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FDA Approves LYTENAVA as First Ophthalmic Bevacizumab for Wet AMD With 12-Year Exclusivity Outlook Therapeutics announced that the FDA has approved LYTENAVA (bevacizumab-vikg) as the first and only FDA-approved ophthalmic bevacizumab for treating wet age-related macular degeneration (wet AMD) in the U.S., with an anticipated 12 years of market exclusivity.
The company is targeting the nearly US$8.5b U.S. retina market and is launching a new commercial franchise around LYTENAVA, with plans aimed at broad patient access and support nationwide.
Outlook Therapeutics’ stock last traded at US$1.41, with a very large 90-day return of roughly 7x, highlighting how sensitive the share price has been to developments around LYTENAVA.
This approval turns Outlook Therapeutics from a pure development story into a commercial-stage ophthalmology business. However, investors still need clarity on pricing, reimbursement, uptake versus existing wet AMD therapies, and the costs of building and maintaining a national sales and support infrastructure. Announcement • Jul 25
Outlook Therapeutics Announces LYTENAVA FDA Approval as the First and Only FDA-Approved Ophthalmic Bevacizumab for the Treatment of Wet Amd Outlook Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved LYTENAVA (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (nAMD), commonly known as wet AMD. The approval establishes LYTENAVA as the first and only FDA-approved ophthalmic formulation of bevacizumab for the treatment of wet AMD in the United States. Retina specialists and patients have access to an FDA-approved ophthalmic bevacizumab developed specifically for the eye and supported by rigorous clinical evidence, validated manufacturing, approved labeling, comprehensive quality systems, and ongoing FDA regulatory oversight. The Company anticipates that the approval will provide LYTENAVA with 12 years of Reference Product Exclusivity under the Biologics Price Competition and Innovation Act (BPCIA). Bevacizumab already accounts for the majority of first-line anti-VEGF treatment in wet AMD. Wet AMD is a chronic, progressive retinal disease and one of the leading causes of severe vision loss among older adults worldwide. Patients often require treatment over many years to preserve vision, making manufacturing consistency, product quality, and long-term reliability especially important throughout treatment. LYTENAVA enters one of the world's largest ophthalmology markets. The U.S. anti-VEGF retina market is estimated at approximately $8.5 billion annually, with millions of intravitreal injections administered every year. The Company is executing the commercial launch of LYTENAVA, including expanding reimbursement and patient support access, building an industry-leading, specialized retina commercial organization, supporting physicians nationwide, and establishing LYTENAVA as the trusted FDA-approved ophthalmic bevacizumab across the United States. Outlook Therapeutics expects to make LYTENAVA available to eligible patients in the United States before year-end. The Company is committed to providing broad patient access support services through comprehensive reimbursement and patient assistance programs designed to help physicians integrate LYTENAVA into routine clinical practice for wet AMD. LYTENAVA is an ophthalmic formulation of bevacizumab produced in the United States for the treatment of wet AMD. In the United States, ONS-5010/LYTENAVA (bevacizumab-vikg) is the first ophthalmic formulation approved by the FDA. LYTENAVA (bevacizumab gamma) is also the subject of a centralized Marketing Authorization granted by the European Commission in the EU and Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD. In certain European Union Member States, LYTENAVA must receive pricing and reimbursement approval before it can be sold. Bevacizumab-vikg (bevacizumab gamma in the EU and UK) is a recombinant humanized IgG1 monoclonal antibody specific for human vascular endothelial growth factor (VEGF). Bevacizumab binds VEGF and prevents the interaction of VEGF to its receptors (Flt-1 and KDR) on the surface of endothelial cells. LYTENAVA binds to all isoforms of VEGF-A, thereby preventing interaction with receptors VEGFR-1 and VEGFR-2. By inhibiting VEGF-A, LYTENAVA suppresses endothelial cell proliferation, neovascularization, and vascular permeability. Inhibition of such activity targets a pathophysiologic process that contributes to vision loss. LYTENAVA (bevacizumab-vikg) is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (nAMD). LYTENAVA is contraindicated in patients with ocular or periocular infections, in patients with active intraocular inflammation, and in patients with a known hypersensitivity to bevacizumab products or any of the ingredients in LYTENAVA. Hypersensitivity reactions may manifest as severe intraocular inflammation. Intravitreal injections have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering LYTENAVA. In addition, patients should be monitored following the injection to permit early treatment should an infection occur. Increases in intraocular pressure have been noted post-injection (up to 60 minutes) while being treated with LYTENAVA. Monitor intraocular pressure prior to and following intravitreal injection with LYTENAVA and manage appropriately. Although there was a low rate of arterial thromboembolic events (ATEs) observed in the LYTENAVA clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). The most common adverse reaction (=1%) reported in patients receiving LYTENAVA was conjunctival hemorrhage (4%), eye pain (2%), and vitreous floaters (2%). These are not all the possible side effects of LYTENAVA. Announcement • Jul 04
Outlook Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $5 million. Outlook Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $5 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 8,539,709
Price\Range: $0.5855
Transaction Features: Registered Direct Offering 
