Osmotica Pharmaceuticals PLC (NASDAQ: OSMT) is working to treat ptosis, or droopy eyelid. While this can occur for a number of reasons, Osmotica has made some headway in the treatment of it.
Shares jumped on Tuesday after the firm announced results from its late-stage trial. Specifically, the Phase 3 trials are for RVL (oxymetazoline hydrochloride ophthalmic solution, 0.1%) for the treatment of ptosis.
Some quick background: Drooping or falling of the upper eyelid due to ptosis may be worse after being awake longer, when the individual’s muscles are tired. This condition is sometimes called “lazy eye,” but that term normally refers to the condition amblyopia.
Osmotica’s second Phase 3 study (202) met the primary endpoint, and the long-term Phase 3 study (203) provided evidence of safety.
The primary efficacy endpoint was the mean change from baseline in the RVL group compared with the placebo group in the number of points seen on the top four rows of the Leicester Peripheral Field Test (LPFT) in the study eye.
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. RVL administered once daily to patients was also generally well tolerated in this study.
Brian Markison, board chair and chief executive at Osmotica, commented:
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.
Shares of Osmotica traded up almost 5% to $4.07 early Tuesday, in a 52-week range of $3.54 to $9.90. The consensus price target is $14.75.