“Ad campaigns are necessary for competition. But good PR educates people; that’s all it is.”
- Steve Jobs
In June, Novartis announced the positive phase 3 results of its pivotal trial comparing brolucizumab dosing vs on-label dosing of aflibercept in exudative AMD. Although the full details of the trial results are not yet available, the new drug appears to be noninferior to aflibercept, but with around half the patients obtaining the results with every-12-week dosing, compared to every-8-week dosing with aflibercept. While not revolutionary, it is most certainly evolutionary, as quarterly dosing would give our clinics a much-needed decompression, and patient acceptance would be high. Moreover, we will be able to extend the interval between treatments even further.
Many questions remain. For example, although the drugs were similar, were there more gainers or losers in one group? In the patients who were dosed at every-8-week intervals, was there any difference between brolucizumab and aflibercept? Were there OCT or FA differences? And, very importantly, was there a difference in safety profile?
There are also questions about how this will change the retina landscape. How much will it cost? As the fourth drug to market (this drug is not yet FDA approved), will Novartis take a page from Regeneron’s playbook and come in at a slightly lower price (like follow-up glaucoma drugs) or price it at a premium owing to the drug’s longevity? Will Genentech/Roche now take over ranibizumab sales worldwide, since Novartis now has its own anti-VEGF drug? Or, will Novartis market 2 drugs? Does a drug needed every 3 months trump the lower cost of bevacizumab, which needs to be delivered more frequently? Will the FDA allow the drug to be used more frequently than every 2 months, and how often is this needed? Do we need a study in the fashion of a DRCR.net Protocol T study in wet AMD to evaluate all the drugs in a PRN dosing regimen? It will be a very interesting time with this and abicipar pegol, another every-12-week anti-VEGF drug currently in phase 3 clinical testing around the corner.
At the end of the day, we are in for a PR blitz from the anti-VEGF companies. Some of this will be true, backed by sound clinical trial data. Some will be innuendo and rumor. Hopefully, to echo Steve Jobs’ sentiment, the campaigns will focus on the merits of each drug so physicians can make informed decisions. The real winners will be patients who may soon have another treatment option to prevent vision loss with as few interventions as possible. RP