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 Most common ocular adverse reaction was blurred vision.
Blurred vision was reported in less than 4% of individuals.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 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 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.
In patients with DED, 614 patients received at least one dose of MIEBO in two randomized controlled clinical trials across 68 sites in the United States.
The most common ocular adverse reaction was blurred vision.
Blurred vision and conjunctival redness were reported in 1-3% of individuals.
In four premarketing studies (three open-label [n=127], one randomized [n=24 treated with at least one dose of perfluorohexyloctane]) the most common adverse reaction was hypersensitivity.
5 WARNINGS AND PRECAUTIONS 5.1 Use with Contact Lenses MIEBO should not be administered while wearing contact lenses.
Advise patients that contact lenses should be removed prior to and for at least 30 minutes after administration of MIEBO.
Like all medications, Miebo 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: