– USA, NJ – 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 the appointment of C. Russell Trenary III to its Board of Directors as President and CEO, succeeding Lawrence Kenyon, who has served as President, CEO and CFO since June 2018, and will continue serving as CFO and as a member of the Board of Directors.
“We are pleased to welcome Russ to the executive leadership team. We believe his leadership and expertise is an invaluable asset as we look to optimize our position in the retina industry and prepare to submit a Biologics License Application for ONS-5010 and, if approved, launch our commercialization efforts. With the addition of Russ, we have the right leadership team to develop a fully integrated ophthalmic company,” said Executive Chairman, Randy Thurman.
He added on behalf of the Board, “We are very fortunate to be able to bring Russ on to the Outlook Therapeutics team at this important point in the ONS-5010 program. Russ’ history of providing experienced CEO leadership, multiple successful eye health related product launches and value creation for shareholders will be important as we turn our focus to building Outlook Therapeutics and launching the next phase for ONS-5010. We are excited about the continued evolution of Outlook Therapeutics and believe we are poised for continued progress in the near and long-term. Furthermore, the Board would like to thank Larry Kenyon who has served as Outlook’s President, CEO and CFO for the last 3 years. During that time, Larry successfully restructured the company, completed several rounds of fundraising and led Outlook Therapeutics to this successful moment of transition. We are very pleased that Larry will continue as Chief Financial Officer and a member of our Board.”
About Russell Trenary
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 closely 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.
“I am thrilled to be joining Outlook Therapeutics at such a critical point in the company’s history. If approved, ONS-5010 represents a rare opportunity to transform the standard of care and significantly impact the retina market for years to come,” said Mr. Trenary, President and CEO. “I would like to congratulate Larry and the rest of the executive leadership team for their efforts in bringing Outlook Therapeutics to this transition point. I look forward to building on this momentum and driving Outlook Therapeutics to the next transformational phase of growth.”
Mr. Trenary joins Outlook Therapeutics having most recently served as an Executive Advisor at InnFocus Inc., after serving as President & CEO for seven years, including the company’s acquisition in August 2016 by Santen Pharmaceutical Co., Ltd. InnFocus is an early-stage company, pending FDA approval of the PRESERFLO MicroShunt® glaucoma device, and other microsurgical solutions for glaucoma based on SIBS technology. Prior to that, he served as President and CEO of G&H Orthodontics, a global medical device company, and served in a number of senior leadership positions at Advanced Medical Optics (AMO), Inc., including as President of the cataract business unit. Prior to that, Mr. Trenary held C-suite positions at Sunrise Technologies International, Inc., served as Senior Vice President, Worldwide Sales & Marketing / Officer at VidaMed, Inc. and held several senior leadership roles at Allergan, Inc., including as Senior Vice President and General Manager of the Medical Optics business unit.
About Outlook Therapeutics, Inc.
Outlook Therapeutics is a biopharmaceutical company working to develop and launch ONS-5010 / LYTENAVA (bevacizumab-vikg) as the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD, DME and BRVO. If ONS-5010 ophthalmic bevacizumab is approved, Outlook Therapeutics expects to commercialize it as the first and only FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal diseases in the United States, United Kingdom, Europe, Japan and other markets. Outlook Therapeutics expects to file ONS-5010 ophthalmic bevacizumab with the U.S. FDA as a new BLA under the PHSA 351(a) regulatory pathway.
Outlook Therapeutics remains on track to report topline data from its pivotal NORSE TWO safety and efficacy study evaluating ONS-5010 (bevacizumab-vikg) for treatment of wet age-related macular degeneration (wet AMD) in the third calendar quarter of 2021. Following the data readout for NORSE TWO, Outlook Therapeutics plans to submit a new BLA filing under the PHSA 351(a) regulatory pathway in the first quarter of calendar 2022. If the BLA is approved, it will 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.
Outlook Therapeutics is also developing registration documents on a parallel path for approvals in Europe and expects to submit them shortly after completing the filing to the FDA. While Outlook Therapeutics continues to target potential strategic commercialization partners, particularly for European markets, it is preparing to launch ONS-5010 in the United States by itself, pending FDA approval.
For more information : https://outlooktherapeutics.com/
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