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OMIDRIA EFFECTIVELY MAINTAINS PUPIL DILATION

In Study 1, when patients were treated with OMIDRIA vs placebo, there was an 83% reduction with pupil diameters of <6 mm. In Study 2, when patients were treated with OMIDRIA vs placebo, there was an 83% reduction with pupil diameters of <6 mm.

  • 96% of OMIDRIA-treated patients had pupil diameter ≥6 mm at the start of lens implantation1-3
  • Real-world evidence shows that OMIDRIA can benefit ALL patient types, not just high-risk patients4-6

OMIDRIA is the 1st and only FDA-approved non-opioid, NSAID-containing treatment for maintaining pupil size and reducing postoperative pain by preventing intraoperative miosis.1

Randomized, parallel-group, double-masked, placebo-controlled, phase 3 study (N=402)2

In a phase 3 study, patients undergoing unilateral cataract extraction and lens replacement or refractive lens exchange were randomized 1:1 to OMIDRIA or placebo

All patients received mydriatic treatment, anesthesia, and pre- and postoperative antibiotic treatment.2
All patients were discharged with paracetamol. Postoperative evaluations were conducted for up to 14 days.2

Randomized, parallel-group, double-masked, placebo-controlled, phase 3 study (N=406)3

In a phase 3 study, patients undergoing unilateral cataract extraction and lens replacement or refractive lens exchange were randomized 1:1 to OMIDRIA or placebo

All patients received mydriatic treatment, anesthesia, and pre- and postoperative antibiotic treatment.3
All patients were discharged with paracetamol. Postoperative evaluations were conducted for up to 90 days.3

Provides superior miosis prevention vs phenylephrine or ketorolac alone

6% of patients treated with OMIDRIA had pupil diameter <6mm vs 47% Vehicle, 35% Ketorolac, 22% Phenylephrine

Randomized, double-masked, clinical study7

OMIDRIA was 4-6 times more effective in miosis prevention than either ketorolac or phenylephrine alone.7

Randomized, double-masked, vehicle-controlled, parallel, multicenter, phase 2 study (N=222)7

In a phase 2 study, patients went through cataract surgery with insertion of an acrylic IOL

Before cataract surgery, pupillary function was assessed via a swinging-flashlight test, and preoperative topical anesthetics were applied.7

REAL-WORLD EVIDENCE

OMIDRIA reduces the use of PEDs and surgical time

OMIDRIA reduces the use of PEDs and surgical time for a more comfortable surgery experience5,6,8,9

In patients treated with OMIDRIA, the use of PEDs was reduced by 67.2% compared to Epinephrine (6.7% vs 2.2%). In patients treated with OMIDRIA, the surgical time was reduced by 7.3% compared to Epinephrine (17.8% vs 16.5%).

  • Mean surgical time with OMIDRIA was significantly shorter compared to epinephrine (10.1 vs 14.3 minutes; P=0.0068) in high-risk patients6
  • Mean surgical time with OMIDRIA was significantly shorter compared to epinephrine (8.10 vs 9.39 minutes; P=0.007) in femtosecond laser-assisted cataract surgeries9

Retrospective chart review (N=635)8

In a retrospective review, one surgeon performed cataract surgery at a single clinic

Data were manually extracted from patient medical records on site at the clinic and compiled with all personal identifying information removed. Data were collected from the surgery date through a minimum of 4-6 weeks post surgery.8

REFERENCES: 1. OMIDRIA [package insert]. Seattle, WA: Omeros Corporation; 2017. 2. Data on file. 3. Lindstrom RL, Loden JC, Walters TR, et al. Intracameral phenylephrine and ketorolac injection (OMS302) for maintenance of intraoperative pupil diameter and reduction of postoperative pain in intraocular lens replacement with phacoemulsification. Clin Ophthalmol. 2014;8:1735-1744. 4. Rosenberg ED, Nattis AS, Alevi D, et al. Visual outcomes, efficacy, and surgical complications associated with intracameral phenylephrine 1.0%/ketorolac 0.3% administered during cataract surgery. Clin Ophthalmol. 2018;12:21-28. 5. Bucci FA Jr, Michalek B, Fluet AT. Comparison of the frequency of use of a pupil expansion device with and without an intracameral phenylephrine and ketorolac injection 1%/0.3% at the time of routine cataract surgery. Clin Ophthalmol. 2017;11:1039-1043. 6. Visco D. Effect of phenylephrine/ketorolac on iris fixation ring use and surgical times in patients at risk of intraoperative miosis. Clin Ophthalmol. 2018;12:301-305. 7. Donnenfeld ED, Whitaker JS, Jackson MA, Wittpenn J. Intracameral ketorolac and phenylephrine effect on intraoperative pupil diameter and postoperative pain in cataract surgery. J Cataract Refract Surg. 2017;43(5):597-605. 8. Matossian C. Clinical and economic outcomes in cataract surgery using phenylephrine 1.0%-ketorolac 0.3% in a real-world setting. Presented at: ASCRS ASOA Annual Meeting 2018; April 13-17, 2018; Washington, DC. 9. Walter K, Delwadia N, Coben J. Continuous intracameral phenylephrine–ketorolac irrigation for miosis prevention in femtosecond laser–assisted cataract surgery: reduction in surgical time and iris manipulation. J Cataract Refract Surg. 2019;45(4):465-469.

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