Upneeq Generic Name & Formulations
Store at 20°C to 25°C (68°F to 77°F).
Protect from excessive heat.
Store single patient-use containers in the child-resistant foil pouches.
Discard opened containers immediately after use.
Upneeq Dosage and Administration
Upneeq Boxed Warnings
There are no available data on Upneeq use in pregnant women.
Nursing Mother Considerations
No clinical data available to assess the effects of oxymetazoline on breastmilk production, or to establish the level of oxymetazoline present in human breastmilk. Consider the benefits to the mother vs the potential risks to the breastfed child.
Safety and effectiveness of Upneeq have not been established in pediatric patients under 13 years of age.
No overall differences in safety or effectiveness observed between patients 65 years and older and younger patients.
Following ocular administration, time to reach peak oxymetazoline concentration (Tmax) values ranged from 0.5 to 12 hours with a median Tmax of 2 hours.
Upneeq Adverse Reactions
Upneeq Clinical Trials
Approval was based on data from 2 double-masked, vehicle-controlled, parallel-group phase 3 trials (Trial 1 and Trial 2) that evaluated the efficacy and safety of Upneeq in 304 patients with acquired blepharoptosis. Patients were randomly assigned 2:1 to receive Upneeq once daily or vehicle for 42 days.
The primary endpoint was the mean change from baseline in the number of points seen on the Leicester Peripheral Field Test in the study eye at hour 6 on day 1 and hour 2 on day 14. A secondary end point included the change from baseline in marginal reflex distance 1 (MRD1).
In both studies, improvement in superior visual field was observed with Upneeq at the 2-hour time point and maintained at the 6-hour time point. Results from Trial 1 (N=140) showed that Upneeq met the primary endpoint demonstrating a statistically significant improvement at hour 6 on day 1 (mean difference 3.7; 95% CI, 1.8-5.6; P <.01) and at hour 2 on day 14 (mean difference 4.2; 95% CI, 2.0-6.0; P <.01) vs vehicle.
Additionally, statistically significant improvements in the Upneeq treatment arm were noted in Trial 2 (N=164) at hour 6 on day 1 (mean difference 4.2; 95% CI, 2.4-6.1; P <.01) and at hour 2 on day 14 (mean difference 5.3; 95% CI, 3.7-7.1; P <.01) vs vehicle. Both studies demonstrated greater MRD1 increases at both time points vs vehicle.
Upneeq Patient Counseling
Contact lenses: Remove prior to administration; reinsert 15 minutes after administration.
Allow 15 minutes between applications of other ophthalmic drugs.
Upon opening, use the single patient-use container immediately; any remaining contents should be discarded after administration.
Do not touch the tip of the container to the eye or to any surface.
Consideration should be given to neurologic or orbital diseases (egg, stroke and/or cerebral aneurysm, Horner syndrome, myasthenia gravis, external ophthalmoplegia, orbital infection and orbital masses) in the presence of ptosis with decreased levator muscle function and/or other neurologic signs.
Patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension or hypotension: Alpha-adrenergic agonists may impact blood pressure.