OMLONTI (omidenepag isopropyl)
Omlonti (omidenepag isopropyl ophthalmic solution) 0.002% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. By lowering IOP, the medication helps mitigate a primary risk factor for optic nerve damage and glaucomatous visual field loss.
How OMLONTI Works
Omidenepag isopropyl is a relatively selective prostaglandin E2 (EP2) receptor agonist that decreases intraocular pressure. While the exact downstream mechanism by which it achieves this reduction is currently unknown, targeting these receptors facilitates the management of elevated IOP to prevent visual field loss.
Details
- Status
- Prescription
- First Approved
- 2022-09-22
- Patent Cliff
- 2039
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION
OMLONTI Approval History
What OMLONTI Treats
2 indicationsOMLONTI is approved for 2 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Open-Angle Glaucoma
- Ocular Hypertension
OMLONTI Competitive Set
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Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in OMLONTI's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications OMLONTI treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to OMLONTI
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
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Key Completed Trials
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
OMLONTI FDA Label Details
Indications & Usage
FDA Label (PDF)OMLONTI is indicated for the treatment of Open-Angle Glaucoma; Ocular Hypertension.
OMLONTI Patents & Exclusivity
Patents (13 active)
Exclusivity
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Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2039
- • 13 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.