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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

Jul  9, 2020Approval FDA Approves Upneeq (oxymetazoline hydrochloride ophthalmic solution) for Acquired Blepharoptosis (Droopy Eyelid) in Adults
Nov 20, 2019Vertical Pharmaceuticals, LLC, an Osmotica Company, Announces Acceptance of New Drug Application by FDA for RVL-1201 (Oxymetazoline Hydrochloride Ophthalmic Solution, 0.1%) for Acquired Blepharoptosis (Droopy Eyelid)
Sep 17, 2019Vertical Pharmaceuticals, LLC, an Osmotica Company, Announces Submission of New Drug Application for RVL-1201

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.