Securing label approval for wAMD will increase the confidence of ophthalmologists who are currently hesitant to use an off-label therapy. Credit: woff via Shutterstock.

On March 31, 2022, Outlook Therapeutics submitted a Biologics License Application (BLA) to the FDA for ONS-5010 (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wAMD). Bevacizumab is currently used as an off-label therapy, in the form of Avastin, for patients with wAMD. If ONS-5010 is approved, then there will be a number of factors that will determine its wider market penetration, the most crucial of which is pricing.

Winning a label approval for wAMD will increase the confidence of ophthalmologists who are currently hesitant to use an off-label therapy for various reasons, including the lack of a robust set of clinical trials data in support of this therapy for wAMD. There is also an element of risk associated with the preparation of Avastin from compounding pharmacies, although the practice is widely established and one that is commonly used by ophthalmologists for wAMD. In that sense, having a ready-to-use Avastin formulation is more appealing than one that needs to be prepared through multiple steps involving product aliquoting, handling, and distribution.

The pricing model associated with ONS-5010 is likely to be another factor that will be crucial for successful market penetration. Physicians interviewed by GlobalData were of the consensus that while a label approval for bevacizumab for use in patients with wAMD will be a positive step, the price point of the new therapy needs to be similar to off-label Avastin in order to see rapid uptake in the market. According to GlobalData’s report on AMD, published in January 2022, the average cost per treatment day for Avastin is $50.75 in the US. It will remain to be seen how Outlook Therapeutics will price ONS-5010 if the therapy receives approval.

Upon receiving FDA approval and its eventual launch, ONS-5010 will be entering a market that is saturated with anti-vascular endothelial growth factor (anti-VEGF) therapies for wAMD. While ONS-5010 is expected to compete directly with off-label Avastin, it is also worth noting that this therapy will face fierce competition from recently approved therapies such as Roche’s Vabysmo (faricimab) and Susvimo (ranibizumab, sustained release), both of which are set to differentiate themselves with a lower frequency of administration compared to current standards of care such as Eylea and Lucentis and even Avastin. Patients and ophthalmologists will no doubt prefer a therapy that needs to be administered less frequently but in the long run, there is likely to be a question on the part of healthcare service providers and insurance companies on how financially viable these newer therapies will be given that off-label Avastin is comparable to other anti-VEGF therapies in terms of its efficacy for wAMD but at a lower price. On that note, if Outlook Therapeutics goes on to win an FDA approval, it is likely that ONS-5010 will stand to win considerable patient share from off-label Avastin, and potentially from aforementioned anti-VEGF therapies, if its pricing model is favorable with healthcare service providers and insurance companies.

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