The US Food and Drug Administration has approved bevacizumab-vikg (LYTENAVA) for the treatment of neovascular age-related macular degeneration, also known as wet age-related macular degeneration, according to a press release from Outlook Therapeutics. Bob Jahr, chief executive officer of Outlook Therapeutics, said, “[P]hysicians now have access to a purpose-built ophthalmic formulation of bevacizumab designed specifically for intravitreal administration that delivers the manufacturing consistency, product quality, and regulatory oversight patients deserve.”
According to the company, LYTENAVA is supported by clinical evidence, validated manufacturing, approved labeling, comprehensive quality systems, and ongoing US Food and Drug Administration (FDA) regulatory oversight. Outlook Therapeutics also stated that it anticipates the approval will provide LYTENAVA with 12 years of Reference Product Exclusivity under the Biologics Price Competition and Innovation Act.
“The retina community has been waiting a long time for access to an FDA-approved, ophthalmic formulation of bevacizumab to treat patients suffering from wet AMD [age-related macular degeneration] in the United States,” said Firas M. Rahhal, MD, chairman of ophthalmology at Good Samaritan Hospital in Los Angeles.
LYTENAVA is a recombinant humanized immunoglobulin G1 monoclonal antibody specific for human vascular endothelial growth factor (VEGF). According to the press release, it binds all isoforms of VEGF-A and, by inhibiting VEGF-A, suppresses endothelial cell proliferation, neovascularization, and vascular permeability, processes that contribute to vision loss.
Outlook Therapeutics stated that it is executing the commercial launch of LYTENAVA through reimbursement support programs, patient assistance services, and support for physicians nationwide. The company expects the product to become available to eligible US patients before the end of 2026.
According to the prescribing information, LYTENAVA is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, and hypersensitivity to bevacizumab products or any ingredient in the formulation. The prescribing information identifies endophthalmitis, retinal detachment, and increased intraocular pressure as risks associated with intravitreal administration. It also advises that vascular endothelial growth factor inhibitors administered intravitreally may carry a risk of arterial thromboembolic events. The most common adverse reactions reported in clinical trials were conjunctival hemorrhage, eye pain, and vitreous floaters.
Source: Outlook Therapeutics