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.
Medical and Scientific Publications
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Alternative drug delivery for patients undergoing cataract surgery as demonstrated in a canine model
Waterbury LD. J Ocul Pharmacol Ther. 2018;34:154-160.
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.
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.
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.
Importance of pupil dilation for cataract surgery
Mamalis N. J Cataract Refract Surg. 2017;43(5):583-584.
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.
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.
The clinical utility of new combination phenylephrine/ketorolac injection in cataract surgery
Lawuyi LE, Gurbaxani A. Clin Ophthalmology. 2015;9:1249-1254.
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.
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.
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.
Narsoplimab (OMS721) Publications:
Narsoplimab is an investigational product not approved by any regulatory agency.
2021
Lectin pathway mediates complement activation by SARS-CoV-2 proteins
Narsoplimab (OMS721) treatment contributes to improvements in organ function in adult patients with high-risk transplant-associated thrombotic microangiopathy
Narsoplimab (OMS721), a MASP-2 inhibitor, for the treatment of adult hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA): Subgroup analyses
Clinical pharmacology and population pharmacokinetic/pharmacodynamic modeling of lectin pathway inhibition by narsoplimab (OMS721)
In acute HSCT/BMT-TMA the activation of the lectin pathway induces C5b-9 formation on endothelial cells and favors microvascular thrombosis
Narsoplimab (OMS721), a MASP-2 inhibitor, for the treatment of adult hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA)
MASP2 levels are elevated in thrombotic microangiopathies: association with microvascular endothelial cell injury and suppression by anti-MASP2 antibody narsoplimab
Elhadad S, Chapin J, Copertino D, Van Besien K, Ahamed J, Laurence J. Clin Exp Immunol. 2021;203(1):96-104.
2020
Development of pharmacodynamic assays to assess ex vivo MASP-2 inhibition and their use to characterize the pharmacodynamics of narsoplimab (OMS721) in humans and monkeys
Endothelial injury and thrombotic microangiopathy in COVID-19: Treatment with the lectin-pathway inhibitor narsoplimab
Safety, tolerability, and effect of narsoplimab (OMS721), a novel MASP-2 inhibitor for the treatment of IgA nephropathy
Inhibition of the lectin pathway of the complement system as a novel approach in the management of IgA vasculitis-associated nephritis
Narsoplimab (OMS721) for the treatment of adult hematopoietic stem cell transplant-associated thrombotic microangiopathy
MASP-2 inhibition as a potential strategy for the management of IgA nephropathy
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
Absence of the lectin activation pathway of complement ameliorates proteinuria-induced renal injury
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, 2019; Budapest, HU.
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.
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.
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.
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.
Effective treatment of GvHD-associated transplant-associated microangiopathy with a novel inhibitor of the lectin pathway of complement
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.
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.
Resolution of acute kidney injury secondary to TA-TMA by the anti-MASP-2 monoclonal antibody OMS721 in a pediatric HSCT recipient
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.
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
2012
The lectin pathway of complement activation is a critical component of the innate immune response to pneumococcal infection
2011
Targeting of mannan-binding lectin-associated serine protease-2 confers protection from myocardial and gastrointestinal ischemia/reperfusion injury
2010
Activation of mannan-binding lectin-associated serine proteases leads to generation of a fibrin clot
Other Publications:
Selective inhibition of phosphodiesterase 7 enzymes reduces motivation for nicotine use through modulation of mesolimbic dopaminergic transmission
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.
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.
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.
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.
