06.09.21

Outlook Therapeutics Completes Patient Dosing in Phase 3 NORSE TWO Trial for Wet AMD

Source: Outlook Therapeutics

Outlook Therapeutics reported that it has administered the final dose to the last patient enrolled in its pivotal NORSE TWO safety and efficacy study evaluating ONS-5010 (bevacizumab-vikg) for treatment of wet age-related macular degeneration (AMD). Topline data are expected to be reported for NORSE TWO in the third calendar quarter of 2021. 

The NORSE TWO pivotal phase 3 clinical trial enrolled a total of 228 wet AMD patients at 39 clinical trial sites in the United States. Patients in the trial are being treated for 12 months. The primary endpoint for the study is the difference in proportion of patients who gain at least 15 letters in the best corrected visual acuity (BCVA) at 11 months for ONS-5010 dosed on a monthly basis, compared to Lucentis, which is being dosed quarterly per the PIER regimen.   

“We are very pleased to have completed patient dosing and take another step forward in completing our wet AMD clinical program for ONS-5010. On behalf of the Outlook Therapeutics team, I would like to thank the clinicians and participants in the study, whose dedication has made it possible,” Lawrence A. Kenyon, President, CEO and CFO, Outlook Therapeutics, said in a company news release. “We remain on track to report topline data in the third quarter and continue to execute against our plan to advance this much-needed ophthalmic formulation of bevacizumab to market. Following the upcoming data readout, we look forward to our planned new BLA submission for wet AMD in the first quarter of calendar 2022.” 

ONS-5010 (Bevacizumab-vikg) Registration Clinical Trial Program 

The clinical program for the planned ONS-5010 wet AMD BLA consists of three clinical trials: NORSE ONE, a proof-of-concept clinical experience trial in wet AMD patients; NORSE TWO, the pivotal phase 3 wet AMD trial powered for statistical significance; and NORSE THREE, a supplemental safety study in patients with wet AMD and other retina diseases undertaken to ensure that a sufficient number of patients have been dosed with ONS-5010 to support the BLA filing. Results from NORSE ONE and NORSE THREE demonstrated positive proof-of-concept and a safety profile consistent with that of prior published research on bevacizumab for ophthalmic use.  

Following the data readout for NORSE TWO expected next quarter, 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.  

Pre-Commercialization Planning Underway 

In anticipation of potential FDA marketing approval in 2022 for ONS-5010, Outlook Therapeutics has begun commercial launch planning, including distribution, sales force planning, physician and patient 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 intends to work collaboratively with payors and the retina community. Outlook Therapeutics expects ONS-5010, if approved, to be a safe and cost-effective choice for payors and clinicians worldwide and to become a first-line drug of choice 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 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. 

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 expects to initiate registration clinical trials for ONS-5010 for DME and BRVO later in calendar 2021 or in early calendar 2022. 

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