- Outlook Therapeutics advancing first ever ophthalmic formulation of bevacizumab towards new U.S. FDA Biologics License Application (BLA) submission, anticipated this quarter
- ONS-5010 / LYTENAVA™ (bevacizumab-vikg) expected to receive, if approved, 12 years of regulatory exclusivity in the U.S. estimated $13 billion global ophthalmic anti-VEGF market
- Strong balance sheet to support the Company’s expected capital needs through the anticipated approval of the ONS-5010 BLA expected in the first calendar quarter of 2023
ISELIN, N.J., Jan. 25, 2022 (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 provided a business outlook for 2022.
“The past twelve months have been truly transformational for Outlook Therapeutics. Building off of that momentum, we continue to progress toward our targeted BLA submission this quarter and ultimately potential FDA approval. Now more than ever, we believe that ONS-5010 has the opportunity to address a significant unmet need among the retina community and the potential to provide physicians with a safe, effective, and FDA-approved version of bevacizumab that meets standards required for ophthalmic injections. With the potential for impactful milestones on the horizon, we believe we are positioning ourselves for success and remain dedicated to advancing this program to unlock the full potential of Outlook Therapeutics,” commented Mr. C. Russell Trenary III, President and Chief Executive Officer of Outlook Therapeutics. “We look forward to an exciting year for Outlook Therapeutics and our continued efforts to bring ONS-5010 for wet AMD over the finish line.”
ONS-5010 / LYTENAVA™
ONS-5010 / LYTENAVA™ (bevacizumab-vikg) is an investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet age-related macular degeneration (wet AMD) and other approved retinal diseases. Since no approved ophthalmic formulations of bevacizumab are available, clinicians wishing to treat retinal patients with bevacizumab have had to use unapproved repackaged IV bevacizumab provided by compounding pharmacists, products that have risk of contamination and inconsistent potency and availability. If approved, ONS-5010 will replace the need to use unapproved repackaged IV bevacizumab from compounding pharmacists for the treatment of wet AMD.
With the registration clinical trials now completed, Outlook Therapeutics plans to submit a new BLA under the Public Health Service Act (PHSA) 351(a) regulatory pathway in the first quarter of calendar 2022. If the BLA is approved as anticipated in the first quarter of calendar 2023, 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.
As previously announced, if ONS-5010 receives FDA approval, Outlook Therapeutics plans to file a supplementary application for approval to provide the product in a pre-filled, silicone oil free syringe that will meet the strict specifications for ophthalmic use. In anticipation of potential approval, Outlook Therapeutics is conducting NORSE SEVEN to compare the safety of ONS-5010 in vials versus pre-filled syringes. NORSE SEVEN will enroll approximately 120 subjects with visual impairment due to retinal disorders. Patients will be treated for three months and the enrollment of patients in the arm of the study receiving ONS-5010 in vials has been completed.
Upcoming Milestones
- Planned submission of new BLA to the FDA in the first calendar quarter of 2022;
- Execution of the NORSE SEVEN study evaluating Outlook Therapeutic’s vial delivery system versus a pre-filled syringe of ONS-5010;
- Ongoing pre-launch commercial planning underway in anticipation of potential ONS-5010 approval; and
- Continued progress on preparation for NORSE FOUR (BRVO) and NORSE FIVE AND SIX (DME) evaluating ONS-5010 for additional ophthalmic indications.
“As we advance toward a potential commercial launch of ONS-5010, we are working diligently to build the proper infrastructure to support a launch in the U.S. This includes onboarding our commercial team, expanding our operations team, and collaborating with the retina community to provide education and build awareness. Additionally, we are conducting our NORSE SEVEN study to evaluate our vial delivery systems versus a pre-filled syringe of ONS-5010. While not a gating item in our planned BLA submission or potential approval, we believe that a pre-filled syringe will be a key differentiator in the marketplace, providing a more user-friendly delivery system designed for ophthalmic use,” added Mr. Trenary.
Pre-Commercialization Planning Underway
Per the National Eye Institute (NEI), use of unapproved repackaged IV bevacizumab from compounding pharmacies is estimated to account for at least 50% of all wet AMD prescriptions in the United States each year. Globally, the nine major markets account for an estimated $13.1 billion market for anti-VEGF drugs to treat retina diseases.
In anticipation of potential FDA marketing approval in 2022 for ONS-5010, Outlook Therapeutics has begun commercial launch planning, including manufacturing with drug substance manufacturer FUJIFILM Diosynth Biotechnologies and best-in-class drug product manufacturer Aji Biopharma Services, 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 – patients, clinicians and payors – Outlook Therapeutics has already commenced collaborative discussions with payors and the retina community. Outlook Therapeutics is also developing registration documents on a parallel path for approvals in Europe and expects to submit them shortly after completing the BLA submission. Outlook Therapeutics continues to explore potential strategic commercialization partners, such as Syntone Biopharma JV in China. Outlook Therapeutics expects ONS-5010, if approved, to be a safe and cost-effective choice for patients, clinicians and payors worldwide for retinal indications.
In addition to the clinical development program evaluating ONS-5010 for wet AMD, Outlook Therapeutics has received agreements from the FDA on three Special Protocol Assessments (SPAs) for three additional registration clinical trials. These SPAs cover the protocols for a planned registration clinical trial evaluating ONS-5010 to treat branch retinal vein occlusion (BRVO, NORSE FOUR) and two planned registration clinical trials evaluating the drug candidate for the treatment of diabetic macular edema (DME, NORSE FIVE and NORSE SIX). Outlook Therapeutics currently expects to initiate registration clinical trials for ONS-5010 for DME and BRVO in 2023 if FDA approval is received for the wet AMD indication.
