Approved indications: Omlonti is FDA-approved to reduce elevated intraocular pressure in adults with open-angle glaucoma or ocular hypertension; its safety and effectiveness have not been established in children or adolescents.

Off-label uses: Outside its labeled indication, omidenepag has been studied and may be considered by specialists for related conditions such as normal-tension glaucoma or certain secondary or angle-closure glaucomas, but these uses are off-label in the United States and supported mainly by smaller clinical studies and real-world series.

Efficacy expectations:

• Eye pressure usually begins to decrease within hours of starting therapy, with a stable effect over several days to a few weeks.
• In clinical trials, average intraocular pressure reductions were roughly 5–7 mm Hg from baseline, and many patients maintained pressures in a range considered protective for the optic nerve.
• Head‑to‑head studies show Omlonti provides pressure lowering similar to timolol and to prostaglandin F‑analog drops such as latanoprost, making it a reasonable first-line or switch option when other agents are insufficient or poorly tolerated.

Typical dosing:

• Adults with open-angle glaucoma or ocular hypertension: Instill one drop into the affected eye or eyes once daily in the evening.
• The same dose is used in older adults; there are no recommended adjustments based solely on age.
• Use in children and adolescents has not been established and, if considered, should be directed by an eye specialist.

How to use the drops:

• Wash and dry your hands, gently shake the bottle, and remove contact lenses before use.
• Tilt your head back, pull down the lower eyelid to form a small pocket, and place one drop into the pocket without letting the bottle tip touch the eye or any surface.
• After instilling a drop, gently close the eye and press a finger at the inner corner of the eye for about 1–2 minutes to reduce drainage into the nose and throat.
• Wait at least 5 minutes between Omlonti and any other eye drops; apply ointments last.
• Contact lenses can be reinserted 15 minutes after using the drops.

Special dosing instructions:

• Use Omlonti at approximately the same time each evening; do not change the dosing time or stop suddenly without consulting your eye care provider.
• Do not use more than one dose per day in a given eye unless specifically instructed, as using extra doses is unlikely to improve pressure control and may increase side effects.

Missed dose:

• If you forget a dose and remember later the same day, apply it as soon as you remember.
• If it is close to the time of the next evening dose, skip the missed dose and resume your regular schedule the next day.
• Do not instill extra drops or use the medication more than once in a day to “make up” for a missed dose.

Overdose:

• Accidentally instilling more than one drop in an eye is unlikely to cause serious problems; gently blot away excess liquid with a clean tissue if this occurs.
• If someone swallows the medicine or if a large overdose is followed by severe eye pain, marked redness, or vision changes, seek medical advice promptly or contact a poison control center.

Common side effects:

• Redness of the eye (conjunctival or ocular hyperemia), mild eye discomfort or stinging at the time of instillation, and dry eye symptoms are among the most frequently reported effects, typically occurring in about a few to around 1 in 10 users.
• Other common effects include blurred vision right after the drop, sensitivity to light, eye pain or irritation, punctate keratitis (small surface spots on the cornea), headache, and a feeling of visual disturbance; these are usually mild to moderate and often lessen with continued use.
• Cosmetic changes such as gradual eyelash growth (longer, thicker, darker lashes) and darkening of the skin of the eyelids can emerge over weeks to months.

Serious or rare adverse effects (seek immediate care):

• Severe eye pain, a sudden drop or change in vision, marked light sensitivity, or seeing a dark spot or distortion in the center of vision (possible macular edema).
• Signs of serious eye inflammation or infection, such as intense redness, swelling of the eye or eyelids, pus-like discharge, or intense photophobia.
• Possible allergic reactions, including eyelid swelling, rash around the eye, or difficulty breathing.
• Rapid, noticeable change in iris color (more brown pigment), which is usually permanent, though not dangerous; this does not require emergency care but should be reported.

Warnings and precautions:

• Eye conditions: Use with caution in people with active or recurrent uveitis/iritis, a history of macular edema, aphakia, or pseudophakia with a torn posterior capsule, because of increased risk of inflammation or macular edema.
• Contact lenses: The drops contain benzalkonium chloride, which can be absorbed by soft lenses and irritate the eye; remove lenses before instilling a dose and wait at least 15 minutes before reinserting.
• Pregnancy: Human pregnancy data are lacking; animal studies show developmental effects only at exposures far above clinical levels, so use is generally reserved for situations where the potential benefit justifies any potential risk.
• Breastfeeding: It is unknown whether the drug is excreted into human milk; systemic exposure from eye use is low, so risk is thought to be small, but the decision to use it while nursing should be individualized.
• Children: Safety and effectiveness have not been established in patients under 18 years of age.
• Kidney or liver disease: No specific dose adjustments are defined, and systemic absorption is low, but clinicians may exercise caution in severe organ impairment.

Safety compared with similar drugs: Compared with traditional prostaglandin F‑analog glaucoma drops, Omlonti provides similar pressure lowering, tends to cause less eyelid and orbital fat atrophy, but may be associated with a somewhat higher rate of eye redness and certain corneal surface changes; systemic side effects appear rare with all of these topical agents.

Reporting side effects and safety updates: Side effects should be reported to a healthcare professional and can also be reported directly to the FDA MedWatch program (by phone or online) to help monitor ongoing safety information.

Drug and product interactions:

• Other eye drops: Omlonti can be used with other glaucoma or lubricating eye drops, but they should be spaced at least 5 minutes apart; ointments should be applied after all drops.
• Other prostaglandin-type agents: Using more than one prostaglandin or EP‑receptor agonist eye drop at the same time is generally avoided unless an eye specialist specifically recommends it, because it may increase side effects without clear added benefit.
• Contact lenses and solutions: Benzalkonium chloride in the formulation can be absorbed by soft lenses and may irritate the eye, so lenses must be removed before use and reinserted after at least 15 minutes.
• Systemic medicines, supplements, foods, and alcohol: Because systemic absorption from the eye is very low, clinically significant interactions with oral medicines, supplements, food, or alcohol are not expected, though all medications should still be reviewed with your prescriber.

Precautions and conditions needing extra care:

• History of uveitis or other intraocular inflammation, or current red, inflamed eyes.
• Aphakia or pseudophakia with a torn posterior capsule, or prior macular edema or retinal vein occlusion.
• Recent or planned cataract or other intraocular surgery, where the surgeon may adjust therapy to reduce the risk of macular edema.
• Severe dry eye, corneal disease, or a history of corneal erosions, in which closer monitoring of the ocular surface may be needed.
• Pregnancy, breastfeeding, or potential for pregnancy, given limited human safety data.

Monitoring needs:

• Regular eye examinations with measurement of intraocular pressure to confirm and maintain adequate pressure control.
• Periodic assessment of the optic nerve and visual fields to monitor glaucoma progression.
• In patients at risk for macular edema or with prior retinal disease, eye care providers may perform periodic retinal or macular evaluations.
• Long‑term users should be monitored for iris color changes, eyelid skin darkening, eyelash changes, and corneal surface health.

Q: What is Omlonti used for?
A: Omlonti is an eye drop prescribed to lower high eye pressure in adults who have open-angle glaucoma or ocular hypertension, helping reduce the risk of optic nerve damage and vision loss.

Q: How long does it take for Omlonti to start working?
A: Eye pressure usually begins to fall within hours of starting Omlonti, but your doctor typically checks the full effect over days to weeks and adjusts treatment based on pressure readings and your exam.

Q: Can I use Omlonti with my other glaucoma drops?
A: Omlonti is often used alone but can be combined with other pressure-lowering eye drops when needed; each medication should be given at least 5 minutes apart, and any changes to combinations should be guided by your eye specialist.

Q: Will Omlonti change my eye color or eyelashes?
A: Omlonti can gradually darken the colored part of the eye (especially in mixed-color irises) and may cause eyelashes on the treated eye to grow longer, thicker, and darker; eyelash changes usually reverse after stopping, but iris color changes are typically permanent.

Q: Do I need to keep Omlonti in the refrigerator?
A: Unopened bottles should be stored in the refrigerator, but once a bottle is opened it can be kept at room temperature (up to 86°F / 30°C) for up to 31 days, after which any remaining solution should be discarded.

Storage: Store unopened bottles in the refrigerator (about 36°F to 46°F / 2°C to 8°C); after opening, the bottle may be kept at room temperature (up to 86°F / 30°C) for up to 31 days, kept tightly closed, protected from freezing, and out of the reach of children.

Disposal: Do not use the drops after the printed expiration date or after 31 days from first opening, and discard any remaining solution and used bottles in household trash according to pharmacist or local guidance rather than flushing them down the toilet or sink.