Omlonti FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 28, 2022.
FDA Approved: Yes (First approved September 22, 2022)
Brand name: Omlonti
Generic name: omidenepag isopropyl
Dosage form: Ophthalmic Solution
Company: Santen Inc.
Treatment for: Glaucoma/Intraocular Hypertension
Omlonti (omidenepag isopropyl) is a relatively selective prostaglandin E2 (EP2) receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
- Omlonti is thought to reduce elevated intraocular pressure by increasing aqueous humor drainage through the conventional (or trabecular) and uveoscleral outflow pathways.
- Omlonti is administered into the affected eye(s) once daily in the evening.
- Warnings and precautions associated with Omlonti include pigmentation, eyelash changes, ocular inflammation, and macular edema.
- Common adverse reactions include conjunctival hyperemia, photophobia, blurred vision, dry eye, instillation site pain, eye pain, ocular hyperemia, punctate keratitis, headache, eye irritation, and visual impairment.
Development timeline for Omlonti
Date | Article |
---|---|
Sep 26, 2022 | Approval FDA Approves Omlonti (omidenepag isopropyl ophthalmic solution) for Reduction of Elevated Intraocular Pressure in Primary Open-Angle Glaucoma or Ocular Hypertension |
Further information
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