Results from the ORION-1 doublemasked, placebo-controlled, multiple-dose phase 2b trial have shown that 1% phentolamine mesylate ophthalmic solution (PMOS) can safely and effectively lower intraocular pressure (IOP) in glaucoma patients, and in parallel, modulate pupil diameter (PD) and improve visual acuity in refractive conditions such as presbyopia and dim light vision disturbances (DLD).
Glaucoma, presbyopia, and DLD are among the most common ocular disorders affecting aging populations.
Published in Clinical Ophthalmology (Auckland, New Zealand), researchers randomly assigned 39 patients with elevated IOP 1:1 to receive one evening dose of either 1% PMOS (19 patients) or placebo (20 patients) for 14 days. Treatment study visits occurred on day eight, day 15 and day 16; study outcomes included mean change in diurnal IOP as well as changes in PD, distance corrected near visual acuity (DCNVA) and conjunctival hyperemia.
The researchers concluded that “although mean IOP was not lowered significantly, daily evening dosing of 1% PMOS was found to be well tolerated with no daytime conjunctival redness and demonstrated improvement in DCNVA with sustained PD reduction in a glaucomatous and presbyopic population. Smaller pupil size can have beneficial effects in improving symptoms of presbyopia and DLD, which will be the focus of further studies.”
Pepose JS, Hartman PJ, DuBiner HB, Abrams MA, Smyth-Medina RJ, Moroi SE, Meyer AR, Sooch MP, Jaber RM, Charizanis K, Klapman SA, Amin AT, Yousif JE, Lazar ES, Karpecki PM, Slonim CB, McDonald MB. Phentolamine Mesylate Ophthalmic Solution Provides Lasting Pupil Modulation and Improves Near Visual Acuity in Presbyopic Glaucoma Patients in a Randomized Phase 2b Clinical Trial. January 2021Clinical ophthalmology (Auckland, N.Z.) Volume 15 DOI: 10.2147/OPTH.S278169