Everything was looking so promising. The initial materials for the FDA adcom for ReSure, a sealant developed by Ocular Therapeutix to aid healing after cataract surgery, were pretty positive. The vote itself, taken yesterday, was less so.
ReSure is not dead quite yet. The vote was mixed on effectiveness but optimistic on safety and on benefits outweighing the risks, so there is still a chance that the product will be approved in the US. But Ocular Therapeutix will have been hoping for a slam-dunk: it needs ReSure's US revenue (Event – Ocular Therapeutix hopes for performing seal at adcom, August 5, 2013). The large number of abstentions on the panel will have done it no favours.
The FDA’s ophthalmic devices panel voted nine to one that ReSure was safe, with one of the panel members abstaining. Five voted in favour of its efficacy, with three against and three abstaining, and the overall risk/benefit vote was five to one in favour with five abstentions.
The abstentions point to a lack of enthusiasm about the product, but perhaps also to insufficient data – questions were already hovering regarding indications for use Ocular had proposed. The suggested indications did not specify a maximum incision length, but the 488-patient study on which the PMA application was based excluded patients with cuts longer than 3.5mm following their cataract surgery.
Secondly, the trial’s results had shown the sealant to be less effective in patients aged 80 or older; there was no age limitation on the proposed label. It is possible that if Ocular Therapeutix had been more specific about ReSure’s indications the vote would have been less equivocal.
While the vote was broadly positive, and it is possible that changes to the labelling could see the sealant approved by the FDA, it is worth bearing in mind that the agency has been increasingly stringent in recent months and years. The bar for supporting evidence appears to have been raised this year particularly, with the rate of first-time PMAs falling drastically compared with 2012 (US approvals of innovative devices halve, July 29, 2013).
Still, much of the FDA’s concern is with safety rather than efficacy – it wants to ensure medical devices are not harmful to patients, and therefore do not inspire recalls, scandals and lawsuits – so the lacklustre efficacy vote might not have damned ReSure.
With no other sealant approved for treating eye incisions, and cataract surgeries increasing from the 3.5 million procedures conducted in the US each year, the FDA will be under pressure to approve a product like this. This pressure could yet overcome its inclination to say no.