iVeena Completes Phase I/2a Pilot Clinical Study of IVMED-10, a Bioerodable, Sustained Release, Intracapsular Implant to Treat Inflammation and Pain Associated with Cataract Surgery

28 October 2017

iVeena Completes Phase 1/2a Pilot Clinical Study for IVMED-10, a Bioerodable, Sustained Release, Intracapsular Implant that Delivers Dexamethasone to Both Anterior and Posterior Eye Segments to Treat Inflammation and Pain Associated with Cataract Surgery.

A total of eight patients were enrolled in the Phase 1/2a, single site, clinical study. Seven patients completed the study. An independent clinical trial report indicated 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.

iVeena has additional clinical studies of IVMED-10 and initial studies of IVMED-20 planned for 1Q 2018.

About IVMED-10 & IVMED-20
IVMED-10 is a sustained release implant that delivers dexamethasone for 2 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 6 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 complicated cataract extraction.