DRUGS APPROVED FROM COMPLETED STUDIES

Below are some research studies that NORI has participated in that have received FDA Approval

Ozurdex

NORI participated in 1 large Ozurdex® BRVO and CRVO trial from 2004 to 2009

  • FDA approved for treatment of Macular Edema associated with Retinal Vein Occlusion June 2009

NORI has participated in 2 large Ozurdex® DME trials from 2004 to present

  • Ozurdex® has been submitted to the FDA for approval and is expected to be approved for treatment of DME in the near future

Jetrea

NORI has participated in 2 Jetrea/ocriplamin trials from 2007 to 2009

  • FDA approved for treatment of Vitreomacular Adhesion in October 2012

Eylea

NORI has participated in a total of 6 Wet AMD aflibercept trials from 2006 to present

  • FDA approved for treatment of Wet AMD November 2011

NORI has participated in 2 Diabetic Macular Edema aflibercept trials from 2008 to 2011

  • Expected to be FDA approved for treatment of DME in the near future

NORI has participated in 2 Diabetic Macular Edema aflibercept trials from 2008 to 2011

  • FDA approved for treatment of Macular Edema associated with CRVO in September 2012

Lucentis

NORI participated in a total of 9 Wet AMD ranibizumab trials beginning in 2003 until 2012

  • FDA approved for treatment of Wet AMD June 2006
  • Higher success profile than Macugen®
  • NORI was the only clinical research site in Southwest Florida that participated in the CATT study. CATT was a National Institute of Health/National Eye Institute study comparing Lucentis to Avastin. For more information about the CATT study, please visit www.nei.nih.gov/CATT

NORI participated in 1 large DME ranibizumab trial from 2007 until 2012

  • FDA approved for treatment of DME August 2012
  • Remains the ONLY FDA approved medication for the treatment of DME

NORI participated in 3 large Macular Edema/RVO ranibizumab trials from 2007 until 2012

  • FDA approved for treatment of Macular Edema associated with RVO in June 2010.

Macugen

  • FDA approved for Wet AMD December 2004
  • First FDA approved Anti-VEGF
  • NORI participated in 2 Wet AMD pegaptanib trials in 2005 & 2006

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Fort Myers

6901 International Center Boulevard
Fort Myers, FL 33912
(239) 939-4323(800) 282-8281
Fax: (239) 939-4712

Naples

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Naples, FL 34103-4596
(239) 263-3337(800) 282-8281
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Cape Coral, FL 33990
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Port Charlotte, FL 33952
(941) 627-4422(800) 282-8281
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Bonita Springs, FL 34135
(239) 939-4323(800) 282-8281
Fax: (239) 939-4712