Protocols are likely to be followed in wake of influential eye drug study

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Independent, rigorous, head-to-head studies are rarely conducted on drugs that remain of significant commercial importance to their manufacturers. So the findings of the Protocol T trial, which compared the efficacy of Eylea, Lucentis and Avastin at treating diabetic macular oedema (DME), are likely to be widely heeded by the ophthalmic community.

The financial world, meanwhile, has largely had its forecasts for this market confirmed: Eylea is set to continue growing strongly while Lucentis is considered a stagnating franchise, EvaluatePharma consensus shows (see table below). The biggest risk would appear to be further downgrades to numbers for Lucentis, given the clear backing for the use of compounded Avastin on cost grounds.

This backing was issued in an editorial that accompanied the full results of the study, published in the New England Journal of Medicine.

The authors concluded that in patients with visual acuity of 20/40 or better, Avastin should be considered first-line therapy, largely based on cost. Around three quarters of patients present with vision on this scale, they noted.

In these patients the study found no significant differences in terms of safety or efficacy among the drugs, which stands in stark contrast to their relative cost. Compounded Avastin costs $50 a shot, Lucentis $1,200 and Eylea $1,950.

Regeneron justifies the higher price because fewer shots are needed. Interestingly, however, the study did not entirely confirm this to be the case in DME – overall, Eylea was found to work better with the same number of administrations as Lucentis.

The editorial authors also concluded that, because Eylea promoted a significantly greater improvement in vision in patients with a visual acuity of 20/50 or worse, it should be considered first-line in these patients. Given a seeming equivalence between Avastin and Lucentis and the large difference in cost, the former could be considered an alternative treatment.

Winner and loser?

Commercially speaking, this is all likely to have the biggest impact on Lucentis, which has undoubtedly emerged a loser from this study. Not that this will come as a huge surprise to those watching the space – sales likely peaked for Roche and Novartis last year, forecasts suggest.

As the table below shows, some growth is expected in DME for the franchise in the coming years; for this to materialise both companies will have to work very hard to grow their share.

Demand for compounded Avastin is also unlikely to wane.

Regeneron, meanwhile, has much to celebrate. Sure, it might have seen its core market restricted to a quarter of the DME presenting population, but payers are going to have a hard time refusing to reimburse the drug for these patients.

Eylea also outperformed the competition on other clinically relevant measures, including decrease in retinal thickness and the requirement for laser photocoagulation post treatment. This will likely persuade a bigger pool of patients and their physicians that the drug is for them – assuming that they can pay.

Anti-VEGF antibodies in eye conditions
Proportion of sales by indication/sales
Product Company Markets Indication  2014 2020
Eylea Regeneron  US Wet AMD 86% 73%
Macular oedema 6% 17%
Retinal vein occlusion 8% 9%
Annual sales ($bn) 1.7 3.5
Eylea Bayer WW ex-US Wet AMD 81% 71%
Macular oedema 8% 15%
Retinal vein occlusion 11% 14%
Annual sales ($bn) 1.0 2.0
Lucentis Novartis WW ex-N. America Wet AMD 76% 74%
Macular oedema 17% 19%
Retinal vein occlusion 7% 8%
Annual sales ($bn) 2.4 2.1
Lucentis Roche N. America Wet AMD 63% 55%
Macular oedema 20% 26%
Retinal vein occlusion 17% 19%
Annual sales ($bn) 1.9 1.5
Total anti-VEGF market (includes Japan sales not split out) 6.2 9.6

To contact the writer of this story email Amy Brown in London at AmyB@epvantage.com or follow @AmyEPVantage on Twitter

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