Osmotica Pharmaceuticals PLC said its subsidiary Vertical Pharmaceuticals LLC filed for U.S. approval of its medicine to treat drooping eyelids.
Vertical is developing RVL-1201 to treat acquired blepharoptosis, or ptosis, which is characterized by partial or complete dysfunction of the muscles that elevate the upper eyelid.
The Sayreville, N.J.-based pharmaceutical company submitted a new drug application for RVL-1201 on the basis of results from two efficacy studies and one long-term safety study.
If approved, RVL-1201 will be the first pharmacologic treatment option available to ptosis patients. Surgery is the standard of care in severe ptosis cases and carries a greater risk of infection or asymmetry.
Osmotica plans to commercially sell RVL-1201, if approved, as early as the second half of 2020, the company said in a Sept. 17 press release.
