Dosing & Uses
Dosage Forms & Strengths
ophthalmic solution
- 0.002% (0.02mg/mL)
Glaucoma or Ocular Hypertension
Indicated for reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension
1 drop in affected eye(s) qDay qPM
Safety and efficacy not established
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (0)
Minor (0)
Adverse Effects
1-10%
Conjunctival hyperemia (9%)
Photophobia (5%)
Vision blurred (4%)
Dry eye (3%)
Instillation site pain (3%)
Eye pain (2%)
Ocular hyperemia (2%)
Punctate keratitis (2%)
Headache (2%)
Eye irritation (1%)
Visual impairment (1%)
Warnings
Contraindications
None
Cautions
May gradually change eyelashes and vellus hair in treated eye; changes include increased length, thickness, and number of lashes or hairs; eyelash changes are usually reversible upon discontinuing treatment
Ocular inflammation reported; use with caution in patients with active ocular inflammation, including iritis/uveitis
Macular edema, including cystoid macular edema, reported; caution in aphakic patients, in pseudophakic patients, or in patients with known risk factors for macular edema
Advise patients to avoid touching bottle tip to eye or any surface, as this may contaminate solution
Advise patients not to touch tip to their eye to avoid the potential for injury to eye
Pigmentation changes
- Pigmentation changes are expected to occur and increase if omidenepag isopropyl ophthalmic solution is administered
- Pigmentation change is due to increased melanin content in melanocytes rather than increased number of melanocytes
- Iris color change may not be noticeable for several months to years
- Long term effects of pigmentation are not known
- The brown pigmentation around the pupil may spread concentrically towards the periphery ofthe iris and the entire iris or parts of the iris become more brownish
- Neither nevi nor freckles of the iris appear to be affected by treatment; while treatment can be continued in patients who develop noticeably increased iris pigmentation, examine regularly
- After discontinuing, iris pigmentation is likely to be permanent, while pigmentation of periorbital tissue and eyelash changes are reversible in most patients
- Inform patient receiving prostaglandin analogs of possible increased pigmentation, including permanent changes
Pregnancy & Lactation
Pregnancy
Data are unavailable on use in pregnant females
Animal data
- SC administration of omidenepag isopropyl to pregnant rabbits throughout organogenesis produced fetal skeletal anomalies at a dose of 24x the clinical dose, based on estimated peak plasma concentration
- Omidenepag isopropyl was not teratogenic in rats when administered SC at 1 mg/kg/day, 2,452x the clinical dose
Lactation
There are no data on drug presence in human milk, effects on breastfed infants, or effects on milk production
Systemic exposure to omidenepag following topical ocular administration is low, and it is unknown whether measurable levels of omidenepag would be present in maternal milk following topical ocular administration
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Prodrug of omidenepag
Relatively selective prostaglandin E2 (EP2) receptor agonist that decreases intraocular pressure (IOP)
Currently, exact mechanism of action is unknown
Elevated IOP represents a major risk factor for glaucomatous field loss
Higher IOP is likely to damage optic nerve and cause visual field loss
Absorption
Absorbed through cornea where prodrug omidenepag isopropyl is hydrolyzed to become biologically active metabolite, omidenepag
Peak plasma time: 10-15 min
Metabolism
Rapidly metabolized in the eye to omidenepag (active moiety) by carboxylesterase-1
Omidenepag is further metabolized by liver through oxidation, N-dealkylation, glucuronidation, sulfate conjugation, or taurine conjugation
Elimination
By 168 hr after ocular instillation, 89% of administered radioactive dose was excreted
Excretion: 83% (feces); 4% (urine)
Administration
Ophthalmic Administration
Remove contact lenses before administering solution; lenses may be reinserted 15 minutes after administration
Advise patients to avoid touching tip of bottle to eye or any surface, as this may contaminate solution
Advise patients not to touch tip to their eye to avoid potential eye injury
Gently shake bottle before administering
Storage
Unopened bottle
- Refrigerate at 2-8ºC (36-46ºF)
Opened bottle
- Store for up to 31 days at up to 30ºC (86ºF)
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Formulary
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