Omeros announced the results of a real-world clinical study showing that its FDA-approved ophthalmic drug Omidria (phenylephrine and ketorolac intraocular solution) 1% / 0.3% decreases the incidence of postoperative cystoid macular edema (CME), a sight-threatening complication of cataract surgery. The study results were presented at the joint annual meeting of the American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators held in San DiegoMay 3-7, 2019.
The investigator-sponsored study was conducted by Keith A. Walter, MD, Professor of Ophthalmology at Wake Forest University School of Medicine. He conducted a retrospective analysis of 504 eyes (357 patients) on whom he had performed cataract surgery using Omidria plus only a topical non-steroidal anti-inflammatory drug (NSAID), assessing the incidence of CME. The control group consisted of a collection of single and meta-analytic studies published in the peer-reviewed literature in which steroids, with and without topical NSAIDs, were used in cataract surgery in the absence of Omidria. Of the 504 eyes treated with Omidria, only two developed postoperative CME, an incidence of 0.39 percent, which is 3- to 12-fold lower than the CME rates (a range of 1.2 percent to 5 percent) in the published peer-reviewed studies using steroids both with and without NSAIDs in the absence of Omidria.
“CME can be a horrendous sight-threatening complication of cataract surgery,” stated Dr. Walter. “To prevent CME, ophthalmic surgeons have routinely used topical NSAIDs together with steroids. This study confirms what we were seeing in practice – that use of Omidria reduces the incidence of CME. In fact, use of Omidria with only a topical NSAID precludes the need for steroids in cataract surgery, delivering a 3- to 12-fold decrease in the incidence of CME compared to studies in the peer-reviewed literature using steroids with and without topical NSAIDs. The result is not only increased convenience for the patient but, more important, meaningfully increased safety.”
A manuscript reporting details of the study is in preparation and is expected to be submitted for publication in a peer-reviewed journal.
Omidria (phenylephrine and ketorolac intraocular solution) 1% / 0.3% is the first and only FDA-approved product of its kind and is marketed in the U.S. for use during cataract surgery or intraocular lens replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain.