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Outlook Therapeutics , Inc. Logo Outlook Therapeutics Reports Financial Results for Third Quarter of Fiscal Year 2021 and Provides Corporate Update August 13 , 2021 • Reported positive , statistically significant top - line efficacy and safety data from pivotal Phase 3 NORSE TWO trial of ONS - 5010 / LYTENAVA ™ ( bevacizumab - vikg ) for the treatment of wet age - related macular degeneration ( wet AMD ) • On track to submit new U.S. BLA for ONS - 5010 in the first quarter of calendar 2022 and pre - commercial launch planning underway ISELIN , N.J. , Aug. 13 , 2021 ( GLOBE NEWSWIRE ) -- Outlook Therapeutics , Inc. ( Nasdaq : OTLK ) , a biopharmaceutical company working to develop and launch the first FDA - approved ophthalmic formulation of bevacizumab for use in retinal indications , today announced recent corporate highlights and financial results for its fiscal third quarter ended June 30 , 2021 . Outlook Therapeutics also provided a clinical development and pre - commercialization update on ONS - 5010 / LYTENAVA ™ ( bevacizumab - vikg ) , its investigational ophthalmic formulation of bevacizumab for the treatment of wet age - related macular degeneration ( wet AMD ) and other retinal indications . Recent Corporate Highlights • Announced positive top - line results from pivotal Phase 3 NORSE TWO safety and efficacy trial evaluating ONS - 5010 for treatment of wet AMD ; and • Appointed C. Russell Trenary III as President , Chief Executive Officer and a member of the Board of Directors . Mr. Trenary brings over 35 years of experience in the life sciences industry , specifically in medical ophthalmic implant sales , marketing , and business development . Over the course of his career , he has led four major product launches in eye care medical devices . Additionally , Mr. Trenary has played a key role in seven acquisitions including , most recently , the sale of InnFocus , Inc. to Santen . " The past quarter for Outlook Therapeutics has been truly transformative for the company . With all three of our registration clinical trials now completed , including our NORSE TWO pivotal trial , we possess positive , statistically significant results to support our plans to submit a BLA for ONS - 5010 in the first calendar quarter of 2022. I believe there is a tremendous amount of opportunity ahead for Outlook Therapeutics and , since I joined as CEO at the beginning of July , the dedication of this team , and the potential of ONS - 5010 , have continued to reinforce my confidence in our position as an up - and - coming leader in the retina space . We are dedicated to building momentum , shareholder value , and ultimately potentially bringing the first FDA - approved ophthalmic formulation of bevacizumab to the retina community , " commented Mr. C. Russell Trenary III , President and Chief Executive Officer of Outlook Therapeutics . ONS - 5010 ( bevacizumab ) Clinical Program Overview Outlook Therapeutics ' wet AMD ONS - 5010 clinical program for the planned BLA submission consists of three clinical trials , NORSE ONE , NORSE TWO , and NORSE THREE , all of which have now been completed . Most recently , Outlook Therapeutics reported positive topline data from its NORSE TWO pivotal Phase 3 clinical trial . The topline data from NORSE TWO demonstrated that ONS - 5010 is safe and met the primary and key secondary endpoints for efficacy . In NORSE TWO , ONS - 5010 achieved statistically significant and clinically relevant primary ( p = 0.0052 ) and key secondary ( p = 0.0043 ) efficacy endpoints with 41 % of subjects gaining at least 15 letters of BVCA . ONS - 5010 was also found to be safe and well tolerated in the NORSE TWO trial . With the registration clinical trials now completed , Outlook Therapeutics plans to submit a BLA under the Public Health Service Act ( PHSA ) 351 ( a ) regulatory pathway in the first quarter of calendar 2022. If the BLA is approved , it is expected to result in 12 years of marketing exclusivity for ONS - 5010 as the first and only ophthalmic formulation of bevacizumab approved by the FDA to treat wet AMD . " We couldn't be more pleased with the results from our pivotal study , and now with this added confidence in the potential of ONS - 5010 backed by data , we are continuing our shift towards commercialization . The retinal anti - VEGF market represents a significant opportunity , currently estimated to be in excess of $ 13.1 billion worldwide , and growing annually . We are stepping into a space in need of an FDA - approved ophthalmic formulation of bevacizumab , the most frequently used treatment for wet AMD in the United States . If approved , we believe ONS - 5010 would bring added assurance to physicians , patients , and payors in the retina community with a treatment for wet AMD that meets the FDA's standards and potentially eliminates issues seen with unapproved repackaged IV bevacizumab . Additionally , we believe there is opportunity beyond wet AMD and we look forward to continuing to evaluate and work towards those market expansion opportunities , ” added Mr. Trenary . Pre - commercialization Planning Underway In anticipation of potential FDA marketing approval in 2022 for ONS - 5010 , Outlook Therapeutics has begun commercial launch planning activities , including manufacturing with drug substance manufacturer FUJIFILM Diosynth Biotechnologies and best - in - class drug product manufacturer Aji Biopharma Services , along with distribution , sales force planning , physician and payor advisory board outreach , key opinion leader support and payor community engagement . To bring ONS - 5010 to market in a way that benefits all stakeholders - clinicians , patients and payors - Outlook Therapeutics has already commenced collaborative discussions with payors and the retina community . Outlook Therapeutics expects ONS - 5010 , if approved , to be a safe and cost - effective choice for patients , payors and clinicians worldwide for retinal indications . Outlook Therapeutics is also developing registration documents on a parallel path for approvals in Europe and expects to submit them shortly after