Osmotica Pharma (OSMT) Announces Positive Topline Results of Phase III Clinical Trials of RVL-1201 for Acquired Blepharoptosis
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Osmotica Pharmaceuticals plc (“Osmotica” or the “Company”) (Nasdaq: OSMT), a fully integrated biopharmaceutical company, today announced positive topline results of its second Phase III efficacy and safety clinical trial (Study 202) of RVL (oxymetazoline hydrochloride ophthalmic solution, 0.1%) and long-term Phase III safety study (Study 203) for the treatment of ptosis (droopy eyelid).
“We are very pleased with the positive topline results of our second Phase III clinical Study 202 of RVL for the treatment of ptosis evaluating efficacy and safety compared to placebo. Our topline readout is consistent with our prior study results, which demonstrated a statistically significant improvement in the visual field of patients that were administered our once-daily drop. The topline readout also suggests that RVL was well tolerated by patients in this study. Given the positive topline results from this study, combined with our recently completed long-term safety Study 203, we intend to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the third quarter of 2019. If approved, we could be on the market as early as the second half of 2020,” said Brian Markison, Chairman and Chief Executive Officer at Osmotica.
“We believe there is a large prevalence of ptosis and today there is no FDA-approved pharmacologic intervention for any of these patients. If approved, RVL would be the first non-surgical option available for patients. Administered as a single drop once daily, RVL has the potential to significantly improve the visual field of individuals living with the clinical sequelae of ptosis,” added Markison.
Study Design and Outcomes
Osmotica conducted a second Phase III, randomized, multicenter, double-masked, placebo-controlled, 6-week study (Study 202) to evaluate the efficacy and safety of a once-daily treatment of RVL compared to placebo for the treatment of ptosis.
Study 202 randomized 164 subjects (109 subjects on RVL and 55 subjects on placebo) in a 2:1 randomization scheme.
The primary efficacy endpoint was the mean change from baseline in the RVL group versus placebo group in the number of points seen on the top 4 rows of the Leicester Peripheral Field Test (LPFT) in the study eye at each of the following time points:
- Day 1 Hour 6
- Day 14 Hour 2
The increases at both time points in the number of points seen in the superior visual field (change in LPFT) in the RVL group compared to the placebo group were highly statistically significant (p < 0.0001). RVL administered once daily to patients was also generally well tolerated in this study. The overall incidence of adverse events (AEs) was similar to that of placebo.
The topline results from Study 202 are consistent with the results of Osmotica’s previously reported Phase III Study 201, which evaluated the efficacy and safety of RVL in patients with ptosis.
Additionally, Osmotica conducted a 12-week, randomized, multicenter, double‑masked, placebo‑controlled Phase III study (Study 203) to evaluate the long term safety of RVL compared with placebo in the treatment of ptosis. The study included 234 patients (157 RVL and 77 Placebo) who were randomized in a 2:1 ratio, receiving either RVL or placebo once a day. RVL was generally well tolerated in this study, and the AEs that were observed were predominantly mild in intensity. A total of 50 subjects (31.8%) in the RVL group and 23 subjects (29.9%) in the placebo group reported AEs. There were no deaths during the study. Two subjects in the RVL group experienced a Serious AE that were not considered related to study medication.
Brian Markison (Chief Executive Officer), JD Schaub (Chief Operating Officer), Tina deVries (EVP Research and Development), David Jacobs (VP Clinical Development), Dr. Chuck Slonim (Key Opinion Leader), and Dr. Shane Kannarr (Key Opinion Leader), will host a conference call as follows:
|Date||Tuesday, May 7, 2019|
|Time||12:00 p.m. EDT|
|Toll free (U.S.)||(866) 672-5029|
|Webcast (live and replay)||www.osmotica.com under the “Investor & News” section|
The webcast will be archived for 30 days at the aforementioned URL.
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