SALT LAKE CITY--(BUSINESS WIRE)--iVeena Delivery Systems (iVeena), a biopharmaceutical company that develops innovative ophthalmology products, today announced the successful completion of a pilot clinical trial for its lead product IVMED-10, a bioerodible implant that treats pain and inflammation after cataract surgery based on its intracapsular drug delivery platform. IVMED-10 controls the release of dexamethasone for two weeks from the lens capsule and is placed during cataract surgery.
A total of eight patients were enrolled in the Phase 1/2a, single site, single arm, open label clinical study. An independent clinical trial report indicates that IVMED-10 was safe and effective for the control of inflammation typically observed following cataract surgery. Retinal thickness outcomes are comparable to published data of NSAID and steroid standard of care therapy. All adverse events, including elevated IOP, corneal edema and pain were transient in nature. All patients had 20/25 BCVA or better at the end of the study.
“The results of the study are very encouraging,” said Jerry Simmons, CEO of iVeena. “This study was designed to measure the safety of IVMED-10 and it met the primary objectives. These results support the ongoing clinical development of IVMED-10 and warrant further investigation into the intracapsular platform.” iVeena has additional clinical studies of IVMED-10 and initial studies of IVMED-20 planned for Q1 2018.
About IVMED-10 & IVMED-20
IVMED-10 is a sustained release implant that delivers dexamethasone for two weeks that is placed in the lens capsule during the time of cataract surgery. It is intended for patients undergoing routine cataract extraction. IVMED-20 is 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.
About iVeena Delivery Systems, Inc.
iVeena Delivery Systems, Inc. (iVeena) is a privately held biopharmaceutical company that develops innovative ophthalmology products. iVeena utilizes a proprietary intracapsular drug delivery platform to enhance a medication’s ocular bioavailability to anterior and posterior eye segments. The lead product delivers dexamethasone to treat post-cataract pain and inflammation as well as enable the prevention of retinal thickening associated with cataract extraction. The Company was formed to commercialize technology from the Moran Eye Center at the University of Utah. The Company is structured to develop product candidates through clinical trials and then out-license to pharmaceutical marketing partners. Currently, iVeena has completed a pilot clinical trial of its lead product (IVMED-10) and is preparing two additional products for clinical trials in Q1 2018 including keratoconus (IVMED-80) and prophylaxis of retinal thickening associated with cataract extraction (IVMED-20).