As the phenylephrine and ketorolac (1%/0.3% injection), Omidria was US FDA approved on May 30, 2014 - for maintaining pupil size (by preventing intraoperative miosis and for reducing postoperative pain) in adults. In all, we expect Omidria sales to ramp up due to the additional approval for pediatrics.
Since launched, Omidria’s revenues are increasing to power the firm’s developing pipeline of highly promising therapeutics like OMS-721 that we elucidated in the prior research. The existing sales for the adult population are most likely to also gain more traction.
The elephant in the room is whether the stock will continue to appreciate going into 2018. Asides Par, Omeros is asserting against private firms, Sandoz Inc. in the Hatch-Waxman litigation planned for trial in mid-2019 in the US District Court of Delaware.
In this report, we’ll go over the recent FDA approval of the supplemental New Drug Application (“s NDA”) for Omidria (and to revisit the investing thesis on Omeros). If Omeros wins the case, the company is expected to have the market exclusivity against those two firms until April 2034.
If you received your report in the mail, please call us to update.