Drug updated on 12/11/2024
| Dosage Form | Solution (topical ophthalmic; 0.002% [0.02 mg/mL]) |
| Drug Class | Relatively selective prostaglandin E2 (EP2) receptor agonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Latest News
Summary
- This summary is based on the review of four randomized controlled trial(s). [1-4]
- Omidenepag Isopropyl (OMDI) vs Latanoprost (Primary Outcome: intraocular pressure (IOP) Reduction at Month 3): OMDI reduced IOP by 7.1 mmHg (28.8%) compared to Latanoprost’s reduction of 7.8 mmHg (31.3%), with a least-squares mean difference of 0.6 mmHg (95% confidence interval (CI): 0.0, 1.2 mmHg; p = 0.0366), confirming non-inferiority.
- OMDI vs Timolol (IOP-Lowering Efficacy Over 3 and 12 Months): OMDI showed IOP reductions of -5.6 to -5.9 mmHg (SPECTRUM 4) and -5.3 to -5.7 mmHg (SPECTRUM 3), while Timolol reduced IOP by -5.4 to -6.1 mmHg (SPECTRUM 4) and -6.4 to -7.0 mmHg (SPECTRUM 3), demonstrating consistent non-inferiority over both short- and long-term periods.
- Long-term IOP Reduction Over 52 Weeks (Group Comparisons): OMDI showed sustained IOP reductions: Group 1 (-3.7 mmHg), Group 2 (-5.6 mmHg), and Group 3 with Timolol (-8.4 mmHg).
- Adverse events (AEs) occurred in 40.0% of the OMDI group and 29.7% of the Latanoprost group. Ocular AEs were more common with OMDI (36.8%) compared to Latanoprost (21.1%), with treatment-associated ocular AEs reported in 23.2% of OMDI patients versus 11.9% in the Latanoprost group. Conjunctival hyperemia was more frequent with OMDI (11.9%) compared to Latanoprost (5.4%). Most AEs were mild, and no serious ocular AEs were observed.
- Conjunctival hyperemia occurred in 18.8% of patients in monotherapy groups and 45.0% in concomitant therapy groups. Macular edema or cystoid macular edema (ME/CME) was reported in 11.8% of monotherapy patients and 15.0% of those on concomitant therapy. No serious treatment-related AEs were observed, and most AEs were mild.
- OMDI demonstrated non-inferior efficacy in reducing IOP among Asian subjects with open-angle glaucoma or ocular hypertension and among Japanese patients, while prolonged OMDI use was associated with increased macular edema in pseudophakic patients. Pediatric patients were included, but no specific outcomes were provided for this subgroup.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Omlonti (omidenepag isopropyl) Prescribing Information. | 2022 | Santen Incorporated, Emeryville, CA |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Omidenepag Isopropyl 0.002% versus Latanoprost 0.005% in Open-Angle Glaucoma/Ocular Hypertension: The Randomized Phase III PEONY Trial | 396Subjects F: 47% M: 53% | 2024 | Clinical Ophthalmology |
| Omidenepag Isopropyl Versus Timolol in Patients With Glaucoma or Ocular Hypertension: Two Randomized Phase 3 Trials (SPECTRUM 4 and 3) | 834Subjects F: 59% M: 41% | 2024 | American Journal of Ophthalmology |
| Twelve-month efficacy and safety of omidenepag isopropyl, a selective EP2 agonist, in open-angle glaucoma and ocular hypertension: the RENGE study | Data not availableSubjects F: null% M: null% | 2021 | Japanese Journal of Ophthalmology |
| Omidenepag Isopropyl Versus Latanoprost in Primary Open-Angle Glaucoma and Ocular Hypertension: The Phase 3 AYAME Study | 189Subjects F: 54% M: 46% | 2020 | American Journal of Ophthalmology |
Sex Distribution:
F:47%
M:53%
396Subjects
Year:
2024
Source:Clinical Ophthalmology
Sex Distribution:
F:59%
M:41%
834Subjects
Year:
2024
Source:American Journal of Ophthalmology
Sex Distribution:
Year:
2021
Source:Japanese Journal of Ophthalmology
Document Title
Sex Distribution:
F:54%
M:46%
189Subjects
Year:
2020
Source:American Journal of Ophthalmology