Omidenepag Isopropyl 0.002% Once Daily in Subjects with Prim
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This study was conducted to examine whether the efficacy and safety of omidenepag isopropyl 0.002% twice-daily (BID) dosing was superior to once-daily (QD) dosing in subjects with primary open-angle glaucoma or ocular hypertension.

Randomized subjects (1:1) received omidenepag isopropyl 0.002% QD (n=50) or BID (n=48) for 6 weeks. Intraocular pressure (IOP) was measured at 8:00 AM, 12:00 PM, and 4:00 PM at baseline and weeks 2 and 6. The primary efficacy endpoint was IOP at each timepoint at weeks 2 and 6. Adverse events (AEs) were evaluated.

Results:
--Baseline mean diurnal IOP (±SD) post-washout was 25.4±2.9 mmHg (BID) and 24.6±1.9 mmHg (QD).

--At weeks 2 and 6, clinically significant IOP reductions from baseline were observed for omidenepag isopropyl BID and QD treatments.

--Least-squares mean (±SE) IOP differences (BID versus QD) were not statistically significant (week 2: 0.44±0.68 to 1.08±0.65 mmHg; week 6: 0.36±0.63 to 0.68±0.68 mmHg) at any timepoint.

--AEs were threefold greater in the BID arm (41.7%; QD: 14.0%); the most frequently reported AE was conjunctival/ocular hyperemia (BID: 22.9%; QD: 2.0%).

--5 subjects discontinued omidenepag isopropyl prematurely, four/five owing to AEs (BID: 4; QD: 0).

Finally, the benefit-risk profile of omidenepag isopropyl 0.002 percent QD was found to be more favorable than that of BID. The BID arm had a higher incidence of local tolerability problems, which contributed to the gap.

Source: https://journals.lww.com/glaucomajournal/Abstract/9000/A_Randomized_Phase_2_Trial_Comparing_Omidenepag.97604.aspx
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