FDA Panel’s Vote Leaves ReSure Ophthalmic Sealant “Nearly There”

Ocular Therapeutix, developer of hydrogel based sealant technology for use in ophthalmic cases, has received a guarded nod from the FDA’s review panel.

Background

The FDA’s ophthalmic expert panel met as scheduled this week with a view to considering Ocular’s ReSure hydrogel sealant for marketing approval. The sealant, in common with hydrogels used in other areas of surgery, is intended to form an in situ “bandage” over incisions made in the eye’s cornea, in order to prevent leakage after, for example, cataract/Intraocular lens implant surgery.

The company already has CE mark approval for its product and filed for US PMA approval in February, a move which would give it access to the biggest market in the world.

The FDA will now review its expert panel report, and consider whether to approve the device/system for market.

What might feature in their deliberations are a few areas where the expert panel was not unanimous. They voted 9/1, with 1 abstention, that the ReSure Sealant is safe, 5/3, with 3 abstentions, that it is effective and 5/1, with 1 abstention, that its benefits outweigh its risks.

As subsequently reported, several panelists said that some “word-smithing” to the product’s proposed label would have changed their’ ‘no’ vote to a ‘yes’. That leaves the FDA itself a bit of wiggle room in the event that it decides to approve the product.