Osmotica Pharma (OSMT) Catches Eyes

osmoticapharmaceuticals june13 lt

Shares of Osmotica Pharmaceuticals plc (OSMT) closed at a new 52-week high of $8.77 on Friday (Jul.10), and that reflects a gain of 150% in just three months.

The Company, which has been generating revenue from promoted specialty neurology and women's health products, as well as from non-promoted products, which are primarily complex formulations of generic drugs, will soon have one more product to contribute to its revenue, thanks to the recent FDA approval.

On July 9, the FDA approved Osmotica's Upneeq eye drop, formerly known as RVL-1201, for acquired blepharoptosis, or ptosis, a condition characterized by the abnormal drooping of the upper eyelid that can limit the field of vision.

Acquired blepharoptosis, also known as ptosis, usually occurs from a partial or complete dysfunction of the muscles that elevate the upper eyelid. This can be caused by aging or an eye injury, or sometimes happens as a side effect after certain eye surgery, according to the American Academy of Ophthalmology. The current standard of care is surgery, which is often reserved only for severe cases.

Osmotica's Upneeq, which is the first and only FDA-approved pharmacologic treatment for acquired blepharoptosis, is expected to be made commercially available in August to a selected group of ophthalmologists and optometrists through an early experience program.

Another regulatory event to watch out for is the FDA decision on the Company's resubmitted New Drug Application for Arbaclofen extended-release tablets, proposed for the alleviation of spasticity in Multiple Sclerosis patients.

In July 2016, the FDA refused to approve Arbaclofen extended-release tablets citing irregularities and deviations from good clinical practices at the study sites for the initial phase III trial.

The resubmitted NDA for Arbaclofen ER includes the full results of the Company's second phase III efficacy study also.

Spasticity, which refers to feelings of stiffness, is one of the more common and disabling symptoms of multiple sclerosis. It is estimated that nearly 1 million people in the U.S. suffer from multiple sclerosis, of which 84% of them experience spasticity.

In the first quarter of 2020, total revenue declined to $48.6 million from $57.1 million in the year-ago quarter as a result of declining sales of methylphenidate ER and Venlafaxine ER tablets due to additional competition from current competitors, as well as additional generic product approvals.

At the end of the first quarter of 2020, the Company had $126 million in cash and $271 million in total debt.

The Company is expected to report second-quarter financial results next month.

OSMT has traded in a range of $2.70 to $9.67 in the last 1 year. The stock closed Friday's trading at $8.77, up 25.29%.

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