Read-out of data from OphthoTech's Phase III Fovista programme should occur by year-end and could drive a shift in the treatment paradigm for wet age-related macular degeneration (AMD) if impressive mid-stage results can be replicated.
Boosting the efficacy of VEGF inhibitors – such as Regeneron Pharmaceuticals' Eylea and Novartis/Roche's Lucentis – by co-inhibiting the PDGF pathway has been touted as one way to improve on the efficacy of current standard of care in wet AMD. Fovista is the most advanced anti-PDGF product in development and OphthoTech has implemented an agnostic approach to late-stage study design; across two trials it is evaluating Fovista in combination with Lucentis, Eylea and off-label Avastin.
Expectation among key opinion leaders is high, boosted by positive data for Fovista in a sizeable Phase II study. However, for OphthoTech, the stakes have been raised by confirmation last week that a similar therapy being developed by Regeneron and Bayer – rinucumab – failed to meet its primary endpoint in a mid-stage study when combined with Eylea.
Defining the Phase III results as a key binary event for OphthoTech, it remains to be seen if Regeneron's setback has eliminated a competitor or predicts failure for Fovista in a larger study; at the very least it has planted doubt in the minds of OphthoTech shareholders, although a number of analysts have argued that mechanistically Fovista is sufficiently differentiated from rinucumab (ViewPoints: As Regeneron stumbles, all eyes on Ophthotech in AMD race).
With focus on Fovista sharpened as a result, our latest Physician Views poll reassesses the Phase II data and asks ophthalmologists a number of questions regarding how they may use the product, assuming it successfully reaches the market.
Specifically we are asking US and EU5-based ophthalmologists…
Pegpleranib (Fovista) is being developed as a combination therapy for use with a VEFG inhibitor (Lucentis, Eylea, off-label Avastin) for the treatment of wet AMD.
In a 449-patient, Phase II study, pegpleranib 1.5mg in combination with Lucentis significantly improved mean vision gain at 24 weeks, compared to Lucentis alone. Patients receiving the combination treatment gained a mean of 10.6 letters on the ETDRS chart, compared to 6.5 letters for those on Lucentis monotherapy (p=0.019; a 62 percent additional benefit). If these data were replicated in a Phase III study how impressive would you consider them to be?
Based on the assumption of positive Phase III data and approval, do you think the 'agnostic' late-stage study design (in one trial, pegpleranib is being combined with Lucentis and in another it is combined with Eylea or Avastin) will aid adoption of pegpleranib?
Yes – marginally so
Yes – moderately so
Yes – significantly so
If the Phase III data were to demonstrate higher efficacy for pegpleranib with one particular VEGF inhibitor therapy – how likely do you think it would be that you would adhere only to that specific combination when using pegpleranib?
Not likely – (i.e. very comfortable to interchange VEGF inhibitors in a future combination setting)
Extremely likely (i.e. not comfortable to interchange VEGF inhibitors in a future combination setting)
In a real-world setting (and considering efficacy seen in Phase II studies) how much of a barrier to adoption do you think the requirement to administer pegpleranib and a VEGF inhibitor in two separate intravitreal injections would be? Furthermore, it is recommended that the two therapies are administered 30 minutes apart.
Marginal barrier to adoption
Moderate barrier to adoption
Significant barrier to adoption
Very significant barrier to adoption
If approved, how would you most commonly expect pegpleranib to be used in the treatment of wet AMD?
Would not use
Primarily in treatment naïve patients only – consistent use of pegpleranib
In both treatment naïve patients and existing patients (receiving a VEGF) – consistent use of pegpleranib
Primarily in treatment naïve patients only – using pegpleranib as and when needed (i.e. as a top up therapy)
In both treatment naïve patients and existing patients (receiving a VEGF) – using pegpleranib as an when needed (i.e. as a top up therapy)
Other (please state)
Results and related analysis will be published for FirstWord Pharma PLUS subscribers to read, with the opportunity for non-FirstWord Pharma PLUS subscribers to purchase these findings. To be notified when poll results and analysis become available, please click here.
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