Next-generation calcineurin inhibitors for ophthalmic indications

Bibliography

• ROSENFELD PH, BROWN DM, HEIER JS et al.: Ranibizumab for neovascular age-related macular degeneration. N. Engl. J. Med. (2006) 355:1419-1431.
   PubMed Web of Science ®Google Scholar
• AVERY RL, PIERAMICI DJ, RABENA MD, CASTELLARIN AA, NASIR MAGIUST MJ: Intravitreal bevacizumab (avastin) for neovascular age-related macular degeneration. Ophthalmology (2006) 113:363-372.
   PubMed Web of Science ®Google Scholar
• SPAIDE RF, LAUD K, FINE HF et al.: Intravitreal bevacizumab treatment of choroidal neovascularization secondary to age-related macular degeneration. Retina (2006) 26:383-390.
   PubMed Web of Science ®Google Scholar
• BASHSHUR ZF, BAZARBACHI A, SCHAKAL A, HADDAD ZA, EL HAIBI CP, NOUREDDIN BN: Intravitreal bevacizumab for the management of choroidal neovascularization in age-related macular degeneration. Am. J. Ophthalmol. (2006) 142:1-9.
   PubMed Web of Science ®Google Scholar
• WENGER RM: Structures of cyclosporine and its metabolites. Transplant. Proc. (1990) 22:1104-1109.
   PubMed Web of Science ®Google Scholar
• DUMONT FJ: Cyclosporin A and tacrolimus (FK-506) immunosuppression through immunophilin-dependent inhibition of calcineurin function. In: Principles of Drug Development Transplantation Autoimmunity. Lieberman R, Mukherjee A (Eds), Chapman & Hall, New York, USA (1996) 1:175-205.
   Google Scholar
• SCHREIBER SL, CRABTREE GR: The mechanism of action of cyclosporin A and FK-506. Gr. Immunol. Today (1992) 13:136-142.
   PubMedGoogle Scholar
• CHO ML, CHO CS, MIN SY et al.: Cyclosporine inhibition of vascular endothelial growth factor production in rheumatoid synovial fibroblasts. Arthritis Rheum. (2002) 46:1202-1209.
   PubMed Web of Science ®Google Scholar
• HO S, CLIPSTONE N, TIMMERMANN L et al.: The mechanism of action of cyclosporin A and FK506. Clin. Immunol. Immunopathol. (1996) 80(3 Part 2):S40-S45.
   PubMedGoogle Scholar
• STALDER M, BIRSAN T, HUBBLE RW, PANIAGUA RT, MORRIS RE: In vivo evaluation of the novel calcineurin inhibitor ISATX247 in non-human primates. J. Heart Lung Transplant. (2003) 22:1343-1352.
   PubMed Web of Science ®Google Scholar
• HERNANDEZ GL, VOLPER OV, INIGUEZ MA et al.: Growth factor-mediated angiogenesis by cyclosporine A: roles of the nuclear factor of activated T cells and cyclooxygenase 2. J. Exp. Med. (2001) 193(5):607-620.
   PubMed Web of Science ®Google Scholar
• Neoral® product information. Physicians' Desk Reference. Thomson PDR, Montvale, USA (2007).
   Google Scholar
• VOLLENBROEKER B, KOCH JH, FOBKER M, SUWELACK B, HOHAGE H, MULLER U: Determination of cyclosporine and its metabolites in blood via HPLC-MS and correlation to clinically important parameters. Transplant. Proc. (2005) 37:1741-1744.
   PubMed Web of Science ®Google Scholar
• VITALE AT, RODRIQUEZ A, FOSTER CS: Low-dose cyclosporin A therapy in treating chronic, noninfectious uveitis. Ophthalmology (1996) 103:365-374.
   PubMed Web of Science ®Google Scholar
• ISHIOKA M, OHNO S, NAKAMURA S et al.: FK506 treatment of noninfectious uveitis. Am. J. Ophthalmol. (1994) 118:723-729.
   PubMed Web of Science ®Google Scholar
• SALL K, STEVENSON OD, MUNDORF TK, REIS BL: Two multicenter, randomized studies of the efficacy and safety of cyclosporine ophthalmic emulsion in moderate to severe dry eye disease. CsA Phase III study group. Ophthalmology (2000) 107:631-639.
   PubMed Web of Science ®Google Scholar
• BARBER LD, PFLUGFELDER SC, TAUBER J, FOULKS GN: Phase III safety evaluation of cyclosporine 0.1% ophthalmic emulsion administered twice daily to dry eye disease patients for up to 3 years. Ophthalmology (2005) 112:1790-1794.
   PubMed Web of Science ®Google Scholar
• PRICE MO, PRICE FW Jr: Efficacy of topical cyclosporine 0.05% for prevention of cornea transplant rejection episodes. Ophthalmology (2006) 113:1785-1790.
   PubMed Web of Science ®Google Scholar
• WHALLEY D, HUELS J, MCKENNA SP, VAN ASSCHE D: The benefit of pimecrolimus (Elidel, SDZ ASM 981) on parent's quality of life in the treatment of pediatric atopic dermatitis. Pediatrics (2002) 110:1133-1136.
   PubMed Web of Science ®Google Scholar
• GEORGE AJT, LARKIN DFP: Corneal transplantation: the forgotten graft. Am. J. Transplant. (2004) 4:679-685.
   Google Scholar
• MAYER K, REINHARD T, REIS A et al.: FK506 ointment 0.1 – a new therapeutic option for atopic blepharitis. Clinical trial with 14 patients. Klin. Monatsbl. Augenheilkd. (2001) 218:733-736.
   PubMed Web of Science ®Google Scholar
• RUBIN M, RAO SN: Efficacy of topical cyclosporine 0.05% in the treatment of posterior blepharitis. J. Ocul. Pharmacol. Ther. (2006) 22:47-53.
   PubMed Web of Science ®Google Scholar
• SEDDON JM, GEORGE S, ROSNER B, RIFAI N: Progression of age-related macular degeneration: prospective assessment of c-reactive protein, interleukin 6, and other cardiovascular biomarkers. Arch. Ophthalmol. (2005) 123:774-782.
   PubMed Web of Science ®Google Scholar
• RODRIGUES EB: Inflammation in dry-age-related macular degeneration. Ophthalmologica (2007) 221:143-152.
   PubMed Web of Science ®Google Scholar
• NEWELL FW, KRILL AE: Treatment of uveitis with azathioprine (Imuran). Trans. Ophthalmol. Soc. UK (1967) 87:499-511.
   PubMedGoogle Scholar
• ANDRASCH RH, PIROFSKY B, BURNS RP: Immunosuppressive therapy for severe chronic uveitis. Arch. Ophthalmol. (1978) 96:247-251.
   PubMed Web of Science ®Google Scholar
• YAZICI J, PAZARLI H, BARNES CG et al.: A controlled trial of azathioprine in Behçet's syndrome. N. Engl. J. Med. (1990) 322:281-285.
   PubMed Web of Science ®Google Scholar
• HOLZ FG, KRASTEL H, BREITBART A et al.: Low-dose methotrexate treatment in noninfectious uveitis resistant to corticosteroids. Ger. J. Ophthalmol. (1992) 1:142-144.
   PubMedGoogle Scholar
• SHAH SS, LOWDER CY, SCHMITT MA, WILKE WS, KOSMORSKY GS, MEISLER DM: Low-dose methotrexate therapy for ocular inflammatory disease. Ophthalmology (1992) 99:1419-1423.
   PubMed Web of Science ®Google Scholar
• DEV S, MCCALLUM RM, JAFFE GJ: Methotrexate treatment for sarcoid-associated panuveitis. Ophthalmology (1999) 106:111-118.
   PubMed Web of Science ®Google Scholar
• WALTON RC, NUSSENBLATT RB, WHITCUP SM: Cyclosporine therapy for severe sight-threatening uveitis in children and adolescents. Ophthalmology (1998) 105:2028-2034.
   PubMed Web of Science ®Google Scholar
• MASUDA K, NAKAJIMA A, URAYAMA A, NAKAE K, KOGURE M, INABA G: Double-masked trial of cyclosporine versus colchicines and long-term open study of cyclosporine in Behçet's disease. Lancet (1989) 1:1093-1096.
   PubMed Web of Science ®Google Scholar
• BUCKLEY CE, GILLS JP: Cyclophosphamide therapy of peripheral uveitis. Arch. Intern. Med. (1969) 124:29-35.
   PubMed Web of Science ®Google Scholar
• OZYAZGAN Y, YARDAKUL S, YAZICI H et al.: Low dose cyclosporine A versus pulsed cyclophosphamide in Behçet's syndrome: a single-masked trial. Br. J. Ophthalmol. (1992) 76:241-243.
   PubMed Web of Science ®Google Scholar
• ROSENBAUM JT: Treatment of severe refractory uveitis with intravenous cyclophosphamide. J. Rheumatol. (1994) 21:123-125.
   PubMed Web of Science ®Google Scholar
• MONDINO BJ, BROWN SI: Immunosuppressive therapy in ocular cicatricial pemphigoid. Am. J. Ophthalmol. (1983) 96:453-459.
   PubMed Web of Science ®Google Scholar
• MAMO JG, AZZAM SA: Treatment of Behçet's disease with chlorambucil. Arch. Ophthalmol. (1970) 84:446-450.
   PubMed Web of Science ®Google Scholar
• MAMO JG: Treatment of Behçet's disease with chlorambucil. A follow-up report. Arch. Ophthalmol. (1976) 94:580-583.
   PubMed Web of Science ®Google Scholar
• O'DUFFY JD, ROBERTSON DM, GOLDSTEIN NP: Chlorambucil in the treatment of uveitis and meningoencephalitis of Behçet's disease. Am. J. Med. (1984) 76:75-84.
   PubMed Web of Science ®Google Scholar
• ABDALLA MI, BAHGAT NOUR E: Long-lasting remission of Behçet's disease after chlorambucil therapy. Br. J. Ophthalmol. (1973) 57:706-711.
   PubMed Web of Science ®Google Scholar
• TESSLER HH, JENNINGS T: High-dose short-term chlorambucil for intractable sympathetic ophthalmia and Behçet's disease. Br. J. Ophthalmol. (1990) 74:353-357.
   PubMed Web of Science ®Google Scholar
• LARKIN G, LIGHTMAN S: Mycophenolate mofetil. A useful immunosuppressive in inflammatory eye disease. Ophthalmololgy (1999) 106:370-374.
   PubMed Web of Science ®Google Scholar
• KILMARTIN DJ, FORRESTER JV, DICK AD: Rescue therapy with mycophenolate mofetil in refractory uveitis. Lancet (1998) 352:35-36.
   PubMed Web of Science ®Google Scholar
• THORNE JE, JABS DA, QAZI FA et al.: Mycophenolate mofetil therapy for inflammatory eye disease. Ophthalmology (2005) 112:1472-1477.
   PubMed Web of Science ®Google Scholar
• NUSSENBLATT RB, PALESTINE AG, CHAN CC: Cyclosporine A therapy in the treatment of intraocular inflammatory disease resistant to systemic corticosteroids and cytotoxic agents. Am. J. Ophthalmol. (1983) 96:275-282.
   PubMed Web of Science ®Google Scholar
• NUSSENBLATT RB, PALESTINE AG, CHAN CC et al.: Randomized double-masked study of cyclosporine compared to prednisone in the treatment of endogenous uveitis. Am. J. Ophthalmol. (1991) 112:138-146.
   PubMed Web of Science ®Google Scholar
• MOCHIZUKI M, MASUDA K, SAKANE T: A clinical trial of FK06 in refractory uveitis. Am. J. Ophthalmol. (1993) 115:763-769.
   PubMed Web of Science ®Google Scholar
• KILMARTIN DJ, FORRESTER JV, DICK AD: Tacrolimus (FK506) in failed cyclosporine A therapy in endogenous posterior uveitis. Ocul. Immunol. Inflamm. (1998) 6:101-109.
   PubMed Web of Science ®Google Scholar
• SLOPER CM, POWELL RJ, DUA HS: Tacrolimus (FK506) in the treatment of posterior uveitis refractory to cyclosporine. Ophthalmology (1999) 106:723-728.
   PubMed Web of Science ®Google Scholar
• DE VRIES J, BAARSMA GC, ZALL MJ et al.: Cyclosporin in the treatment of severe chronic idiopathic uveitis. Br. J. Opthalmol. (1990) 74:344-349.
   PubMed Web of Science ®Google Scholar
• SAMSON CM, WAHEED N, BALTAZIS S, FOSTER CS: Methotrexate therapy for chronic noninfectious uveitis. Ophthalmology (2001) 108:1134-1139.
   PubMed Web of Science ®Google Scholar
• WILLIAMSON J, PATERSON RW, MCGAVIN DD et al.: Posterior subcapsular cataracts and glaucoma associated with long-term oral corticosteroid therapy. In patients with rheumatoid arthritis and related conditions. Br. J. Ophthalmol. (1969) 53:361-372.
   PubMed Web of Science ®Google Scholar
• SPAETH GL, RODRIGUES MM, WEINREB S: Steroid-induced glaucoma. A. Persistent elevation of intraocular pressure. B. Histopathological aspects. Trans. Am. Ophthalmol. Soc. (1977) 75:353-381.
   PubMedGoogle Scholar
• JAFFE GJ, MARTIN D, CALLANAN D et al.: Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: 34 week results of a multicenter randomized clinical study. Ophthalmology (2006) 113:1019-1026.
   PubMedGoogle Scholar
• SUMNEY BT, YOSIPOVITCH G: Prevention of osteoporosis associated with chronic glucocorticoid therapy. Arch. Dermatol. (2006) 142:82-90.
   PubMed Web of Science ®Google Scholar
• JABS DA, ROSENBAUM JT, FOSTER CS et al.: Guidelines for the use of immunosuppressive drugs in patients with ocular inflammatory disorders: recommendations of an expert panel. Am. J. Ophthalmol. (2000) 130:492-513.
   PubMed Web of Science ®Google Scholar
• JABS A, KARAMURSEL E: Immunosuppression for posterior uveitis. Retina (2005) 25:1-18.
   PubMed Web of Science ®Google Scholar
• BAGNIS CI, DU MONTCEL ST, BEAUFILS H et al.: Long-term renal effects of low-dose cyclosporine in uveitis-treated patients: follow-up study. J. Am. Soc. Nephrol. (2002) 13:2962-2968.
   PubMed Web of Science ®Google Scholar
• TOWLER HM, WHITING PH, FORRESTER JV: Combination low dose cyclosporin A and steroid therapy in chronic intraocular inflammation. Eye (1990) 4:514-520.
   PubMed Web of Science ®Google Scholar
• ASPESLET L, FREITAG D, TREPANIER D et al.: ISA(TX)247: a novel calcineurin inhibitor. Transplant. Proc. (2001) 33:1048-1051.
   PubMed Web of Science ®Google Scholar
• RAO SK, BASTI S, LIN A, IYER GK, SEETHALAKSHMI G, LAM DS: The itching, burning eye: diagnostic algorithm and management options. Compr. Ophthalmol. Update (2006) 7:157-167.
   PubMedGoogle Scholar
• PRICE MO, THOMPSON RW, PRICE FW: Risk factors for various causes of failure in initial corneal grafts. Arch. Ophthalmol. (2003) 121:1087-1092.
   PubMed Web of Science ®Google Scholar
• United Kingdom Transplant Support Service Authority: Renal Transplant Audit 1984 – 1993. Bristol, UK (1995):35-49.
   Google Scholar
• AMBATI J, AMBATI BK, YOO SH, IANCHULEV S, ADAMIS AP: Age-related macular degeneration: etiology, pathogenesis and therapeutic strategies: Survey Ophthalmol. (2003) 48:257-293.
   PubMed Web of Science ®Google Scholar
• HAGEMAN GS, ANDERSON DH, JOHNSON LV et al.: A common haplotype in the regulatory gene factor H [HF1/CFH] predisposes individuals to age-related macular degeneration. Proc. Natl. Acad. Sci. USA ((2005) 102:7227-7232.
   PubMed Web of Science ®Google Scholar
• COMER GM, CIULLA TA, HEIER JS, CRISWELL MH: Future pharmacological treatment options for nonexudative and exudative age-related macular degeneration. Expert Opin. Emerging Drugs (2005) 10(1):119-135.
   PubMedGoogle Scholar
• GRAGOUDAS ES, ADAMIS AP, CUNNINGHAM ET et al.: Pegaptanib for neovascular age-related macular degeneration. N. Engl. J. Med. (2004) 351:2805-2816.
   PubMed Web of Science ®Google Scholar
• BROWN DM, KAISER PK, MICHELS M et al.: Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N. Engl. J. Med. (2006) 355:1432-1444.
   PubMed Web of Science ®Google Scholar
• Data on file, Isotechnika, Inc., Edmonton, Canada.
   Google Scholar
• KIM H, CSAKY KG, GILGER BC et al.: Preclinical evaluation of a novel episcleral cyclosporine implant for ocular graft-versus-host disease. Invest. Ophthalmol. Vis. Sci. (2005) 46:655-662.
   PubMed Web of Science ®Google Scholar
• GREGORY CR, KYLES AE, BERNSTEEN L et al.: Compared with cyclosporine, ISATX247 significantly prolongs renal-allograft survival in a nonhuman primate model. Transplantation (2004) 78:681-685.
   PubMed Web of Science ®Google Scholar
• Data on file, Lux Biosciences, Jersey City, USA.
   Google Scholar
• NO AUTHORS: ISA247. Drugs R&D (2007) 8(2):103-112.
   Google Scholar
• ASPESLET L, FREITAG D, HUIZINGA RB et al.: Pharmacokinetics-pharmacodynamics and safety of trans-ISA247: a novel immunosuppressant. Proceedings of the 3rd International Congress on Immunosuppression, San Diego, USA (2004):150367 (Abstract).
   Google Scholar
• ABEL M, MULLER F, FREITAG D et al.: 3D structure of ISA247 correlates with improved cyclophilin binding and calcineurin inhibition. Proceedings of the 3rd International Congress on Immunosuppression, San Diego, USA (2004):150489 (Abstract).
   Google Scholar
• BIRSAN T, CAMBRIN C, FREITAG DG, YATSCOFF RW, MORRIS RE: The novel calcineurin inhibitor ISA247: a more potent immunosuppressant than cyclosporine in vitro. Transpl. Int. (2005) 17:767-771.
   PubMed Web of Science ®Google Scholar
• ABEL MD, ASPESLET LJ, FREITAG DG et al.: Preclinical efficacy of a novel calcineurin inhibitor: ISATX247. Proceedings of the AAPS: 2001 Annual Meeting and Exposition, Denver, USA (2001):T3757 (Abstract).
   Google Scholar
• CUNNINGHAM MA, LI Z, CHAN CC et al.: Subcutaneous injections of LX211 prevent and reverse experimental autoimmune uveoretinitis in rats. Proceedings of the Association for Research in Vision and Ophthalmology Annual Meeting, Fort Lauderdale, USA (6 – 10 May 2007):B730 (Poster).
   Google Scholar
• ABEL MD, ASPESLET LJ, FREITAG DG et al.: ISATX247: a novel calcineurin inhibitor with minimal renal toxicity. Am. J. Transplant. (2001) 1(Suppl. 1):1192 (Abstract).
   Google Scholar
• DUMONT FJ: ISAtx-247 (Isotechnika/Roche). Curr. Opin. Investig. Drugs (2004) 5:542-550.
   PubMedGoogle Scholar
• YATSCOFF RW, ABLE MD, ASPESLET LJ et al.: Pharmacokinetics of a novel calcineurin inhibitor – ISA247. Proceedings of the 7th International Congress of TDM-CT, Washington, DC, USA (2001):161 (Abstract).
   Google Scholar
• FREITAG D, MAYO P, ASPESLET L et al.: The novel immunosuppressant ISA247 demonstrates a different metabolic profile than cyclosporine A in vitro and in vivo. Proceedings of the World Transplant Congress, Boston, USA (22 – 27 July 2006):2434 (Abstract).
   Google Scholar
• ABEL MD, ASPESLET LJ, FOSTER RT et al.: ISA247: a new generation calcineurin inhibitor. Proceedings of the International Association of Therapeutic Drug Monitoring, Basel, Switzerland (7 – 11 September 2003):(Abstract.)
   Google Scholar
• WASEL N, GUPTA A, TOMI Z, PAPP K: Pharmacokinetics and pharmacodynamics of ISA247 in a Phase III randomized, multicenter, double-blind, placebo-controlled study. J. Am. Acad. Dermatol. (2006) 54(Suppl. 1):P36 (Abstract).
   Google Scholar
• YATSCOFF RW, BROSKI AP, ABEL MD et al.: Phase II trial results of ISATX247, a novel calcineurin inhibitor with a therapeutic window. Proceedings of the IXI International Congress of The Transplantation Society, Miami, USA (2002):0471 (Abstract).
   Google Scholar
• YATSCOFF RW, ABLE MD, ASPESLET LJ et al.: Phase II randomized, multicenter, open-label study of ISA247 and neoral in post-renal transplant patients. Proceedings of the American Transplant Congress, Washington, DC, USA (2003):1215 (Abstract).
   Google Scholar
• GUPTA A, TOMI Z, KUNYNETZ R et al.: Pharmacokinetics and pharmacodynamics of ISA247 in a Phase III, randomized, multicentre, double-blind, placebo-controlled study. Canadian Dermatology Association 81st Annual Conference, Winnipeg, Canada (27 June – 2 July 2006):(Abstract).
   Google Scholar
• BUSQUE S, LAFTAVI M, GASTON R et al.: ISA247: preliminary results of a Phase IIb multicentre, de novo renal transplant trial. American Transplant Congress, San Francisco, USA (6 May 2007):49 (Abstract).
   Google Scholar
• LANGLEY R, BISSONNETTE R, SEARLES G et al.: 24 Week results of a Phase III randomized, double-blind, multicentre, placebo-controlled study of ISA247 in plaque psoriasis Canadian Dermatology Association 81st Annual Conference, Winnipeg, Canada (27 June – 2 July 2006):(Abstract).
   Google Scholar
• GUENTHER L, BARBER K, VENDER R et al.: ISA247 remains a safe and efficacious agent after 48 weeks of continuous therapy: interim results of the SPIRIT extension study. Proceedings of the 15th Congress of the European Academy of Dermatology and Venereology, Rhodes, Greece (4 – 8 October 2006):950670 (Abstract).
   Google Scholar
• NGUYEN QD FOR THE LUMINATE (LUX UVEITIS MULTICENTER INVESTIGATION OF A NEW APPROACH TO TREATMENT) UVEITIS PROGRAM INVESTIGATOR GROUP: Phase II/III clinical trial of a novel calcineurin inhibitor, LX211, for the treatment of non-infectious uveitis. American Uveitis Socitey (AUS) Annual Meeting, Fort Lauderdale, USA (6 – 10 May 2007):(Abstract).
   Google Scholar
• PAPP K, LANGLEY R, BISSONNETTE R, ROSOPH L: A Phase III, randomized, multicenter, double-blind, placebo-controlled study of ISA247 in plaque psoriasis patients. J. Am. Acad. Dermatol. (2004) 54(Suppl. 1):P33 (Abstract).
   Google Scholar
• HODAK SP, BOUBARAK JB, RODRIGUEZ I, GELFAND MC, ALIJANI MR, TRACY CM: QT prolongation and near fatal cardiac arrhythmia after intravenous tacrolimus administration. Transplantation (1998) 66:535-537.
   PubMed Web of Science ®Google Scholar
• TURKMEN AY, BUNYAK B, HUSEYIN O et al.: The effect of calcineurin inhibitors on QT dispersion in renal transplant recipients. 5th International Conference on New Trends in Clinical and Experimental Immunosuppression, Geneva, Switzerland (2002):99 (Abstract).
   Google Scholar
• STAATZ CE, TETT SE: Clinical pharmacokinetics and pharmacodynamics of tacrolimus in solid organ transplantation. Clin. Pharmacokinet. (2004) 43:623-653.
   PubMed Web of Science ®Google Scholar
• KREMER JM, LEE JK: The safety and efficacy of the use of methotrexate in long-term therapy for rheumatoid arthritis. Arth. Rheum. (1986) 29:822-831.
   PubMed Web of Science ®Google Scholar
• KREMER JM, ALARCON GS, LIGHTFOOT RW et al.: Methotrexate for rheumatoid arthritis. Arth. Rheum. (1994) 37:316-328.
   PubMed Web of Science ®Google Scholar
• ROENIGK HH, AUERBACH R, MAIBACH et al.: Methotrexate in psoriasis: consensus conference. J. Am. Acad. Dermatol. (1998) 38:478-485.
   PubMed Web of Science ®Google Scholar