Drugs

Eyenovia NDA for Pupil Dilation Drug

FDA has accepted for review an Eyenovia NDA for MydCombi (tropicamide 1% and phenylephrine 2.5%) ophthalmic solution, a fixed combination mydriatic (pupil dilation) agent for use in routine eye exams. “MydCombi was developed with the goal of providing a touchless fixed combination microdose formulation to improve the patient’s clinical experience,” the company says. It is delivered by Eyenovia’s proprietary Optejet dispenser, which is designed to deliver two mydriatic medications in a quick, touchless micro-mist application, it says.

The NDA submission was based on data from the MIST-1 and MIST-2 studies. In these two Phase 3 studies, MydCombi met the primary endpoints and was shown to be safe and effective for pharmacologic mydriasis. About 94% of treated eyes achieved 6mm or greater dilation at 35 minutes post-instillation, the company says.

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