Fi­nal­ly sat­is­fied with Oc­u­lar's man­u­fac­tur­ing set­up, FDA ap­proves eye drug/de­vice Dex­ten­za

Af­ter two FDA re­jec­tions that cul­mi­nat­ed in a man­age­ment shake-up and staff cuts, Oc­u­lar Ther­a­peu­tix’s $OCUL eye drug/de­vice Dex­ten­za has fi­nal­ly got the reg­u­la­to­ry nod, about a month ahead of the FDA’s ex­pect­ed de­ci­sion date.

Fol­low­ing oph­thalmic surgery, pa­tients are typ­i­cal­ly pre­scribed steroids via up to 70 top­i­cal eye drops to treat oc­u­lar pain. In lieu of this com­plex reg­i­men, Dex­ten­za of­fers a full course of post-sur­gi­cal steroid treat­ment with a one-time place­ment of an oph­thalmic in­sert that re­leas­es the cor­ti­cos­teroid dex­am­etha­sone for up to a month fol­low­ing in­ser­tion.

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