iVeena Completes Phase I/IIa Study of IVMED-10 for Post-Cataract Inflammation

November 17, 2017: By Jon Swedien

iVeenaiVeena Delivery Systems has successfully completed a pilot clinical trial for its lead product, IVMED-10, a bioerodible implant that treats pain and inflammation after cataract surgery, the Salt Lake City-based company announced Nov. 8.

IVMED-10 is a sustained release implant, based on the company’s intracapsular drug delivery platform, that delivers dexamethasone for two weeks. The device is placed in the lens capsule during the time of cataract surgery. It is intended for patients undergoing routine cataract extraction, iVeena said.

Eight patients were enrolled in the Phase I/IIa, single-site, single-arm, open-label clinical study. iVeena said an independent clinical trial report found IVMED-10 was safe and effective for the control of inflammation typically observed following cataract surgery. Retinal thickness outcomes were comparable to published data of nonsteroidal anti-inflammatory drugs and steroid standard of care therapy. All adverse events, including elevated intraocular pressure, corneal edema, and pain, were transient in nature. All patients had 20/25 best-corrected visual acuity or better at the end of the study, iVeena said.

iVeena has additional clinical studies of IVMED-10 planned for Q1-2018.

The company is also developing IVMED-20, a sustained release implant that delivers dexamethasone for six weeks. The product is placed in the lens capsule at the time of cataract surgery and is intended for patients that are at risk of developing retinal thickening in association with cataract extraction.

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