With demand for cataract surgery growing as the Western world’s population ages, companies are rushing to offer devices such as replacement lenses or laser surgery systems. The Massachusetts firm Ocular Therapeutix has realised that the increase in these surgeries creates a demand in itself, and has developed a surgical sealant designed to aid the healing of incisions made during cataract or intraocular lens placement surgery.
On September 19 the ReSure sealant, the first of its kind for use in the eye, faces review by the FDA's ophthalmic devices panel. If it gets backing, Ocular Therapeutix will be a step closer to getting its first product into the US and tapping an extremely valuable market.
ReSure, a blue hydrogel that creates a temporary surface barrier to protect corneal incisions, is already CE marked and on sale in Europe. It turns from a liquid into a gel in situ on the ocular surface, without heating up or releasing toxic compounds. Its blue colour is intended to help surgeons see where it has been applied; the colour soon fades.
Ocular Therapeutix’s premarket approval (PMA) submission for the device, made six months ago, is seeking registration for two indications: intraoperative management of leaking clear corneal incisions and prevention of postoperative fluid egress after cataract or intraocular lens placement surgery.
Postoperative wound leaks are considered a major contributing factor to endophthalmitis, and prevention of these micro-leaks might cut the overall risk of the disease.
The PMA application was based on a randomised 488-patient trial comparing ReSure with sutured closure. The FDA’s panel will of course see the trial’s results – which is just as well because Ocular Therapeutix has not yet released them publicly.
Biocompatibility will be an important point; other eye surgery sealants have shown disappointing results here and Ocular Therapeutix will hope that the sealant’s hydrogel formulation will contribute to this. In terms of performance the speed at which patients’ vision stabilises after surgery is likely to be a key indicator.
The company has already convinced investors of ReSure’s bona fides. A series D round worth nearly $24m closed in June, with Baxter Ventures acquiring a minority equity stake.
As well as paying for the launch of ReSure, this cash will be used to advance Ocular Therapeutix’s other projects, chiefly its OTX-DP punctum plug technology. This is a more solid hydrogel formulation of drugs such as steroids or anti-infectives, inserted non-invasively through the punctum, a part of the tear duct. The plug delivers the drug to the ocular surface over several months, following cataract surgery.
But $24m will only get the company so far. Ocular Therapeutix needs the revenue stream that a US launch of ReSure would bring, and while it is hard to know how soon the device will be launched even if the panel gives it the nod, the company’s first US approval will be crucial to its future.