FDA Roundup: The First Prosthetic Iris


This week, the FDA approved the first standalone prosthetic iris, granted priority review to a pediatric anti-epileptic and a postpartum depression drug, accepted another try from an opioid use disorder drug, and announced new plans against the opioid epidemic.

Hi, I’m Kevin Kunzmann, and welcome to MD Magazine’s weekly FDA Roundup. Let’s get to it.

This week the FDA approved the first standalone prosthetic iris for adults and children, indicated for patients whose iris is either completely missing or damaged. The CustomFlex Artificial Iris, a thin, foldable medical-grade silicone prosthetic that is customizable by size and eye color for each patient, has been indicated for patients who suffer from aniridia or other damage to the eye.

Eisai Inc. announced the Priority Review granted to the company’s antiepileptic drug Fycompa for monotherapy and adjunctive use for the treatment of partial-onset seizures with or without secondarily generalized seizures in pediatric patients aged 2 to 12 years old. The submitted application covers both the perampanel tablet and oral suspension formulations.

Priority Review was also granted to an intravenous medication that is looking to become the first indicated treatment of postpartum depression in women. Brexanolone IV formulation will be gauged under Priority Review with an action date of December 19, 2018.

After receiving a Complete Response Letter for investigative long-acting subcutaneous injection CAM2038 in late January, Braeburn Pharmaceuticals has announced its New Drug Application resubmission for the drug’s indication to treat patients with opioid use disorder, to be decided upon again in 30 days.

Lastly, the FDA announced an innovation challenge as part of its efforts to address the ongoing opioid epidemic in the United States, with the goal of inciting the development of new medical devices, diagnostic tests, and health technology. The challenge is part of the FDA’s current work to try to reduce the range of the opioid crisis and is in support of multiple overarching goals of the U.S. Department of Health and Human Services' Five-Point Strategy to Combat the Opioid Crisis.

For these stories and more, visit us at MDMag.com. This has been Kevin Kunzmann with your FDA Roundup, thank you for watching.

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