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Osmotica subsidiary seeks US FDA approval for drug to treat drooping eyelids

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.