Osmotica Pharmaceuticals plc Receives FDA Approval for Upneeq™ (oxymetazoline hydrochloride ophthalmic solution), 0.1% for Acquired Blepharoptosis (Droopy Eyelid) in Adults
-- First and only FDA-approved pharmacologic treatment for acquired blepharoptosis --
-- Company to host Investor Call at
The Company believes that millions of people have ptosis in
“With the approval of Upneeq, eye care specialists now have a safe and convenient non-surgical option to treat their patients who have ptosis. Upneeq has garnered a great deal of interest from ophthalmic physicians and key opinion leaders, or KOLs, and we are prepared to commercialize Upneeq and engage providers through our medical education outreach. We look forward to launching Upneeq through our subsidiary,
“Upneeq’s safety and efficacy profile and its once-a-day dosing provides a significant ophthalmic therapeutic innovation. Given the previous absence of any approved medical treatment options, ptosis has been often under-diagnosed or overlooked. Upneeq has the potential to address a significant unmet need in ptosis therapy,” stated Tina deVries, Ph.D., Executive Vice President, Research and Development.
“This approval marks a critical milestone for Osmotica, as we continue to execute our corporate strategy. Looking ahead, we see Upneeq as a significant growth catalyst and an important opportunity to bring value to our shareholders while addressing a significant unmet medical need with a first-in-class product,” concluded Markison.
Osmotica plans to make Upneeq commercially available next month to a selected group of ophthalmologists and optometrists through an early experience program.
The Company remains actively engaged in discussions with ex-
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 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.
The Company will host a conference call as follows:
|Toll free (
|Webcast (live and replay)
|www.osmotica.com under the “Investor & News” section
IMPORTANT SAFETY INFORMATION
UPNEEQ™ (oxymetazoline hydrochloride ophthalmic solution), 0.1% is indicated for the treatment of acquired blepharoptosis in adults.
WARNINGS AND PRECAUTIONS
- Alpha-adrenergic agonists as a class may impact blood pressure. Advise UPNEEQ patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension or hypotension to seek medical care if their condition worsens.
- Use UPNEEQ with caution in patients with cerebral or coronary insufficiency or Sjögren’s syndrome. Advise patients to seek medical care if signs and symptoms of potentiation of vascular insufficiency develop.
- UPNEEQ may increase the risk of angle closure glaucoma in patients with untreated narrow-angle glaucoma. Advise patients to seek immediate medical care if signs and symptoms of acute narrow-angle glaucoma develop.
- Patients should not to touch the tip of the single patient-use container to their eye or to any surface, in order to avoid eye injury or contamination of the solution.
Adverse reactions that occurred in 1-5% of subjects treated with UPNEEQ were punctate keratitis, conjunctival hyperemia, dry eye, blurred vision, instillation site pain, eye irritation and headache.
- Alpha-adrenergic agonists, as a class, may impact blood pressure. Caution in using drugs such as beta‑blockers, anti-hypertensives, and/or cardiac glycosides is advised. Caution should also be exercised in patients receiving alpha adrenergic receptor antagonists such as in the treatment of cardiovascular disease, or benign prostatic hypertrophy.
- Caution is advised in patients taking monoamine oxidase inhibitors which can affect the metabolism and uptake of circulating amines.
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.
Upneeq (oxymetazoline hydrochloride ophthalmic solution), 0.1% is a novel, once-daily ophthalmic formulation of oxymetazoline, a direct-acting alpha adrenergic receptor agonist, which when administered to the eye, is believed to selectively target Müller’s muscle and elevate the upper eyelid. Upneeq is the first and only FDA-approved pharmacologic treatment indicated for the treatment of acquired blepharoptosis (ptosis, or droopy eyelid).
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Source: Osmotica Holdings US LLC