Devices

Eyenovia ‘Complete Response’ Related to Genus Decision

Eyenovia has received a complete response letter on its NDA for MydCombi (tropicamide and phenylephrine), indicated for in-office pupil dilation, because the agency had reclassified the drug as a drug-device combination product. The reclassification was prompted by FDA’s recent court loss (see earlier story) in Genus Medical Technologies, LLC v. FDA., according to the company.

In August, FDA announced it was implementing an appeals court decision affirming a district court ruling that it is not afforded discretion when a combination product meets the definition of both a device and a drug. The notice provided information about the way in which impacted products should be transitioned from drug to device status.

The Mydcombi NDA was filed in March as a drug after FDA determined that an accompanying eye dropper would not make it a combination product. Eyenovia says it will provide in early 2022 additional information to the agency as requested in the letter to meet the new requirements the Genus decision creates.

The NDA was based on data from the MIST-1 and MIST-2 studies. They showed that about 94% of treated eyes achieved 6 mm or greater dilation at 35 minutes post-instillation, according to the company. Adverse events were infrequent, with fewer than 1% of patients reporting blurred vision, reduced acuity, photophobia or instillation site pain.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome