Omeros' OMIDRIA Eye Drop OK'ed For Pediatric Use

Omeros Corporation OMER shares are trading higher Tuesday after the commercial-stage biopharma company announced FDA approval for its supplemental new drug application, or sNDA, for OMIDRIA, which expands the indication to include use in pediatric patients, from birth through 17 years old.

At the time of writing, shares of Omeros were more than 9 percent higher at $20.45.

The Drug

OMIDRIA, which has already been approved for use in adults, is a phenylephrine and ketorolac intraocular solution, used in 1 percent or 3 percent concentrations to treat intraoperative miosis, or pupil constriction during cataract surgery, with the treatment option also serving to reduce post-operative pain.

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The sNDA, accorded priority review status, was approved following presentation of efficacy and safety data from a pediatric clinical trial, which evaluated 78 pediatric patients randomized to either OMIDRIA or phenylephrine administered intra-operatively.

What Does The Approval Mean? 

Along with the label extension to pediatric patients, the FDA also granted an additional six months of market exclusivity for OMIDRIA. The patent for OMIDRIA is set to expire in October 2033. With the six-month additional market exclusivity granted by the FDA, generic versions from Novartis AG (ADR) NVS' Sandoz unit and Lupin can now hit the shelves only after April 2034.

OMIDRIA has a peak annual sales potential of about $1 billion, according to Motley Fool. In the recent third quarter, the company said OMIDRIA sales totaled $21.7 million, up 26 percent sequentially and a 92 percent year-over-year jump.

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