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Age-Related Macular Degeneration (AMD): Update Bulletin [December 2016]

Product Code:
Publication Date:
December 2016

Gain new KOL insights on the latest events that have the potential to impact the treatment landscape of age-related macular degeneration (AMD). Topics covered include expert opinions on: Novartis and Ophthotech announcing negative topline results from two pivotal Phase III clinical studies evaluating the safety and efficacy of Fovista (pegpleranib) in combination with Lucentis (ranibizumab) for the treatment of neovascular age-related macular degeneration; Regeneron reporting negative top-line 12 week data from the Phase II CAPELLA study which is evaluating Eylea (aflibercept) co-formulated with rinucumab (an anti-platelet derived growth factor [PDGF] receptor monoclonal antibody; mAb) as a potential treatment of AMD; Ophthea presenting positive top-line Phase I/II data for OPT-302 at the European Society of Retina Specialists (EURETINA) Congress, in Copenhagen, Denmark; and Ocular Therapeutix announcing an agreement with Regeneron to develop a sustained release formulation of Eylea using the company’s first-in-class PEG hydrogel-based technology.

Business Questions

  • Have the failures of the Phase II CAPELLA and Phase III OPH1002 and OPH1003 studies signalled an end to the search for a PDGF targeting treatment for AMD, or will anti-PDGF become part of the future treatment algorithm?
  • How much of an impact has mechanism of action, formulation and patient selection had on the outcome of the Phase II CAPELLA and Phase III OPH1002 and OPH1003 studies?
  • What does the future hold for rinucumab and pegpleranib in light of these new data, and do KOLs believe any further development of the two products will be conducted?
  • Are KOLs excited about the data for OPT-302 as a potential treatment for AMD, or is it simply too early for KOLs to draw any meaningful conclusions?
  • Do KOLs have any concerns about OPT-302’s pan-vascular endothelial growth factor (VEGF) blocking mechanism of action, and what do KOLs think about the design of its Phase I/II study?
  • What are the key determinants of success for OPT-302 as a potential treatment for AMD; safety, efficacy, durability or all of the above?
  • Does sustained-release aflibercept have the potential to be a “game changer” in the treatment of AMD, or will concerns about safety, formulation and the impact on treatment practice relegate this product to later-lines of therapy?


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