JAMA Ophthalmology Publishes Pooled Analysis of Data from two Phase 3 Clinical Trials of Upneeq (oxymetazoline hydrochloride, 0.1% solution) for Acquired Ptosis - Seite 2

The pooled analysis combined data from 2 randomized, double-masked, placebo-controlled, multicenter Phase 3 clinical trials (Study RVL-1201-201 and Study RVL-1201-202) totaling 304 participants including 203 receiving Upneeq and 101 receiving vehicle once daily as a single drop per eye for 42 days. Overall, 97.5% of participants receiving oxymetazoline 0.1% and 97.0% of participants receiving vehicle completed the studies.

The primary efficacy endpoint was change from baseline in the number of points seen on the Leicester Peripheral Field Test (LPFT), a test to detect superior visual field deficits due to ptosis, on days 1 (6 hours post-instillation) and 14 (2 hours post-instillation). The secondary endpoint, change from baseline in Marginal Reflex Distance 1 (MRD-1), was assessed at the same time points.

Key trial findings published in JAMA Ophthalmology include the following (Click HERE for the full text reprint):

• Increase from baseline in mean number of points seen on superior visual field (LPFT):
  • Day 1: 5.9 ± 6.4 (oxymetazoline 0.1%) versus 1.8 ± 4.1 (vehicle),
    • mean difference: 4.07 (95% CI: 2.74, 5.39), p<0.001
  • Day 14: 7.1 ± 5.9 (oxymetazoline 0.1%) versus 2.4 ± 5.5 (vehicle),
    • mean difference: 4.74 (95% CI: 3.43, 6.04), p<0.001
      

• Increase from baseline in upper eyelid elevation (MRD-1):
  • Day 1: 0.96 ± 0.89 mm (oxymetazoline, 0.1%) vs 0.50 ± 0.81 mm (vehicle),
    • mean difference: 0.47 mm (95% CI: 0.27, 0.67), p<0.001
  • Day 14: 1.16 ± 0.87 mm (oxymetazoline, 0.1%) vs 0.50 ± 0.80 mm (vehicle),
    • mean difference: 0.67 mm (95% CI: 0.46, 0.88), p<0.001

Treatment emergent adverse events (TEAEs) were observed in 31.0% of patients receiving Upneeq and 35.6% of patients receiving vehicle. Among participants receiving Upneeq and reporting a TEAE, 81% had a maximum TEAE intensity of mild. No serious TEAE was suspected of being treatment-related, and all were resolved.

There were no mean shifts from baseline in vital signs, or intraocular pressure, Snellen, visual acuity, pupil diameter, slit-lamp or ophthalmoscopy/fundus results in either eye judged to be clinical relevant.

In addition to 6-week efficacy trials, a randomized, double-masked, placebo-controlled, multicenter Phase 3 clinical trial was conducted to evaluate the safety of Upneeq over 12 weeks of once daily treatment. The results of this study will be reported separately.