Drugs

CRL for Aldeyra’s Reproxalap for Dry Eye

FDA has issued a complete response letter to Aldeyra Therapeutics for its NDA for reproxalap to treat the signs and symptoms of dry eye disease. A company statement says the CRL indicated that while no safety or manufacturing issues were identified, the NDA “failed to demonstrate efficacy in adequate and well-controlled studies in treating ocular symptoms associated with dry eye.” The letter said that at least one additional study should be conducted to demonstrate a positive effect. FDA also reportedly identified concerns with data from the trial submitted with the NDA that may have affected study result interpretation, possibly due to methodological issues.

The company says it expects to announce top-line results from two ongoing trials in the second quarter. “Subject to positive results and discussions with FDA, Aldeyra intends to resubmit the NDA mid-year 2025,” it says.

Reproxalap is described as an investigational drug candidate being developed to treat dry eye disease and allergic conjunctivitis. It is a first-in-class small molecule modulator of RASP, which are elevated in ocular and systemic inflammatory diseases.

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