Outlook Reports Final Results of Lytenava Trial, Plans BLA Resubmission in Q1-2025

Outlook Therapeutics reported Jan. 16 the final results of the NORSE EIGHT trial of ONS-5010 (Lytenava), an ophthalmic formulation of bevacizumab for wet age-related macular degeneration (AMD).

ONS-5010 demonstrated non-inferiority to ranibizumab at week 12, Outlook said. The Iselin, New Jersey, company said it would resubmit the biologics license application (BLA) for ONS-5010 in Q1-2025.

Outlook had reported topline results in November in which Lytenava did not meet its non-inferiority endpoint at week eight. At that timepoint, the Lytenava treatment arm demonstrated a mean +4.2 letter improvement in best-corrected visual acuity, while the ranibizumab arm saw a +6.3 letter improvement.

At week 12, however, the mean change narrowed to +5.5 letters for Lytenava and +6.5 letters for ranibizumab.

With Lytenava, Outlook aims to replace the off-label practice of using intravenous bevacizumab (the cancer drug Avastin) repackaged for intravitreal injection.

The US FDA rejected Lytenava in August 2023, citing several chemistry, manufacturing, and controls issues and observations from pre-approval manufacturing inspections, plus a need for further confirmatory clinical evidence.

The NORSE EIGHT trial was launched in January 2024 to address those concerns. Approximately 400 treatment-naïve wet AMD subjects were randomized 1:1 to receive 1.25 mg ONS-5010 or 0.5 mg ranibizumab IVT injections.

Lytenava was approved for wet AMD in the EU in May 2024 and in the UK in July 2024. The company, with its commercial partner, Cencora, said it is readying a launch in Europe in H1-2025.

Outlook also announced a fundraising where the exercise of existing warrants was expected to result in gross proceeds up to $20.4 million. The company said it would use the net proceeds to fund the ONS-5010 clinical program and European commercial launch of Lytenava; and for working capital and general corporate purposes.