Physician Views: As off-label Avastin use threatens to increase in Europe, where next for wet AMD therapies?

Physician Views: As off-label Avastin use threatens to increase in Europe, where next for wet AMD therapies?

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Published on Jul 16, 2014

The market for wet age-related macular degeneration (AMD) therapies retains significant commercial opportunity, but also notable controversy.

The former is illustrated by the newest market entrant in this space - Regeneron Pharmaceuticals and Bayer's Eylea - which rapidly assumed blockbuster status just a year after launch. The latter is focused primarily on the widespread use of compounded Avastin (Roche's cancer product) in an off-label capacity as a much cheaper alternative to Roche and Novartis' market-leading AMD therapy Lucentis. Long established as a method to treat patients in the US, Italy and France have both recently approved use of off-label Avastin, suggesting that this practice could gain prominence in the EU.

The success of Eylea has demonstrated, however, that innovation still provides the opportunity to trump the much reduced cost of compounded Avastin (Regeneron's product is dosed less frequently than Avastin or Lucentis) and a number of AMD therapies that have moved into late-stage testing are among the most interesting in the industry pipeline.

These include Allergan's DARPin - which appears to be comparable, if not slightly superior, to Lucentis, but with a potential dosing frequency of once every three months (based on Phase II data) - and the combination of Ophthotech's Fovista - which combined with Lucentis demonstrated a statistically significant improvement over Lucentis monotherapy (again, based on Phase II data). See - ViewPoints: Novartis eyeing up longer-term access to US AMD market with licensing deal?

Furthermore, Lucentis has seen its growth rate reinvigorated by approval in the diabetic macular oedema (DME) setting, with progression of Eylea into this indication a potential key catalyst for future growth.

As the wet AMD market continues to evolve rapidly, FirstWord is this week polling US and EU5-based ophthalmologists and asking them...
  • How comfortable they are/would you be prescribing compounded Avastin as an alternative wet age-related macular degeneration (AMD) therapy to Lucentis or Eylea?
  • Which available wet AMD therapy has the strongest overall profile?
  • Based on their experience of the product in AMD, to what percentage of DME patients would you expect to prescribe Eylea 12 months after approval in this indication?
  • Assuming that similar data were provided in Phase III studies for Allergan's DARPin with once-every three months dosing, to what percentage of wet AMD patients they would expect to prescribe the product?
  • Assuming the combination of Ophthotech's anti-PDGF therapy Fovista and Lucentis replicated the statistically superior Phase II
  • performance it demonstrated versus Lucentis in Phase III studies, to what percentage of AMD patients they would expect to prescribe the combination?