Outlook Therapeutics recently submitted a Biologics License Application to the US Food and Drug Administration (FDA) for ONS-5010 (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wAMD). If ONS-5010 is approved, the pricing of the therapy would be significant for its introduction into the wider market, says GlobalData, a leading data and analytics company.

AMD is associated with breakdown of the macular region of the retina that can cause significant vision loss. Among the different forms of AMD, only wAMD has approved treatment options. The standard of care for wAMD patients is anti-VEGF therapy, which can slow or inhibit the growth and leakage of blood vessels in the retina.

Vinie Varkey, Pharmaceutical Analyst at GlobalData, comments: “Winning a label approval for wAMD will increase the confidence of ophthalmologists who might be hesitant to use an off-label therapy for various reasons. However, 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 a rapid uptake in the market.”

According to GlobalData’s report ‘Age-Related Macular Degeneration – Global Drug Forecast and Market Analysis to 2028’, the average cost per treatment day for Avastin is $50.75 in the US. On the other hand, the average cost per treatment day for current standards of care that have received approval for wAMD are much higher, with Eylea standing at $1,850 and Lucentis at $1,950.

Varkey adds: “Upon receiving FDA approval and its eventual launch, ONS-5010 will be entering a market that is already saturated with anti-vascular endothelial growth factor (VEGF) therapies approved for wAMD, including Eylea (aflibercept), Lucentis (ranibizumab), Susvimo (ranibizumab sustained release formulation), Beovu (brolucizumab), and Vabysmo (faricimab).”

While ONS-5010 is anticipated to compete directly against 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 by the need for lesser frequency of administration compared to current standards of care such as Eylea and Lucentis and even Avastin.

Varkey concludes: “Patients and ophthalmologists will no doubt prefer a therapy that needs to be administered less frequently. However, 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 gain a considerable patient share, from off-label Avastin and potentially from aforementioned anti-VEGF therapies, if its pricing model is favourable with healthcare service providers and insurance companies.”