Drugs

Phase 3 Eye Study Terminated After Data Review

Eyenovia says it is terminating the Phase 3 CHAPERONE study evaluating its proprietary drug-device combination of low-dose atropine in the company’s Optejet dispensing platform as a potential treatment for pediatric progressive myopia. The action is based on an independent data review committee analysis that found the trial is not meeting its primary endpoint of a less than 0.5 diopter progression in visual acuity over three years, according to the company.

The committee reviewed the data from 252 evaluable patients and “found that the rate of myopia progression was not significantly different between the two active treatment arms (0.01% and 0.1% atropine ophthalmic metered spray) and placebo,” Eyenovia says. “In the safety analysis, all dosages and placebo appeared to be well-tolerated, with a mild and infrequent adverse event profile.”

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