Eyeworld

In a phase 2b clinical trial, OMIDRIA was 4 to 6 times more e ective in preventing pupil diameter of < 6 mm than intracameral phenylephrine or ketorolac. 2 FDA-approved OMIDRIA is added to the irrigation solution used during cataract surgery and lens replacement for direct and continuous intracameral delivery of mydriatic and NSAID therapy. 1 In pivotal phase 3 clinical trials (N=808) in which all patients received standard topical mydriatics preoperatively, OMIDRIA was superior to placebo across all assessments of pupil size. In fact, 96% of OMIDRIA-treated patients had pupil diameter ≥ 6 mm at the time of lens implantation. 1,2,6 What you can expect with OMIDRIA ® (phenylephrine and ketorolac injection) 1% / 0.3% 50% more likely to be pain-free up to 12 hours after surgery and… 10 30% less likely to use oral analgesics on day of surgery 10 50% less likely to have moderate- to-severe pain while being… 10 TOPICAL MEDICATIONS CAN WASH OUT 7 Continuous delivery of OMIDRIA in the irrigation solution provides a steady-state concentration of ketorolac at the site of surgery. In a study of conventional phacoemulsifi cation and lens replacement performed with OMIDRIA in 20 canines, ketorolac levels measured throughout the structures of the eye were suffi cient to ablate COX-1 and -2 pathways for at least 10 hours postoperatively. 1,8,9, ‡ SUPERIOR TO PHENYLEPHRINE OR KETOROLAC ALONE* WITH OMIDRIA, NSAID IS DELIVERED THROUGHOUT SURGERY 1 In two pivotal phase 3 clinical trials § in which all patients received standard anesthetic agents preoperatively, patients treated with OMIDRIA were: OMIDRIA EFFECTIVELY REDUCES POSTOPERATIVE OCULAR PAIN 1 CONSISTENTLY MAINTAINS PUPIL DIAMETER 1 0 p<0.0001 p=0.0004 p=0.0216 10 20 30 40 50 Vehicle (n=53) Ketorolac (n=52) Phenylephrine (n=49) OMIDRIA (n=49) 46% 35% 22% 6% Patients (%) Percent of patients with pupil diameter <6 mm at any time during surgery 2, * Post hoc analysis 0 Placebo (n=180) OMIDRIA (n=184) Placebo (n=180) OMIDRIA (n=195) p<0.0001 p<0.0001 10 20 30 40 Study 1 Study 2 Patients (%) Pupil diameter <6 mm at start of lens implantation 2,6 23% 23% 4% 4% of patients receiving preoperative topical ketorolac had nominal or undetectable ketorolac levels at the end of the procedure. 7, † Topical ketorolac has been shown to wash out. In fact, in a study evaluating the presence of preoperative topical ketorolac at the end of cataract surgery: 100% Ketorolac tissue levels inhibited COX-1 and COX-2 pathways for at least 10 hours postoperatively 2,8,9 100 80 60 40 20 0 Time postsurgery (hr) Estimated inhibition (%) 0 2 4 6 8 10 Vitreous COX-1 COX-2 Retina COX-1 COX-2 COX-1 COX-2 Iris/Ciliary Body

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