DRUGS APPROVED FROM COMPLETED STUDIES

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

Beovu

  • FDA approved for treatment of wet age-related macular degeneration in October 2019.
  • Beovu is the only anti-VEGF in wet AMD recommended to maintain eligible patients on up to three-month dosing intervals immediately after the loading phase with no compromise in efficacy

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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