Drugs

Ocular Therapeutix Gets FDA Trial Protocol Agreement

Ocular Therapeutix says that it has received a written agreement from FDA regarding its registrational trial design under a Special Protocol Assessment for evaluating Axpaxli in the treatment of non-proliferative diabetic retinopathy (NPDR). “This formal agreement ensures direct FDA alignment with our proposed approach for NPDR and provides us with a clear regulatory path forward,” the company says.

Diabetic retinopathy is the leading cause of vision loss in working-age adults, yet fewer than 1% of the estimated 6.4 million Americans with NPDR currently receive treatment, according to Ocular Therapeutix. Many avoid current therapies because they require frequent injections, even before symptoms appear.

Axpaxli is described by the company as a bioresorbable intravitreal hydrogel containing axitinib, a tyrosine kinase inhibitor designed to block abnormal blood vessel growth. In the Phase 1 HELIOS trial, no NPDR patients who received a single Axpaxli injection experienced disease progression or vision-threatening complications at 48 weeks, compared to 25% of patients in the sham control arm, it says. Nearly 40% of the control group developed a vision-threatening complication.

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