Précis:
This study demonstrates the efficacy and safety of once-daily 0.002% omidenepag isopropyl (OMDI) in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT) who do not respond or respond poorly to latanoprost.
Purpose:
To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of OMDI in latanoprost low/non-responders with POAG or OHT.
Materialsand Methods:
Phase 3, non-randomized, two-phase, open-label, multicenter study (NCT03697811) in the United States. Key inclusion criteria included individuals aged ≥18 years, POAG or OHT diagnosis in both eyes, IOP ≥22 mm Hg in ≥1 eye and ≤34 mm Hg in both eyes at all time points. Overall, 107 patients were enrolled; 104 completed treatment. Included a screening period (≤35-day washout period and 8-week latanoprost run-in period) and a 3-month treatment period comprising one drop of OMDI 0.002% once daily in both eyes. Primary study endpoint was change from baseline in mean diurnal (MD) IOP at month 3. Safety endpoints included incidence of adverse events (AEs), serious AEs, and adverse drug reactions.
Results:
At baseline (visit 4), 75 (70.1%) patients had POAG, 32 (29.9%) had OHT, and 68 (63.6%) had prior use of prostaglandin/prostaglandin analogs (37.4% of whom used latanoprost). Mean (standard deviation [SD]) baseline MD IOP was 23.34 mm Hg (2.12). Mean (SD) 3-month (visit 7) MD IOP change from baseline (following latanoprost run-in period and OMDI treatment period) was an additional decrease of 2.96 mm Hg (2.83) (P<0.0001). No significant safety issues were reported during OMDI treatment.
Conclusions:
These data demonstrate OMDI efficacy and safety in latanoprost low/non-responders with POAG or OHT, suggesting OMDI is a treatment option in the patient population in this study.