Osmotica Pharmaceuticals PLC (NASDAQ:OSMT) recently announced that Upneeq, its innovative treatment for ptosis or acquired blepharoptosis, received regulatory approval from the FDA.
Acquired blepharoptosis is a medical condition where the patient’s eyelid droops unusually, affecting the patient’s vision. The FDA’s regulatory approval represents a milestone achievement for Osmotica because Upneeq is officially the first ptosis treatment to be approved by the FDA. According to Osmotica, millions of people suffer from the condition in the U.S and perhaps more in Europe, China, and Japan. Thus, the approval is a step in the right direction and a step closer to a solution for ptosis patients.
Previous studies conducted using upneeq on ptosis patients yielded noteworthy improvements. The studies also revealed an effective and safe treatment for the condition thanks to results collected from double-masked efficacy studies. Side effects observed during the clinical trials involving the treatment were mild.
“With the approval of Upneeq, eye care specialists now have a safe and convenient non-surgical option to treat their patients who have ptosis,” stated Osmotica CEO, Brian Markison.
Markison also revealed that Upneeq received a lot of attention from opinion leaders and ophthalmic physicians. The company is currently working towards commercializing the treatment through its subsidiary, RVL Pharmaceuticals, Inc. Osmotica will also ensure the treatment’s widespread availability through its pharmacy network.
Tina deVries, the head of Research and Development at Osmotica stated that Upneeq is considered as an innovative ophthalmic therapy thanks to its efficacy and safety profile. It is also a convenient treatment since it only requires a single daily dose, and there is also the added advantage of being the first to market for a particular health condition. No other ptosis treatment has ever received regulatory approval, which means that Upneeq is uniquely positioned to deliver strong revenue growth.
Markison even described the treatment as a growth catalyst in his statement in which he also pointed out that it will allow the company to deliver strong value for shareholders. All this while providing a solution to patients who previously did not have any treatment alternative.