Participants

Key inclusion criteria were age ≥9 (studies RVL-1201-202, RVL-1201-203) or ≥18 years (studies RVL-1201-001, RVL-1201-201), presence of acquired blepharoptosis, defined by Marginal Reflex Distance 1 (MRD-1) ≤2.5 mm (study RVL-1201-001) or ≤2.0 mm (phase 3 studies), and superior visual field deficit (assessed via Humphrey Visual Field Test in study RVL-1201-001 and Leicester Peripheral Field Test (LPFT) in studies RVL-1201-201 and RVL-1201-202) in at least one eye. There was no superior visual field criterion in the 12-week study (RVL-1201-203). Individuals were excluded if they had pseudoptosis, congenital blepharoptosis, Marcus Gunn jaw-winking syndrome, Horner syndrome, mechanical blepharoptosis, myasthenia gravis, substantial dermatochalasis, or history of blepharoptosis surgery or periocular neurotoxin injection <3 months pre-enrollment. Potential participants were also excluded if, at screening, they had resting heart rate (HR) outside of the normal range (defined as 60–100 beats per minute [bpm] in studies RVL-1201-001 and RVL-1201-201, and 50–110 bpm in studies RVL-1201-202 and RVL-1201-203) or hypertension (defined as diastolic blood pressure (DBP) >105 mmHg in studies RVL-1201-001 and RVL-1201-201, and DBP > 105 mm Hg or systolic blood pressure (SBP) >220 mmHg in studies RVL-1201-202 and RVL-1201-203). The phase 1/2a study (RVL-1201-001) excluded individuals with advanced arteriosclerotic disease, history of myocardial infarction, angina, arrhythmia, or irregular pulse, as well as individuals using a beta blocker within 14 days preceding screening. The remaining studies excluded individuals with advanced arteriosclerotic disease and history of cerebrovascular accident. Notably, hypertension was the most common non-ocular medical history finding in the pooled population (50.4% and 48.2% of participants in the oxymetazoline 0.1% and vehicle groups, respectively).