Biologics

Outlook Therapeutics BLA Resubmitted for Wet AMD

FDA has accepted for review an Outlook Therapeutics BLA resubmission for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for treating wet age-related macular degeneration (wet AMD). The agency reportedly told the company that the submission is a complete, Class 1 response to an 8/27 complete response letter, and set a user fee review action target date of 12/31. ONS-5010, if approved, will be branded as Lytenava, according to the company.

The 8/27 FDA rejection, which was the second complete response letter sent to Outlook, cited insufficient evidence of effectiveness. The agency said it could not approve the application in its current form because the pivotal NORSE EIGHT trial failed to meet its primary efficacy endpoint, according to the company. While FDA acknowledged that the earlier NORSE TWO study did demonstrate effectiveness, regulators recommended in the letter that the company provide confirmatory evidence before the drug could be considered for approval

In 8/2023, FDA issued the original BLA a complete response letter that cited several chemistry, manufacturing and control (CMC) issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence, according to the company. It says the resubmission is based on the efficacy and safety demonstrated in the NORSE EIGHT clinical trial, as well as additional CMC information requested by the agency.

Bevacizumab is a recombinant humanized monoclonal antibody that “selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells,” Outlook says. “Following intravitreal injection, the binding of bevacizumab to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina.”

The company says Lytenava is being developed as the first approved ophthalmic formulation of bevacizumab in the U.S., offering an alternative to the widespread but off-label use of compounded Avastin for retinal diseases.

Wet AMD is a leading cause of vision loss in older adults, driven by abnormal blood vessel growth in the retina, the company says, adding that anti-VEGF therapies, delivered through intravitreal injections, have become the standard of care for treating the disease.

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