Upneeq is the only FDA-approved prescription eyedrop for acquired ptosis (low-lying lids) that lifts your upper eyelids to open your eyes.
Osmotica Pharmaceuticals plc Receives FDA Approval for Upneeq™ (oxymetazoline hydrochloride ophthalmic solution), 0.1% for Acquired Blepharoptosis (Droopy Eyelid) in Adults.
Upneeq eyedrops for Droopy Eyelid
Upneeq (oxymetazoline hydrochloride ophthalmic solution, 0.1%) is a once-daily ophthalmic formulation of the direct-acting alpha-adrenergic receptor agonist oxymetazoline indicated for the treatment of acquired blepharoptosis, or ptosis, a condition characterized by the abnormal drooping of the upper eyelid. its novel treatment for acquired blepharoptosis, or ptosis, a condition characterized by the abnormal drooping of the upper eyelid that can limit the field of vision.
Upneeq is a safe and effective, first-in-class treatment for acquired ptosis, which often results from a partial or complete dysfunction of Müller’s muscle, which in conjunction with the Levator superioris, elevates the eyelid. Upneeq demonstrated statistically significant improvements compared to placebo in both superior visual field, as measured by the Leicester Peripheral Field Test (LPFT), and eyelid lift, as measured by the Marginal Reflex Distance Test (MRD-1) in two pivotal double-masked efficacy studies. A third pivotal safety study successfully showed that Upneeq was well tolerated when administered once daily in the morning (to both eyes) over a 12-week period. The majority of adverse events were mild and self-limited. (1)
Fixing Ptosis without Surgery
As per the American Academy of Ophthalmology website the prescription eyedrop provides an alternative to surgery and off-label drugs, the only options for fixing droopy eyelid until now. Upneeq eye drops works on a muscle that elevates the eyelid. It causes that muscle to contract, allowing the eyelid to open 1-2 millimetres wider than before treatment.
Price of Upneeq Eye Drop in the United States of America
According to Osmotica Pharmaceuticals, the company that develops Upneeq eye drop cost is $105 for a 30-day supply.
About Acquired Blepharoptosis
Acquired blepharoptosis, also known as ptosis, or droopy eyelid, is a unilateral or bilateral drooping of the upper eyelid that usually occurs from a partial or complete dysfunction of the muscles that elevate the upper eyelid. It can generally be classified as congenital or acquired, with the most common type being age-related aponeurotic ptosis. The current standard of care is surgery, which is often reserved only for severe cases
Clinical Studies of Upneeq Eye Drops
Results from Upneeq’s initial Phase III efficacy clinical trial showed that the formulation met its primary efficacy endpoints, which were a change in baseline visual field as measured by the LPFT, on Hour 6, Day 1 (p=0.0003) and Hour 2, Day 14 (p< 0.0001). Patients who received Upneeq once daily experienced a statistically significant improvement in visual field when compared to the placebo group. The 2:1 randomized, double-masked, placebo-controlled study was comprised of 140 patients with acquired blepharoptosis split into two treatment groups for 42 days.
Upneeq eye drops was well tolerated by patients in this clinical trial when administered once daily over a six-week period. There were no serious adverse events identified from treatment with Upneeq in this Phase III clinical trial.
The second Phase III efficacy trial was a six-week randomized, multicenter, double-masked, placebo-controlled study to evaluate the safety and efficacy of once-daily treatment of Upneeq compared with placebo for the treatment of acquired blepharoptosis. The primary endpoint for both trials was a measurement of the mean change from baseline of the number of points seen out of a total of 35 in the top four rows of the LPFT as measured in two time points: Hour 6, Day 1 and Hour 2, day 14. The secondary endpoint was a measurement of the distance between the center of the pupillary light reflex and the upper eyelid margin, or MRD-1. Topline results from the second Phase III efficacy trial showed that the trial met both the primary and secondary endpoints. The mean change from baseline on the LPFT on Hour 6, Day 1 was 6.3 for Upneeq versus 2.1 for vehicle (p < 0.0001) and on Hour 2, Day 14 was 7.7 for Upneeq versus 2.4 for vehicle (p < 0.0001). The results also showed a statistically significant improvement in MRD-1 at 5 and 15 minutes, and 2 and 6 hours post dose on days 1 and 14. The Company also completed a 12-week randomized, multicenter, double-masked, placebo controlled safety study to evaluate the safety of Upneeq compared with vehicle for the treatment of acquired blepharoptosis.
Side effects
The most common adverse reactions with UPNEEQ (occurring in 1-5% of patients) were eye inflammation, eye redness, dry eye, blurred vision, eye pain at the time of use, eye irritation, and headache.
Note: UPNEEQ belongs to a class of medication (alpha-adrenergic agonists) that may affect your blood pressure. Use UPNEEQ carefully if you currently take an alpha-adrenergic agonist medication to treat heart disease or an enlarged prostate. Patients taking beta-blockers, or other medications to treat hypertension or an abnormal heartbeat, should also be careful when using UPNEEQ.
Learn more: Visit Patient Information
References:
1. LLC, O. (2020). Osmotica Pharmaceuticals plc Receives FDA Approval for Upneeq™ (oxymetazoline hydrochloride ophthalmic solution), 0.1% for Acquired Blepharoptosis (Droopy Eyelid) in Adults. Retrieved 18 September 2020, from https://www.globenewswire.com/news-release/2020/07/09/2059809/0/en/Osmotica-Pharmaceuticals-plc-Receives-FDA-Approval-for-Upneeq-oxymetazoline-hydrochloride-ophthalmic-solution-0-1-for-Acquired-Blepharoptosis-Droopy-Eyelid-in-Adults.html
2. (2020). Retrieved 18 September 2020, from https://ir.osmotica.com/node/7186/pdf
3. Glasses May Protect Against COVID-19, S., Pink Eye May Be a Symptom of COVID-19 in Children, N., & Eyes?, D. (2020). First Prescription Fix for Droopy Eyelid. Retrieved 18 September 2020, from https://www.aao.org/eye-health/news/first-prescription-fix-droopy-eyelid
