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Michael Burr, Sarah Molokhia, Arturo Chayet, Balamurali Ambati; Safety of IVMED-10 & IVMED-20 in a Pilot Clinical Trial for Post-Cataract Inflammation. Invest. Ophthalmol. Vis. Sci. 2019;60(9):3374.
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IVMED-10 & IVMED-20 were assessed for safety in a pilot clinical trial. We hypothesize that IVMED-10 will treat pain and inflammation in routine cataract extraction and that IVMED-20, in addition to treating pain and inflammation from the surgery, will prevent clinically meaningful retinal thickening in patients with diabetes, epiretinal membranes, and retinal vein occlusions, among other known risk factors for cystoid macular edema (CME) development.
This is an open-label, non-controlled, single center study. Volunteer patients in need of cataract extraction that met the eligibility criteria were admitted to the study. This study reports on 20 patients (cohort #1: 8 IVMED-10 & cohort #2: 12 IVMED-20). Best corrected visual acuity (BCVA), intraocular pressure (IOP), summed ocular inflammation score (SOIS), and ocular coherence tomography (OCT; only pre-op and weeks 5 & 12) of central retinal thickness were measured prior to surgery, day 1, and weeks 1 & 5. Outcomes of IVMED-20 was also measured at week 12.
IVMED-10 & IVMMED-20 are bioerodible dexamethasone releasing implants intended for intracapsular placement during cataract surgery. IVMED-10 is intended to replace anti-inflammatory eye drops for routine cataract extractions. IVMED-20 is similar to IVMED-10, but only intended for patients that have known risk factors for CME. Treatment eyes were very quiet where BCVA, IOP, and SOIS were consistent with published standard of care (SOC) outcomes. IVMED-20 patients showed a decrease in CRT from published SOC outcomes while IVMED-10 patients showed comparable thicknesses to reported SOC outcomes. All adverse events were transient in nature.
IVMED-10 & IVMED-20, in routine surgeries and cases with high risk of CME development respectively, warrant further investigation as an alternative to anti-inflammatory eye drops prescribed after cataract extraction. These proof of concept data sets, albeit not statistically powered, suggest the ability to safely control inflammation without anti-inflammatory eye drops. Additionality, both products demonstrated the ability to control retinal thickness similar to or better than published CRT outcomes with standard of care (steroid and NSAID). Reducing retinal thicknesses in high risk patients has the potential to significantly lower CME occurrence.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.
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