Ocular Therapeutix Inc.’s ReSure Sealant has been declared safe and effective for the management of clear corneal wound leaks following cataract surgery by the FDA’s ophthalmic devices panel.
Bedford, MA- Ocular Therapeutix Inc.’s ReSure Sealant has been declared safe and effective for the management of clear corneal wound leaks following cataract surgery by the FDA’s ophthalmic devices panel.
To make the determination, the panel reviewed data from a 488 patient-controlled, multicenter, randomized, prospective clinical trial of the medical device.
For the primary endpoint of prevention of wound leaks within the first 7 days post-operatively, the study found that the sealant demonstrated statistical superiority over sutures: Having successfully prevented would leaks in 95.9% of cases, compared with sutures at a rate of 65.9%.
Use of the sealant was also found to be associated with fewer adverse events when compared with suture and was well tolerated by patients.
“Prior to device application, nearly half of all clear corneal wounds spontaneously leaked in the trial, while the majority of remaining incisions leaked with minimal provocation,” said Amar Sawhney, president and chief executive officer of Ocular Therapeutix Inc. “Suturing has so far been the best definitive recourse for treating leaking wounds, however, in this trial the (sealant) was demonstrated to be superior to sutures.”
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