Omidenepag isopropyl non-inferior to timolol for OAG/OHT
Omidenepag isopropyl (OMDI) 0.002% was found to be non-inferior to timolol 0.5% in reducing intraocular pressure (IOP) in adults with open-angle glaucoma (OAG) or ocular hypertension (OHT), according to a presentation at AAO 2021.
OMDI is currently marketed in regions in Asia under the brand name Eybelis. Reviews by regulatory agencies in the United States are currently pending.
In this randomized phase 3 trial, the efficacy of OMDI 0.002% once daily in reducing IOP in patients with OAG or OHT after 3 months of treatment was compared to timolol maleate 0.5% twice daily. Adults with OAG or OHT in both eyes, or one eye with OAG and the other with OHT with a baseline of IOP ≥22 mmHG in ≥1 eye and ≤34 mmHG in both eyes, were included.
On day 1, week 1, week 6, and month 3 IOP was measured at 8AM, 10AM, and 4PM.
OMDI was found to be non-inferior to Timolol at all timepoints with no significant difference between each group in response rates at week 1, week 6, and month 3.
“I think as a clinician it is very exciting to have a potential drop that’s once a day that really improves compliance, is effective, which is most important…” said presented Michelle R. Butler, MD during the Industry Showcase presented by Santen, Inc.
Most adverse events were mild with conjunctival hyperemia being the most common, which Dr Butler said was not surprising.
Omidenepag Isopropyl 0.002% QD vs. Timolol Maleate BID for Open-Angle Glaucoma/Ocular Hypertension: SPECTRUM 4. Presented at: AAO 2021.