Drugs

Bausch & Lomb/Novaliq NDA for Dry Eye Disease

FDA has accepted a Bausch & Lomb and Novaliq NDA for NOV03 (perfluorohexyloctane), an eye drop therapy for treating the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). Perfluorohexyloctane is described as a water-free, non-steroidal, single-component preservative-free eye drop. The agency has set a user fee review action target data on 6/28/2023.

“NOV03 is distinct from anti-inflammatory and immunomodulatory agents, and, if approved, would be the first prescription eye drop to address excessive tear evaporation,” the companies say. “DED is one of the most common ocular surface disorders, with MGD as a major cause of development and progression, affecting approximately nine out of 10 people with DED.” The condition is said to be caused by a deficient tear film lipid layer that leads to increased tear evaporation.

The submission is based on data from two Phase 3 studies (GOBI and MOJAVE), both of which “demonstrated statistically significant improvement vs. control for both primary and key secondary sign and symptom endpoints as early as day 15 and through day 57,” the companies say.

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