iVeena Delivery Systems announced the 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 2 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,” Jerry Simmons, CEO of iVeena, said in a company news release. “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.