NDA 205388, held by Rayner Surgical. Ketorolac Tromethamine; Phenylephrine Hydrochloride.
As of Nov 15, 2026, NDA 205388 (Omidria), held by Rayner Surgical, was first approved by FDA on May 30, 2014, with 5 approved supplements and 0 published complete response letters.
Omidria is added to an ocular irrigating solution used during cataract surgery or intraocular lens replacement and is indicated for maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain. OMIDRIA is an alpha 1-adrenergic receptor agonist and nonselective cyclooxygenase inhibitor indicated for: Maintaining pupil size by preventing intraoperative miosis Reducing postoperative pain OMIDRIA is added to an ocular irrigating solution used during cataract surgery or intraocular lens replacement.
| Dec 8, 2017 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| May 30, 2014 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| OmidriaEQ 0.3% BASE;EQ 1% BASE · solution;irrigation | Ketorolac Tromethamine; Phenylephrine Hydrochloride | RxReference drug |
| Dec 8, 2017 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Oct 27, 2016 | Supplement 4Manufacturing | Approved | None posted |
| Jul 8, 2016 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jan 15, 2016 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| May 21, 2015 | Supplement 1Manufacturing · Standard review | Approved | |
| May 30, 2014 | Original applicationNew combination · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
