Business
Outlook Therapeutics Provides Business Update and Reports Financial Results for Fiscal Year 2019
Topline results from the NORSE 1 study of ONS-5010 expected to be announced in the third quarter of calendar 2020Enrollment in the NORSE 2 study underwaySPA
About this update from Outlook Therapeutics, Inc.
[{"type":"text","content":"Topline results from the NORSE 1 study of ONS-5010 expected to be announced in the third quarter of calendar 2020Enrollment in the NORSE 2 study underwaySPA agreement reached with FDA for NORSE 4, 5 and 6 studies CRANBURY, N.J., Dec. 19, 2019 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ: OTLK) (the “Company”), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced business highlights and financial results for its fiscal year ended September 30, 2019.\n Recent Highlights: Completed patient enrollment in the NORSE 1 study for ONS-5010, an investigational ophthalmic formulation of bevacizumab, in wet age-related macular degeneration (wet AMD); topline results expected to be announced in the third quarter of calendar 2020Initiated dosing of patients in the NORSE 2 study for ONS-5010 in wet AMD; topline results expected to be announced in the first quarter of calendar 2021Announced agreement with U.S. Food and Drug Administration (“FDA”) on Special Protocol Assessments (“SPAs”) for clinical trial protocols for NORSE 4 for branch retinal vein occlusion (“BRVO”) and NORSE 5 and NORSE 6 for diabetic macular edema (“DME”) “We continue to execute against our Phase 3 clinical program for ONS-5010, and remain on track with our goal of a commercial launch in 2022, pending the successful outcome of our trials and approval by FDA,” said Lawrence A. Kenyon, President, Chief Executive Officer and Chief Financial Officer. “We saw great progress in 2019. As we continue to make progress, 2020 will also be an important year for Outlook Therapeutics and the ONS-5010 program as we continue our efforts to provide patients and their physicians with an FDA-approved, responsibly priced, ophthalmic formulation of bevacizumab.” Recent ONS-5010 Highlights In the fourth quarter of fiscal 2019, the Company announced that the NORSE 1 study completed enrollment with a total of 61 patients at nine sites in Australia. The study is the first of two ongoing adequate and well-controlled registration clinical trials evaluating ONS-5010 against ranibizumab (LUCENTIS®) for wet AMD. The endpoint for the study is a mean change in baseline visual acuity at 11 months for ONS-5010 dosed on a monthly basis compared to ranibizumab dosed using the P...