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Triamcinolone implant for diabetic macular edema well tolerated at 9 months

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The I-vation intravitreal implant was well tolerated in patients with diabetic macular edema at 9 months' follow-up, according to results from a phase 1 study of the device.

The study is evaluating the safety and tolerability of the I-vation device (SurModics) in 31 patients with diabetic macular edema. The device is designed to deliver a sustained release of triamcinolone acetonide, and investigators are testing a slow-release formulation that delivers 1 µg/day and a fast-release formulation that delivers 3 µg/day.

At 9 months' follow-up, both doses were well tolerated. Investigators observed no serious adverse events or sustained IOP increases above 22 mm Hg. In addition, 33.33% of patients had best corrected visual acuity of 20/40 or better compared with 18% at baseline, according to the study, presented as a poster at the Association for Research in Vision and Ophthalmology meeting.

Macular thickness and fluorescein leakage also improved or remained stable in all patients, the authors noted.

Twelve month results are expected later this summer and a phase 2 trial is planned, said John Saharek, director of commercial development for ophthalmology at SurModics.