Outlook Therapeutics® Announces Acceptance of Biologics License Application by U.S. FDA for ONS-5010 as a Treatment for Wet AMD
ISELIN, N.J., April 08, 2025 (GLOBE NEWSWIRE) -- 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.
About ONS-5010 / LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma)
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.
In the United States, ONS-5010 / LYTENAVA™ (bevacizumab-vikg) is investigational.
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.
About Outlook Therapeutics, Inc.
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.
Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical facts are 'forward-looking statements,' including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as 'anticipate,' 'believe,' 'continue,' 'expect,' 'may,' 'plan,' 'potential,' 'will,' or 'would' the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include, among others, Outlook Therapeutics' ability to remediate or otherwise resolve deficiencies identified in the CRL issued by the FDA in the resubmitted BLA, expectations concerning decisions of regulatory bodies and the timing thereof, including the PDFUA review goal date, expectations concerning the therapeutic potential of LYTENAVA™ as a treatment of wet AMD, ONS-5010/LYTENAVA™'s potential as the first FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal indications, including wet AMD, in the United States, Outlook Therapeutics' plans for commercial launch of LYTENAVA™ in the UK and EU and timing thereof, Outlook Therapeutics' commercialization strategy, and other statements that are not historical fact. Although Outlook Therapeutics believes that it has a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting Outlook Therapeutics and are subject to risks, uncertainties and factors relating to its operations and business environment, all of which are difficult to predict and many of which are beyond its control. These risk factors include those risks associated with developing and commercializing pharmaceutical product candidates, risks of conducting clinical trials and risks in obtaining necessary regulatory approvals, the content and timing of decisions by regulatory bodies, the sufficiency of Outlook Therapeutics' resources, as well as those risks detailed in Outlook Therapeutics' filings with the Securities and Exchange Commission (SEC), including the Annual Report on Form 10-K for the fiscal year ended September 30, 2024, filed with the SEC on December 27, 2024, and future quarterly reports Outlook Therapeutics files with the SEC, which include uncertainty of market conditions and future impacts related to macroeconomic factors, including as a result of the ongoing overseas conflicts, high interest rates, inflation and potential future bank failures on the global business environment. These risks may cause actual results to differ materially from those expressed or implied by forward-looking statements in this press release. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Outlook Therapeutics does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.
Jenene Thomas
JTC Team, LLC
T: 908.824.0775
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
CNBC
4 hours ago
- CNBC
More stock market records, more trade deals, more trade talks — plus, lots of earnings
The S & P 500 rose every day this past week as trade deals, both in the works and announced, lent support to the market. The index heads into the final stretch of a strong July at record highs. For the week, the S & P 500 gained nearly 1.5%. The Nasdaq did not go wire to wire in the green this week, but it did rise 1%, closing at another record high. Ahead of the last trading day of the month on Thursday, the S & P 500 was up almost 3% for July, while the Nasdaq jumped 3.6%. The best session of the week came on Wednesday after President Donald Trump announced the night before what he called a "massive" trade agreement with Japan ahead of the Aug. 1 deadline. The deal settled on a 15% tariff on goods entering the United States from Japan, including automobiles. In exchange, Japan will invest $550 billion in America and open its market to more imports from the U.S. The trade focus now shifts to China and the European Union. Next week, Treasury Secretary Scott Bessent travels to Stockholm for talks with Chinese officials about extending the negotiating window for a trade deal. Regarding the EU, Trump said Friday he sees only a "50-50 chance" of a deal with the trading bloc. The president plans to meet with EU officials in Scotland on Sunday. .SPX .IXIC 5D mountain S & P 500 and Nasdaq 5-day performance The other big news of this past week was Trump's trip to the Federal Reserve on Thursday. He toured the central bank renovation site with Fed Chairman Jerome Powell. They spoke with reporters and had an uncomfortable moment over renovation costs. Trump signaled that he's no longer considering firing Powell. The president told reporters Friday that Powell and he had a "good meeting" about interest rates, and he believes the Fed will start cutting them. Powell has kept rates steady since December 2024, saying central bankers need more time to see how finalized tariffs will impact inflation. On the economy, the June existing home sales report was released on Wednesday, followed by June new home sales on Thursday. While sales of both were slower than expected, the reports diverged when it came to prices. The median price of a previously owned home sold in June was $435,300, up year over year and the 24th consecutive month of annual increases, according to the National Association of Realtors. However, government data showed the median sales price of new homes sold last month was $401,800 — below May and below year-ago levels. Watching housing price trends is important because it can give us signals on where shelter costs might be headed, which have been a key factor keeping overall inflation elevated. Second quarter earnings season has kicked into full gear, with results thus far coming in better than expected. According to FactSet, a third of the S & P 500 companies have already reported, with 80% of those delivering upside surprises to both sales and earnings expectations. Within the Club portfolio, we heard from Danaher, GE Vernova, Capital One, Honeywell, and Dover. Talk about a blowout. GE Vernova came into the quarterly print near all-time highs, setting a high bar of expectations, which it easily hopped over. The stock was rewarded with record highs and was our top performer of the week, with 12% gains. Shares have nearly doubled in 2025 versus the S & P 500's 8.6% advance this year. GE Vernova on Wednesday reported strong order growth and robust EBITDA margin expansion. EBITDA stands for earnings before interest, taxes, depreciation and amortization. Strong backlog growth also gives us confidence that end market demand remains healthy. "This era of accelerated electrification is driving unprecedented investments in reliable power, grid infrastructure, and decarbonization solutions," CEO Scott Strazik said on the post-earnings call. Danaher on Tuesday delivered a strong set of results, albeit against relatively low expectations. The company did outpace expectations on the top and bottom lines, thanks to strength in all key operating segments. While Chinese sales in biotechnology and life sciences grew, the positive numbers were overshadowed by sustained weakness in diagnostics due to the countries volume-based procurement program. The quarter was enough to spark a relief rally and keep us in the name. Danaher was our second-best performer this week, rising 8%. Despite a good week, the stock was still down 10.5% year to date. Capital One delivered a noisy quarter on Tuesday due to the Discover integration. While shares were among our losers this week, down 2.5%, they have been on a roll, up more than 19% year to date. We saw enough the quarter to reaffirm our view that there will be some serious long-term benefits resulting from the acquisition and its payment network. Capital One is one of only two banks in the world with their own credit card network, the other being American Express. We will look for the company to leverage that edge into earnings growth and for the stock to be rewarded for it with a higher multiple as the integration progresses and management executes on their game plan. We were surprised by Thursday's more than 4% stock drop on Dover 's earnings. In addition to a top and bottom-line beat, the company reported a record adjusted segment EBITDA margin, an acceleration in bookings that provides visibility into the future. It also outlined several growth and productivity investments to support long-term growth. Compounding the strong results, management raised its full-year outlook on both revenue growth and adjusted earnings per share. For the week, Dover lost about 1%. Like Dover, Honeywell stock was also dinged after it reported Thursday morning, despite the results coming in largely better than expected. Shares were our worst performer of the week, down 5.2%. While there was some weakness in aerospace and in segment margin performance, we were satisfied with the explanation provided by management on the call and believe the weakness provides a buying opportunity ahead of what we think will be a value-creating breakup into three separate operating companies. The split will start in the fourth quarter of this year, when management spins off the advanced materials business, and continue in 2026 with the separation of aerospace, which will leave the automation business as the third public company. In the week ahead, we will get seven more Club name earnings, including Amazon , Apple , Meta Platforms , and Microsoft . (See here for a full list of the stocks in Jim Cramer's Charitable Trust.) As a subscriber to the CNBC Investing Club with Jim Cramer, you will receive a trade alert before Jim makes a trade. Jim waits 45 minutes after sending a trade alert before buying or selling a stock in his charitable trust's portfolio. If Jim has talked about a stock on CNBC TV, he waits 72 hours after issuing the trade alert before executing the trade. THE ABOVE INVESTING CLUB INFORMATION IS SUBJECT TO OUR TERMS AND CONDITIONS AND PRIVACY POLICY , TOGETHER WITH OUR DISCLAIMER . NO FIDUCIARY OBLIGATION OR DUTY EXISTS, OR IS CREATED, BY VIRTUE OF YOUR RECEIPT OF ANY INFORMATION PROVIDED IN CONNECTION WITH THE INVESTING CLUB. NO SPECIFIC OUTCOME OR PROFIT IS GUARANTEED.
UPI
4 hours ago
- UPI
Trump delivers immigration message on Scotland visit
1 of 3 | President Donald Trump played golf in Scotland Saturday morning, teeing it up at his Trump Turnberry golf resort ahead of meetings with European lawmakers and delivering a message after leaving the White House on Friday (pictured). Photo by Will Oliver/UPI | License Photo July 26 (UPI) -- President Donald Trump played golf in Scotland Saturday morning, teeing it up at his Trump Turnberry golf resort ahead of meetings with European lawmakers and delivering a message. "I say two things to Europe: Stop the windmills. You're ruining your countries. I really mean it, it's so sad. You fly over and you see these windmills all over the place, ruining your beautiful fields and valleys and killing your birds," Trump told reporters after arriving on Friday. "On immigration, you better get your act together. You're not going to have Europe any more," he said. Trump is scheduled to discuss trade during a Monday meeting with British Prime Minister Keir Starmer and Scottish First Minister John Swinney. He is also expected to meet with European Commission president Ursula von der Leyen during the four-day visit to Scotland. The delegation will start arriving Saturday and include European trade commissioner Maros Sefcovic, as well as von der Leyen, who Trump referred to as a "highly respected woman." U.S. officials and their EU counterparts are continuing attempts to reach a deal before an Aug. 1 deadline that will see 30% reciprocal tariffs take effect on all EU member states. The United States and Britain reached a deal in June on tariffs between the two countries, although Trump and Starmer were expected to iron out details during their meeting. Protestors demonstrated against Trump's visit in both Edinburgh and Aberdeen Saturday morning, including outside the Trump-owned golf course. He will also visit another of his privately-owned courses, Trump International Scotland in Aberdeenshire, during the trip. "We are really excited, across this whole weekend, there's so many campaign groups turning out in the streets, taking in action in their communities or at rallies like this. It's kind of like a carnival of resistance," demonstrator Anita Bhadani told the BBC outside of the U.S. Consulate General's office in Edinburgh Saturday, after helping to organize the Stop Trump Coalition. The coalition said its purpose is to "defeat the politics of Trumpism, and to promote an alternative, democratic vision of the world based on peace, social justice and international cooperation."
Newsweek
5 hours ago
- Newsweek
FDA Issues Highest Risk Warning For Cheeseburger Recall
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. A brand of cheeseburgers is being recalled due to undeclared allergens. Sheehan Brothers Vending issued a voluntary recall for its Cheeseburgers, which were distributed across three states, due to undeclared sesame. As a result, the Food and Drug Administration (FDA) has classified the recall as a Class I health risk, the most serious type of recall. Why It Matters According to the FDA, millions of people in the U.S. have food allergies or food sensitivities. Food sensitivities can range from mild reactions to potentially life-threatening symptoms. The agency recognizes nine major food allergens: milk, eggs, sesame, fish, tree nuts, crustacean shellfish, peanuts, wheat and soybeans. File photo dated 09/07/14 of a generic stock photo of a pile of cheeseburgers and french fries. File photo dated 09/07/14 of a generic stock photo of a pile of cheeseburgers and french fries. Press Association/AP What To Know As well as the cheeseburgers, the company is also recalling its Spicy Chicken Sandwich, Italian Mini Subs, Pepperoni Pizza Sub, Chili Cheese Coney and BBQ Riblet with coleslaw due to undeclared sesame. All the products have been issued a Class I health risk. A Class I health risk, as defined by the FDA, is issued when there is a reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death. This designation signals that the product poses an immediate danger to public health and requires urgent attention from both consumers and health professionals. The affected products were distributed in Indiana, Kentucky, and Ohio, specifically through Micro Markets and vending machines located throughout all of Ohio, northern Kentucky, and eastern Indiana. They were available for purchase between July 2 and July 8, 2025. The issue was identified during a routine inspection conducted by the Ohio Department of Agriculture. While no illnesses have been reported in connection with the recalled items, individuals with a sesame allergy or severe sensitivity are at risk of experiencing a serious or potentially life-threatening allergic reaction if they consume the product. All the affected products were wrapped in plastic. What People Are Saying The FDA, in an email to Newsweek in January: "Most recalls in the U.S. are carried out voluntarily by the product manufacturer and when a company issues a public warning, typically via news release, to inform the public of a voluntary product recall, the FDA shares that release on our website as a public service. "The FDA's role during a voluntary, firm-initiated, recall is to review the recall strategy, evaluate the health hazard presented by the product, monitor the recall, and as appropriate alert the public and other companies in the supply chain about the recall." It added: "The FDA provides public access to information on recalls by posting a listing of recalls according to their classification in the FDA Enforcement Report, including the specific action taken by the recalling company. The FDA Enforcement Report is designed to provide a public listing of products in the marketplace that are being recalled." What Happens Next Consumers who have a sesame allergy or sensitivity are advised to dispose of the affected product immediately and contact Sheehan Brothers Vending to receive a replacement pack. Anyone experiencing signs or symptoms of a foodborne illness or allergic reaction should seek medical attention promptly.
