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Conforming punctum plug granted FDA approval

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GLENDORA, Calif. — A long-term intracanalicular plug has been granted marketing approval by the Food and Drug Administration, according to a press release from the product’s developer.

Oasis Medical said the Form Fit plug is composed of a hydrogel material designed to conform to fit all patients with a single size. When it contacts tear film, it “expands into a soft, pliable, gelatinous material” that takes about 10 minutes to completely hydrate and fill the vertical canalicular cavity, according to the press release.

The Form Fit is preloaded on an inserter, according to Oasis. The dry plug measures 3 mm in both length and diameter and can expand to 20 times its original size, according to the press release.

The Form Fit has also received European marketing approval, the company said.