Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Pigmentation [see Warnings and Precautions (5.1) ] Eyelash Changes [see Warnings and Precautions (5.2) ] Ocular Inflammation [see Warnings and Precautions (5.3) ] Macular Edema [see Warnings and Precautions (5.4) ] The most common adverse reactions with incidence ≥ 1% are 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%), and visual impairment (1%).
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ocuvex at 1-877-622-9326 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to Omlonti in 600 patients for up to 3 months .
The most common adverse reactions with incidence ≥ 1% are 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%), and visual impairment (1%).
5 WARNINGS AND PRECAUTIONS Pigmentation ( 5.1 ) Eyelash changes ( 5.2 ) Ocular Inflammation ( 5.3 ) Macular Edema ( 5.4 ) 5.1 Pigmentation Omlonti (omidenepag isopropyl ophthalmic solution) 0.002%, is a prodrug of omidenepag, a relatively selective EP2 receptor agonist.
Pigmentation is expected to increase as long as omidenepag isopropyl ophthalmic solution is administered.
The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes.
After discontinuation of Omlonti, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes are likely to be reversible in most patients.
Patients who receive prostaglandin analogs, including Omlonti, should be informed of the possibility of increased pigmentation, including permanent changes.
Like all medications, Omlonti can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: