Medical and Scientific Publications

Many of the nonconfidential advances in our premier research and development pipeline, as well as data from investigator-initiated studies showing the benefits of our marketed drug OMIDRIA in “real-world” settings, are shared through an extensive list of peer-reviewed publications and posters presented at international conferences.

OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1% /
0.3% Publications:

2020

Real-world opioid prescribing after cataract surgery among patients who received intracameral phenylephrine and ketorolac 1.0%/0.3%

Jackson K, Wisely CE, Davis B, Griffin B, Kim T. Curr Med Res Opin. 2020 Oct 30;1-6. Online ahead of print.

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Safety and efficacy data supporting U.S. FDA approval of intracameral phenylephrine and ketorolac 1.0%/0.3% for pediatric cataract surgery: clinical safety and pupil and pain management

Wilson ME, Trivedi RH, Plager DA. J Cataract Refract Surg. 2020 Jun;46(6):873-878.

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Effect of intracameral phenylephrine/ketorolac 1.0%/0.3% on postoperative cystoid macular edema, iritis, pain and photophobia following cataract surgery

Visco DM, Bedi R. J Cataract Refract Surg. 2020 Jun;46(6):867-872.

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Rate of pseudophakic cystoid macular edema using intraoperative and topical nonsteroidal antiinflammatory drugs alone without steroids

Walter K, Kauffman L, Hess J. J Cataract Refract Surg. 2020 Mar;46(3):350-354.

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2019

Effect of intracameral phenylephrine and ketorolac 1%/0.3% on intraoperative pain and opioid use during cataract surgery

Donnenfeld ED, Shojaei RD. Clin Ophthalmol. 2019:13:2143-50.

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Continuous intracameral phenylephrine-ketorolac irrigation for miosis prevention in femtosecond laser-assisted cataract surgery: Reduction in surgical time and iris manipulation

Walter K, Delwadia N, Cohen J. J Cataract Refract Surg. 2019 Apr;45(4):465-469.

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2018

Medical and surgical management of the small pupil during cataract surgery

Al-Hashimi S, Donaldson K, Davidson R, et al; ASCRS Refractive Cataract Surgery Subcommittee. J Cataract Refract Surg. 2018;44:1032-1041.

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Visual outcomes, efficacy, and surgical complications associated with intracameral phenylephrine 1.0%/ketorolac 0.3% administered during cataract surgery

Rosenberg ED, Nattis AS, Alevi D, et al. Clin Ophthalmology. 2018;12:21-28.

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Effect of phenylephrine 1.0%-ketorolac 0.3% injection on tamsulosin-associated intraoperative floppy-iris syndrome

Silverstein SM, Rana VK, Stephens R, et al. J Cataract Refract Surg. 2018;44(9):1103-1108.

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Effect of phenylephrine/ketorolac on iris fixation ring use and surgical times in patients at risk of intraoperative miosis

Visco DM. Clin Ophthalmology. 2018;12:301-305.

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Alternative drug delivery for patients undergoing cataract surgery as demonstrated in a canine model

Waterbury LD. J Ocul Pharmacol Ther. 2018;34:154-160.

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2017

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

Bucci FA, Michalek B, Fluet AT. Clin Ophthalmology. 2017;11:1039-1043.

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Intracameral ketorolac and phenylephrine effect on intraoperative pupil diameter and postoperative pain in cataract surgery

Donnenfeld ED, Whitaker JS, Jackson MA, Wittpenn J. J Cataract Refract Surg. 2017;43:597-605.

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Intracameral ketorolac concentration at the beginning and end of cataract surgery following preoperative topical ketorolac administration

Katsev DA, Katsev CC, Pinnow J, Lockhart CM. Clin Ophthalmology. 2017;11:1897-1901.

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Importance of pupil dilation for cataract surgery

Mamalis N. J Cataract Refract Surg. 2017;43(5):583-584.

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2016

Patient considerations in cataract surgery – the role of combined therapy using phenylephrine and ketorolac

Gonzalez-Salinas R, Guarnieri A, Guirao Navarro MC, Saenz-de-Viteri M. Patient Prefer Adherence. 2016;10:1795-1801.

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2015

Intracameral phenylephrine and ketorolac during cataract surgery to maintain intraoperative mydriasis and reduce postoperative ocular pain: Integrated results from 2 pivotal phase 3 studies

Hovanesian JA, Sheppard JD, Trattler WB, et al. J Cataract Refract Surg. 2015;41:2060-2068.

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The clinical utility of new combination phenylephrine/ketorolac injection in cataract surgery

Lawuyi LE, Gurbaxani A. Clin Ophthalmology. 2015;9:1249-1254.

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OMS302 (phenylephrine and ketorolac injection) 1%/0.3% to maintain intraoperative pupil size and to prevent postoperative ocular pain in cataract surgery with intraocular lens replacement

Osher RH, Ahmed IIK, Demopulos GA. Expert Rev Ophthalmol. 2015;10(2):91-103.

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2014

Management of mydriasis and pain in cataract and intraocular lens surgery: review of current medications and future directions

Grob SR, Gonzalez-Gonzalez LA, Daly MK. Clin Ophthalmology. 2014;8:1281-1289.

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Intracameral phenylephrine and ketorolac injection (OMS302) for maintenance of intraoperative pupil diameter and reduction of postoperative pain in intraocular lens replacement with phacoemulsification

Lindstrom RL, Loden JC, Walters TR, et al. Clin Ophthalmology. 2014;8:1735-1744.

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Narsoplimab (OMS721) Publications:

Narsoplimab is an investigational product not approved by any regulatory agency.

2020

Narsoplimab (OMS721) For the Treatment of Adult Hematopoietic Stem Cell Transplant-associated Thrombotic Microangiopathy

Rambaldi A, Smith M, Whitaker S, Khaled S. EHA 2020. Oral Presentation S262. June 12, 2020.
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2019

MASP-2 levels Following Allogeneic Hematopoietic Stem Cell Transplantation in Adults: Correlation with Development of a Thrombotic Microangiopathy and Implications for Therapy with Anti-Complement Agents

Elhadad S, Van Biesen K, Chapin J, Ahamed J, Laurence J. Poster presented at: American Society of Hematology 2019 Annual Meeting; Dec 7-10, 2019; Orlando, FL.
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Interim results from an ongoing phase 2 study evaluating the use of a MASP-2 inhibitor for the treatment of IgA nephropathy

Barratt J, Leifke E, Whitaker S, et al. Presented at: European Renal Association-European Dialysis and Transplant Association (ERA-EDTA). June 13-16, 2019. Budapest, HU. Poster FP201.

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2018

Cardioprotection by an anti-MASP-2 antibody in a murine model of myocardial infarction

Clark JE, Dudler T, Marber MS, Schwaeble W. Open Heart. 2018;5(1):e000652. doi:10.1136/openhrt-2017-000652.

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Improved survival following OMS721 treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HCT-TMA)

Rambaldi A, Khaled S, Smith M, et al. Presented at: European Hematology Association (EHA); June 15, 2018; Stockholm, Sweden.

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2017

The effect of OMS721 on proteinuria in patients with IgA nephropathy

Block G, Whitaker S. Presented at: European Renal Association—European Dialysis and Transplant Association (ERA-EDTA); June 4, 2017; Madrid, Spain.

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Maintenance of remission following completion of OMS721 treatment in Patients with IgA nephropathy (IgAN)

Block G, Whitaker S. Presented at: American Society of Nephrology (ASN); November 6, 2017; New Orleans, LA.

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Effective treatment of GvHD-associated transplant-associated microangiopathy

Caprioli C, Grassi A, Micò C, Rambaldi A. Presented at: European Society for Blood and Marrow Transplantation (EBMT); October 19-20, 2017; Granada, Spain.

Early results of a phase 2 study using OMS721 in patients with hematopoietic stem cell transplant-associated thrombotic microangiopathy (HCT-TMA)

Khaled SK, Kwong YL, Smith M, Metjian A, Whitaker S. Presented at: American Society of Blood and Marrow Transplantation (ASBMT); February 25, 2017; Orlando, FL.

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Dose-finding clinical trial of OMS721 for the treatment of atypical hemolytic uremic syndrome (aHUS) – stage 1 results

Nowicki M, Wiecek A, Massart A, Weekers L, Whitaker S, Miglinas M. Presented at: World Congress of Nephrology (WCN); April 21-25, 2017; Mexico City, Mexico.

Lectin pathway effector enzyme mannan-binding lectin-associated serine protease-2 can activate native complement C3 in absence of C4 and/or C2

Yaseen S, Demopulos G, Dudler T, et al. FASEB J. 2017;31(5):2210-2219. doi:10.1096/fj.201601306R.

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Resolution of acute kidney injury secondary to TA-TMA by the anti-MASP-2 monoclonal antibody OMS721 in a pediatric HSCT recipient

Zecca M, Comoli P, Mina T, Decembrino N, et al. Presented at: European Society for Blood and Marrow Transplantation (EBMT); March 26-29, 2017. Marseille, France.

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2016

Mannan binding lectin-associated serine protease-2 (MASP-2) critically contributes to post-ischemic brain injury independent of MASP-1

Orsini F, Chrysanthou E, Dudler T, et al. J Neuroinflammation. 2016;13(1):213. doi:10.1186/s12974-016-0684-6.

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2014

Mannan-binding lectin-associated serine protease 2 is critical for the development of renal ischemia reperfusion injury and mediates tissue injury in the absence of complement C4

Asgari E, Farrar CA, Lynch N, et al. FASEB J. 2014;28(9):3996-4003. doi:10.1096/fj.13-246306.
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2011

Targeting of mannan-binding lectin-associated serine protease-2 confers protection from myocardial and gastrointestinal ischemia/reperfusion injury

Schwaeble WJ1, Lynch NJ, Clark JE,et al. Proc Natl Acad Sci USA. 2011;108(18):7523-7528. doi:10.1073/pnas.1101748108.
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2010

Activation of mannan-binding lectin-associated serine proteases leads to generation of a fibrin clot

Gulla KC1, Gupta K, Krarup A, et al. Immunology. 2010;129(4):482-495. doi:10.1111/j.1365-2567.2009.03200.x.
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Other Publications:

PPARγ activation attenuates opioid consumption and modulates mesolimbic dopamine transmission

de Guglielmo G, Melis M, De Luca MA, et al. Neuropsychopharmacology. 2015;40(4):927-937. doi:10.1038/npp.2014.268.

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Selection of targeted mutants from a library of randomly mutagenized ES cells

Horie K, Gaitanaris G, Gragerov A. Methods Mol Biol. 2011;693:283-294. doi:10.1007/978-1-60761-974-1_17.

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An inducible and reversible mouse genetic rescue system

Zeng H, Horie K, Madisen L, et al. PLoS Genet. 2008;4(5):e1000069. doi:10.1371/journal.pgen.1000069.

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Neuromedin U receptor 2-deficient mice display differential responses in sensory perception, stress, and feeding

Zeng H, Gragerov A, Hohmann JG, et al. Mol Cell Biol. 2006;26(24):9352-9363.

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