Ptosis therapy gets first-in-category FDA nod

Osmotica Pharmaceuticals has received U.S. Food and Drug Administration (FDA) approval of Upneeq (oxymetazoline hydrochloride ophthalmic solution), 0.1%, the only FDA-approved medical treatment for Ptosis, which occurs when one or both upper eyelids sag. Ptosis often stems from a partial or complete dysfunction of Müller’s muscle, which lifts the eyelid, according to the company. In severe cases, the condition can limit field of vision.

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Upneeq, formerly known as RVL-1201, is a non-surgical option to treat ptosis patients that relies on a once-daily topical ophthalmic formulation of oxymetazoline, a direct-acting alpha adrenergic receptor agonist.

In the company’s clinical studies conducted for FDA approval, the drug showed clinically significant improvements in ptosis patients when 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 2 pivotal double-masked efficacy studies. A third pivotal study positively demonstrated that Upneeq was well tolerated when administered once daily, in the morning, to both eyes, over a 12-week period.

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The bulk of adverse reactions observed were:

• Punctate keratitis

• Conjunctival hyperemia

• Dry eye

• Blurred vision

• Eye irritation

• Pain

Upneeq’s approval represents a significant ophthalmic therapeutic innovation and has the potential to address a large treatment gap for patients who suffer from acquired blepharoptosis, according to JD Schaub, chief operating officer of RVL Pharmaceuticals, a subsidiary of Osmotica.

“In particular, optometrists will have a novel service/treatment which has historically been unavailable with the ability to expand the medical scope of their practices,” he says. “Until now, we understand ptosis to be an often under-diagnosed or overlooked condition. The opportunity to develop a new treatment paradigm and partner with ODs to elevate awareness and experience what Upneeq does will be game-changing.”

As the only FDA approved drug for ptosis, Osmotica’s market share of Upneeq is currently uncapped, according to investment website Benzinga. Osmotica is planning to sell Upneeq commercially as soon as next month as a 0.3 mL single patient-use container in 15- and 30-count cartons. The company is working with partners outside of the U.S to begin international distribution.

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