Ranibizumab (Genentech)

Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025 April 08, 2025 -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union (EU) and the United Kingdom (UK) for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of wet AMD. The FDA has determined that the BLA is a Class 2 review, which results in a six-month review period from the date of resubmission. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025. ONS-5010, if approved, will be branded as LYTENAVA™ (bevacizumab-vikg) in the United States for the treatment of wet AMD and is expected to receive 12 years of regulatory exclusivity. “Our team has worked diligently to advance our development and regulatory strategies for ONS-5010 to get to this point and we are proud of the continued progress we have been able to achieve,” commented Lawrence Kenyon, Chief Financial Officer and Interim Chief Executive Officer of Outlook Therapeutics. “This BLA acceptance and PDUFA date are significant milestones in our continued mission to offer clinicians and their patients the first and only on-label, ophthalmic bevacizumab to treat wet AMD. We are committed to bringing an ophthalmic bevacizumab to market in the United States and are continuing our activities for potential commercialization.” The ONS-5010 BLA resubmission was based on the efficacy and safety demonstrated in NORSE EIGHT, as well as additional chemistry, manufacturing and controls (CMC) information requested by the FDA. As previously announced, following Type A meetings with the FDA in Q4 CY2023 to address the ONS-5010 Complete Response Letter (CRL), the FDA informed Outlook Therapeutics that, in order to meet the FDA’s requirement for a second adequate and well-controlled clinical trial of ONS-5010, it could conduct a non-inferiority study evaluating ONS-5010 versus ranibizumab in a 12 week study of treatment naïve patients with a primary efficacy endpoint at 8 weeks (NORSE EIGHT). Outlook Therapeutics believes that the complete data set for NORSE EIGHT and the additional CMC information in the BLA resubmission, combined with the data from the other NORSE clinical trials, provides the required evidence to support approval of the ONS-5010 BLA in the United States. ONS-5010 / LYTENAVA™ is an ophthalmic formulation of bevacizumab for the treatment of wet AMD. LYTENAVA™ (bevacizumab gamma) is 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. Bevacizumab-vikg (bevacizumab gamma in the EU and UK) is a recombinant humanized monoclonal antibody (mAb) 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. 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. Outlook Therapeutics is a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma), for the treatment of retina diseases, including wet AMD. LYTENAVA™ (bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics is working to initiate its commercial launch of LYTENAVA™ (bevacizumab gamma) in the EU and the UK as a treatment for wet AMD, expected in the second quarter of calendar 2025. In the United States, ONS-5010/LYTENAVA™ is investigational, and a BLA has been resubmitted to the FDA. If approved in the United States, ONS-5010/LYTENAVA™, would be the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD. The content above comes from the network. if any infringement, please contact us to modify.

Opthea has wasted no time in reaching out to investors to see whether it can avoid debts and additional charges being called in.\n Only a month ago, Opthea was making preparations for the potential launch of a new eye disease drug onto the market. Now, the candidate has failed to match Eylea in a phase 3 trial, leaving the Australian biotech to consider its own future.The drug in question is sozinibercept, an inhibitor of vascular endothelial growth factors (VEGFs) C and D. Atea had been evaluating a 2-mg dose of sozinibercept every four or eight weeks in combination with Regeneron’s blockbuster VEGF inhibitor Eylea in patients with wet age-related macular degeneration (AMD) in a late-stage study.Patients receiving the combination therapy every four weeks or eight weeks saw a mean change in best corrected visual acuity at Week 52 of 13.5 and 12.8 letters, respectively, while patients who received Eylea only saw a slightly higher improvement of 13.7 letters.As well as failing on this primary endpoint, there was “no numerical difference observed in the key secondary endpoints,” Opthea noted. The biotech has wasted no time in reaching out to investors to see whether it can avoid debts and additional charges being called in. It will also make a decision on the future of the Coast trial and the phase 3 Shore trial—which is assessing sozinibercept in combination with Novartis’ Lucentis and is due to read out this year.“At this stage, no decision has yet been taken with respect to either trial, including whether to discontinue activities for the COAST trial or accelerate and unmask the ShORe trial,” Opthea said in the March 24 release. “Discussions continue with the DFA investors to determine the most appropriate course of action.”With $113.8 million in the bank as of the end of February, “there remains material uncertainty as to Opthea\'s ability to continue as a going concern,” the company added. The biotech has halted trading of its stock on both the Australian and Nasdaq exchanges while it works out a plan.The phase 3 fail marks an abrupt change in fortunes for Opthea, which had been confident enough in sozinibercept’s success to start gearing up its manufacturing activities in preparation for a potential commercial launch of the drug in wet AMD.The company joined the Nasdaq via a $128 million IPO in 2020. Investment enthusiasm for sozinibercept was driven by a phase 2 trial in which the drug bested Lucentis in wet AMD as well as “observed evidence of improved clinical outcomes” in a phase 1b/2a study in combination with Eylea in patients with treatment-refractory diabetic macular edema.