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Outlook Therapeutics Provides Business Update and Reports Financial Results for the First Quarter of Fiscal Year 2020
First clinical trial results from the Phase 3 development program for ONS-5010 expected in six months CRANBURY, N.J., Feb. 14, 2020 (GLOBE NEWSWIRE) --
About this update from Outlook Therapeutics, Inc.
[{"type":"text","content":"First clinical trial results from the Phase 3 development program for ONS-5010 expected in six months\nCRANBURY, N.J., Feb. 14, 2020 (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 first quarter ended December 31, 2019.\n “This will be an exciting year for our company as we continue to advance towards our goal of a new BLA submission to the FDA for ONS-5010 in 2021 and, if approved, a commercial launch in 2022. Once achieved, these milestones will allow us to move forward with our priority to provide patients with the safety and efficacy of the first and only FDA-approved, responsibly priced ophthalmic formulation of bevacizumab,” said Lawrence A. Kenyon, President, Chief Executive Officer and Chief Financial Officer. “We are pleased to report that our Phase 3 development program for ONS-5010 continues to make progress, including ongoing patient recruitment for the NORSE 2 study, which is expected to be completed by the end of May 2020. In addition, we plan to announce the topline data for the NORSE 1 study in August 2020.” Recent ONS-5010 Highlights The Phase 3 clinical development program for ONS-5010 consists of two ongoing clinical trials, NORSE 1 and NORSE 2, to evaluate ONS-5010 against ranibizumab (LUCENTIS®) for wet age-related macular degeneration (wet AMD). The Company expects to announce a readout of the topline results from NORSE 1 in August 2020. The NORSE 1 study, which completed enrollment in August 2019, includes a total of 61 patients at nine sites in Australia. The endpoint for the study is the difference in mean change from baseline visual acuity at 11 months for ONS-5010 dosed on a monthly basis compared to LUCENTIS dosed using the PIER alternative dosing regimen of three monthly doses followed by quarterly dosing. NORSE 1 will provide initial safety and efficacy data for ONS-5010 in wet AMD patients. The Company is currently enrolling patients in the NORSE 2 trial, and is expected to enroll a total of approximately 220 patients at more than 40 clinical trial sites in the United States. Patients in the trial will be treated for 11 months. In agreemen...