Additional Clinical Studies Supporting the Benefits of OMIDRIA® Presented at the American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators Annual Meeting
--OMIDRIA demonstrates clear benefits across traditional and femtosecond laser-assisted cataract surgery and in IFIS cases--
The first presentation, a retrospective analysis, assessed whether the use of OMIDRIA in femtosecond laser-assisted cataract surgery (FLACS) – a procedure that is known to cause miosis (pupil constriction) due to the increased inflammation generated by the laser – leads to a reduction in the need for pupil expansion devices and in surgical time. Investigators compared 100 consecutive femtosecond-assisted cataract procedures in which epinephrine was used in the irrigation solution to 100 consecutive femtosecond-assisted procedures performed with OMIDRIA. In the epinephrine group, 12 eyes (12 percent) required a Malyugin Ring® to maintain or improve pupil size versus 2 eyes (2 percent) in the OMIDRIA group (p=0.009). Surgical times in the OMIDRIA group were reduced by an average of 78 seconds compared to those in the epinephrine group (p = 0.007). The authors conclude that use of OMIDRIA achieves faster surgery and a more manageable pupil.1
The second clinical study assessed the effects of OMIDRIA on pupil dilation when used early in patients undergoing both FLACS and traditional cataract surgery. A total of 77 patients underwent either traditional phacoemulsification (n=57) or FLACS (n=20), all of whom received OMIDRIA in the irrigation solution and administered through the side-port incision at the beginning of the case. Pupil diameter was measured before and after OMIDRIA administration as well as prior to intraocular lens (IOL) insertion. In the traditional phacoemulsification cases, the mean pupil diameter was 6.65 mm at baseline and 7.42 mm intraoperatively before IOL insertion. Similarly, in the FLACS group, the mean pupil diameter was 6.69 mm at baseline and 7.65 mm prior to IOL insertion. The study demonstrates that OMIDRIA is effective in maintaining and even increasing pupil size in traditional as well as in femtosecond laser-assisted cataract procedures, which, without OMIDRIA, frequently induce miosis.2
A third study evaluated the effect of OMIDRIA on pupil dilation, iris billowing and iris prolapse in patients at high risk for intraoperative floppy iris syndrome (IFIS). The randomized, double-masked, investigator-initiated study enrolled 50 male subjects (50 eyes) who had been exposed to tamsulosin (Flomax®), a prostate drug that causes IFIS, prior to cataract surgery. The 50 patients were randomized 1:1 to receive either OMIDRIA or control. All subjects underwent routine cataract surgery recorded endoscopically from the perspective of the ophthalmic microscope. Investigators assessed pupil diameter and IFIS symptoms in all 50 subjects (50 eyes). Mean pupil diameter during surgery for the control group was 5.92mm and was 7.08mm for the OMIDRIA-treated group (p < 0.001). Symptoms of IFIS were observed in all 25 (100 percent) patients in the control group and in only 3 (12 percent) of patients who received OMIDRIA. Iris prolapse occurred in 14 (56 percent) subjects in the control group versus 3 (12 percent) in the OMIDRIA group. Iris billowing, graded according to a new grading scale for intraoperative iris abnormalities, averaged 2.36 in the control group and 1.68 in the treatment group, with Stage 3 (severe) billowing seen in 10 (40 percent) vehicle subjects and 1 (4 percent) treatment subject. All of the comparisons related to IFIS symptoms were statistically significant with p < 0.001. The authors conclude that OMIDRIA offers significant benefits in IFIS cases and could reduce the complexity and unpredictability of such cases.3
A fourth study assessed clinical outcomes and surgical practice patterns for cataract patients treated with either OMIDRIA or epinephrine. This retrospective chart review included patients who received treatment at one of two clinics by a single surgeon practicing at both locations. A total of 635 eyes in 375 patients underwent cataract surgery with either OMIDRIA (n=275) or epinephrine (n=360) in the irrigation solution. Mean surgical time was significantly shorter with OMIDRIA versus epinephrine (16.5 min vs 17.8 min; p = 0.006), and only 6 (2.2 percent) pupil expansion devices were required in the OMIDRIA group vs 24 (6.7 percent) in the epinephrine group (p = 0.008). Investigators conclude that OMIDRIA reduced surgical time and decreased the need for pupil expansion devices compared to the use of intracameral epinephrine.4
Detailed descriptions of all four clinical studies have been accepted for publication by, or are planned for submission to, peer-reviewed journals.
Omeros’ OMIDRIA® (phenylephrine and ketorolac intraocular
solution) 1% / 0.3% is the first and only
Important Safety Information for OMIDRIA®
Systemic exposure of phenylephrine may cause elevations in blood pressure. In clinical trials, the most common reported ocular adverse reactions at two percent or greater are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation; incidence of adverse events was similar between placebo-treated and OMIDRIA-treated patients. OMIDRIA must be added to irrigation solution prior to intraocular use.
In addition to Omeros’ commercial drug OMIDRIA,
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1Miosis Prevention in Femtosecond-Assisted Cataract
Surgery Using a Continuous Infusion of Phenylephrine and Ketorolac.
Walter K, Delwadia N
2Effect of Early Phenylephrine and Ketorolac Injection 1%/0.3% on Pupil Diameter in Traditional and Femtosecond-Assisted Cataract Surgery. Gayton J.
3Effect of Phenylephrine and Ketorolac Injection on Intraoperative Floppy Iris Syndrome. Silverstein S., Rana V.
4Clinical Outcomes of Phenylephrine/Ketorolac (1%/0.3%) vs. Epinephrine in Cataract Surgery in a Real-World Setting. Matossian C.
Cook Williams Communications, Inc.
Jennifer Cook Williams
Investor and Media Relations