This article is part of Ophthalmology Advisor’s conference coverage from the 2021 meeting of the American Academy of Ophthalmology, held in New Orleans from November 12 to 15, 2021. The team at Ophthalmology Advisor will be reporting on a variety of the research presented by the ophthalmology experts at the AAO. Check back for more from the AAO 2021 Meeting.
A phase 3 study of 0.002% omidenepag isopropyl (OMDI) shows noninferiority to 0.5% timolol maleate in patients with primary open-angle glaucoma and ocular hypertension, according to a presentation at the AAO. OMDI was approved for the management of intraocular pressure (IOP) in patients with glaucoma and ocular hypertension in Japan in 2018. Researchers found that the 0.002% OMDI drop can be dosed at a single drop a day and achieve result noninferior to 0.5% timolol maleate dosed twice a day.
The researchers monitored 409 patients with open-angle glaucoma/ocular hypertension for 3 months. The OMDI treatment was used to manage 204 patients, while 205 were managed with timolol. The primary efficacy endpoint was IOP measured at 8:00, 10:00, and 16:00 at weeks 1, 6, and at month 3. Researchers defined noninferiority as the upper limit of the 95% confidence interval of the mean difference in IOP (OMDI minus timolol), and IOP difference of 1.5 mm Hg or less at all 9 time points, and an IOP difference of 1.0 mm Hg or less at 5 or more time points.
The results showed that the patients treated with OMDI had a mean difference in IOP of 1.5 mm Hg or less at all 9 time points, and of 1.0 mm Hg or less at 6 time points.
Investigators did note some adverse events reported for both medications; 41.2% in the OMDI group, and 32.7% in the timolol group, for rates of 31.9% and 22.0%, respectively. Macular edema occurred in 2 patients, but was resolved in both cases.
Wirta D, Lu H, Bacharach J. Omidenepag isopropyl vs timolol maleate for OAG/OHT: the phase 3 spectrum 4 trial. Poster presented at: The American Academy of Ophthalmology 2021 Annual Meeting; November 12-15, 2021; New Orleans. Abstract PO215.