Second Phase III Study 202 Meets Primary Endpoint; Provides Additional Evidence of Efficacy and Safety –
– Long-term Phase III Study 203 Provides Additional Evidence of Safety –
– Company to Host Conference Call on Tuesday, May 7th at 12pm ET with Dr. Chuck Slonim and Dr. Shane Kannarr –
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.
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 |
| International | (409) 217-8312 |
| Conference ID | 7986401 |
| Webcast (live and replay) | www.osmotica.com under the “Investor & News” section |
The webcast will be archived for 30 days at the aforementioned URL.
