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Panel member explains concerns about indications for use
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Some panel members abstained from voting or voted that ReSure Sealant had not been demonstrated to be safe and effective when used for the proposed indications for use, according to member Bennie H. Jeng, MD, MS.
“I think it was totally due to the way the [indications for use] was worded,” Jeng told Ocular Surgery News. “There was some controversy toward the end of the meeting about that. I don’t believe that the sponsor had a chance to address it like they probably wanted to in terms of justifying how they had written it.”
Jeng said he and some other panel members felt that the phrase “prevention of postoperative fluid egress” may suggest prophylactic use, when such a use was not expressly tested.
“That portion suggested that it could be used for prophylaxis, where their testing was only done in active leaks,” he said. “In truth, one would basically surmise that if it works in leaking cases, then it should work as prophylaxis for the prevention of leaks. But if you go by the straight wording, they didn’t specifically test for that.”
Jeng also expressed personal reservations about the phrase “cataract surgery or intraocular lens placement surgery,” which he said implies that ReSure Sealant is safe and effective for lens exchange cases.
“Exchanging an intraocular lens is actually more traumatic than doing just regular cataract surgery with intraocular lens implantation, so it may cause more disruption of the wound. That’s not accounted for,” he said.
The phrase should read “cataract surgery and intraocular lens placement surgery,” Jeng said.
Overall, Jeng said he and fellow members would probably have voted differently if Ocular Therapeutix had the opportunity to revise the indications for use.
“For the indication that they really meant or as we would have accepted it, I do believe that the overwhelming majority of people were very much in favor,” Jeng said. “Had that been worded the way that we would have wanted it to be clarified, then I’m positive that the overwhelming consensus would have been more positive.” – by Matt Hasson