Omeros has received approval from the US Food and Drug Administration (FDA) for its Omidria for use during cataract surgery or intraocular lens replacement to maintain pupil size by preventing intraoperative miosis and to reduce postoperative pain.
Claimed to be the first commercial product from the company’s PharmacoSurgery platform, Omidria is a combination of the pupil-dilating agent phenylephrine (1%) and the anti-inflammatory agent ketorolac (0.3%).
According to Omeros, FDA approval comes with no post-marketing commitments other than the previously agreed study of Omidria for use in paediatric patients, which, if successfully completed, makes the drug eligible for an additional six months of marketing exclusivity in the US.
In pivotal clinical trials, Omidria showed statistically significant and clinically meaningful improvement in preventing miosis and reduction of postoperative pain relative to placebo.
Patients in these clinical trials received standard pupil-dilating and anesthetic agents prior to surgery.
Ocular adverse reactions observed in the trials included eye irritation, posterior capsule opacification, increased intraocular pressure and anterior chamber inflammation.
Omeros is expected to launch Omidria in the US around September.
Omeros chairman and CEO Gregory Demopulos said: "We have continued to round out our commercialisation team and are focused on obtaining European approval for Omidria, securing Medicare pass-through reimbursement and successfully launching the product in the US later this year.
"In parallel, our premier clinical and non-clinical programmes are advancing, and we look forward to sales of Omidria significantly defraying future development costs of our rich pipeline."
Currently, the European Medicines Agency is reviewing the marketing authorisation application for Omidria.