Vertical 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)
“We are delighted that our NDA has been accepted for filing. Today, there are no pharmacologic options approved for treatment of droopy eyelid. If approved, RVL would offer physicians and patients a therapeutic option for the treatment of ptosis supported by compelling safety and efficacy data from three well-controlled pivotal studies. With the simplicity of using a once-daily eye drop, RVL has the potential to transform the clinical treatment of acquired blepharoptosis,” said
“We look forward to continuing to engage with key opinion leaders and the medical community to build awareness of this novel therapeutic option for the treatment of droopy eyelid. As we build out our commercial and educational strategy for RVL, we are focused on messaging and pre-launch preparation activities that target both ophthalmologists and optometrists,” concluded Markison.
About Acquired Blepharoptosis
Acquired blepharoptosis 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 and may carry an increased risk of adverse events such as infection, bleeding, and asymmetry.
RVL-1201 is a novel, once-daily ophthalmic formulation of oxymetazoline, a direct-acting α-adrenergic receptor agonist, which when administered to the eye is believed to selectively target Müller’s muscle and elevate the upper eyelid. If approved, RVL-1201 will be the first pharmacologic treatment option for the wide range of patients suffering from droopy eyelid.
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