Outlook Therapeutics’ second attempt to obtain US approval for its wet age-related macular degeneration (wet AMD) therapy, Lytenava (bevacizumab-vikg) has suffered a setback as the therapy failed to meet a key endpoint in Phase III NORSE EIGHT trial.
Although the NORSE EIGHT study (NCT06190093) did not meet the pre-specified non-inferiority endpoint at eight weeks outlined in the special protocol assessment (SPA) with the US Food and Drug Administration (FDA), Outlook was quick to note that it is moving forward with its plans to gain US approval for Lytenava, adding that it intends to resubmit the biologics license application (BLA) with complete analysis of the NORSE EIGHT trial in Q1 2025.
In August 2023, the FDA declined to approve Lytenava as a treatment for wet AMD. The US regulatory agency cited several manufacturing issues and the need for additional confirmatory clinical data which Outlook intends to supply from the NORSE EIGHT trial.
After Outlook released preliminary topline results of the NORSE EIGHT study, the company’s stock tanked and was down by over 79% in premarket trading today (27 November).
The preliminary results from the NORSE EIGHT trial showed that the mean change in best corrected visual acuity (BCVA) from baseline to eight weeks was +4.2 letters with Lytenava, compared to +6.3 letters improvement seen with Roche’s Lucentis (ranibizumab), an FDA approved wet AMD therapy. The therapies had a comparable safety profile, with similar overall ocular adverse event rates in both therapy groups.
Outlook noted that it is still collecting the three-month data from the trial and continuing analysis. The company expects full three-month safety and efficacy results to be available in January 2025. The company added that it has completed the remediation of the Chemistry, Manufacturing and Controls (CMC) comments in the Complete Response Letter (CRL) issued by the FDA last year.
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The company also noted that it potentially intends to launch Lytenava in the UK and Germany in 2025, as the therapy is approved by the European Commission and Medicines and Healthcare products Regulatory Agency (MHRA) Marketing Authorisation for the treatment of wet AMD. Adding that Outlook is exploring potential partnerships for global markets, excluding the US.
