Upneeq FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 17, 2020.
FDA Approved: Yes (First approved July 8, 2020)
Brand name: Upneeq
Generic name: oxymetazoline hydrochloride
Dosage form: Ophthalmic Solution
Company: Osmotica Pharmaceuticals plc
Treatment for: Blepharoptosis
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.
- Upneeq is administered by instilling one drop into one or both ptotic eye(s) once daily. Upneeq is supplied as single patient-use containers individually packaged in a foil pouch.
- Alpha-adrenergic receptor agonists as a class may impact blood pressure. Patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension or hypotension should seek medical care if their condition worsens.
- Patients with cerebral or coronary insufficiency or Sjögren’s syndrome should seek medical care if signs and symptoms of potentiation of vascular insufficiency develop.
- Patients should seek immediate medical care if pain, redness, blurred vision and photophobia occur (signs and symptoms of acute angle closure).
- Common adverse reactions (incidence 1-5%) include punctate keratitis, conjunctival hyperemia, dry eye, vision blurred, instillation site pain, eye irritation and headache.
Development Timeline for Upneeq
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