Safety and Efficacy Study of RVL-1201 in Acquired Blepharoptosis

Inclusion Criteria

• Adult male or female subjects 18 years of age and older.
• Presence of all of the following at Screening:
• Loss on HVF 36-point ptosis protocol test of ≥ 8 points in points not seen at or above 10° from fixation in the superior visual field; AND
• Marginal reflex distance (MRD), the distance from the central pupillary light reflex to the upper lid margin, of ≤ 2.5 mm in the same eye as Inclusion Criterion #2a; AND
• Corrected Snellen visual acuity (VA) of 20/40 or better (refraction must be within 6 months of Visit 1) in the same eye as Inclusion Criteria #2a and #2b.
• No contraindications for treatment of both eyes as specified in Exclusion Criteria #1-14.
• Female subjects must be 1-year postmenopausal, surgically sterilized, or women of childbearing potential with a negative urine pregnancy test at Visit 1. Women of childbearing potential must use an acceptable form of contraception throughout the study.
• Provide informed consent prior to undergoing any study-related procedures.

Exclusion Criteria

In either eye:

• Congenital ptosis
• Pseudoptosis
• Horner syndrome
• Marcus Gunn jaw-winking syndrome
• Myasthenia gravis
• Mechanical ptosis, including ptosis due to orbital or lid tumor, cicatricial processes affecting the movements of the upper lid, and enophthalmos
• Dermatochalasis as the sole cause of the signs of ptosis
• Previous ptosis surgery
• Lid position affected by lid or conjunctival scarring
• Current use of prescribed dry eye medication or punctal plugs; artificial tears are allowed
• Visual field loss from any cause other than ptosis
• Inability to fixate on the central fixation target of the HVF
• Primary open-angle glaucoma or ocular hypertension, intraocular pressure (IOP) > 24 mm Hg, or current use/use within 1 month prior to Visit 1 of any antiglaucoma medications.
• History of closed/narrow angle glaucoma (unless patent peripheral iridotomy has been performed > 3 months prior to Visit 1 and IOP 105 mm Hg
• Use of monoamine oxidase inhibitors (MAOIs; eg, isocarboxazid, phenelzine, tranylcypromine) within 14 days prior to Visit 1 or during the study
• Use of beta blockers (eg, propranolol, metoprolol, labetalol) within 14 days prior to Visit 1 or during the study
• Use of maprotiline, selective serotonin reuptake inhibitors ([SSRIs] eg, citalopram, escitalopram, paroxetine, fluoxetine, fluvoxamine, sertraline) or tricyclic antidepressants (eg, amitriptyline, doxepin, nortriptyline, amoxapine, clomipramine, desipramine, imipramine, protriptyline, trimipramine) at any time during the study
• A history of myocardial infarction, angina, arrhythmia, or irregular pulse
• Advanced arteriosclerotic disease
• History of thyroid disease
• Insulin-dependent diabetes or diabetes requiring oral hypoglycemic drugs; diet-controlled diabetes is allowed
• Pregnancy or lactation
• Diagnosed benign prostatic hypertrophy requiring medicinal therapy.
• History of contact or systemic allergic reaction to oxymetazoline or other sympathomimetic drugs (eg, phenylephrine, pseudoephedrine, ephedrine, phenylpropanolamine, fepradinol, or methoxamine)