canada or 253-237-1165 internationally. A live webcast will be accessible on the Investor Relations section of the company website at www.alimerasciences.com.