Dataset Information

Omidenepag Isopropyl in Latanoprost Low/Non-Responders with Primary Open-Angle Glaucoma or Ocular Hypertension: A Phase 3, Non-Randomized, Two-Phase, Open-Label Study.

ABSTRACT:

Prcis

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.

SUBMITTER: Panarelli JF

PROVIDER: S-EPMC10681282 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature

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Publications

Omidenepag Isopropyl in Latanoprost Low/Nonresponders With Primary Open Angle Glaucoma or Ocular Hypertension: A Phase 3, Nonrandomized, Two-Phase, Open-Label Study.

Panarelli Joseph F JF Bowden Eileen C EC Tepedino Michael E ME Odani-Kawabata Noriko N Pei Zifan Z McLaurin Eugene B EB Ropo Auli A

Journal of glaucoma 20231017 12

<h4>Prcis</h4>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.<h4>Purpose</h4>The purpose of this study was to evaluate the intraocular pressure (IOP)-lowering efficacy and safety of OMDI in latanoprost low/nonresponders with POAG or OHT.<h4>Materials and methods</h4>Phase 3, nonrandomized, 2-phase, open-label, multi ...[more]

PMID: 37853676

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