1. Mild, reversible ocular inflammation has been reported during clinical trials. Eybelis should be used with caution in patients with active ocular inflammation, including iritis/uveitis (see Adverse Reactions).
2. Macular edema including cystoid macular edema as well as iritis may occur. Patients should be instructed to immediately consult with medical professionals if they experience abnormalities such as worsening vision (see Adverse Reactions).
3. There is no clinical experience in patients with angle-closure glaucoma. It is advisable to use with caution in patients with angle-closure glaucoma.
4. Be careful not to touch the tip of the bottle to the eye directly in order to avoid the contamination of the drug.
5. If more than one topical ophthalmic product is being used, each one should be administered at least 5 minutes apart.
6. Benzalkonium chloride may change the color of the contact lenses. Contact lens wearers should remove the contact lenses before using this product and put them back 15 minutes or longer afterwards.
Effects on ability to drive and use machine: Because temporary blurred vision or photophobia may develop after instilling this product, patients should be instructed not to drive or to operate machines until the symptom disappears.
Use in Children: The safety and efficacy of omidenepag isopropyl in children and adolescents have not yet been established. No data are available.