Outlook Therapeutics trims workforce by 23% to fund Lytenava launch

Outlook Therapeutics, a biopharmaceutical company specialising in retina disease treatments, has announced a 23% workforce reduction as part of strategic cost-saving measures. This move is aimed at supporting the Lytenava commercial launch in the European Union and the United Kingdom while ensuring sufficient resources for a US Food and Drug Administration (FDA) biologics resubmission.

Financial Pressures Drive Workforce Reduction Strategy

The restructuring will generate $1.4 million in annual savings. Outlook Therapeutics, which reported $32 million in cash reserves as of June 30—down from $47.2 million at the end of March—views these cost-saving measures as essential for extending its financial runway. The workforce reduction strategy reflects the company’s focus on delivering the wet AMD treatment to patients in Europe and the UK.

Interim Chief Executive Officer Lawrence Kenyon stated that these actions, while difficult, are necessary to optimise resources for the Lytenava commercial launch. He emphasised the company’s confidence in Lytenava’s potential as a groundbreaking ophthalmic bevacizumab product for retina specialists and patients globally.

Lytenava’s Marketing Authorisation Approval

Lytenava is the first ophthalmic bevacizumab product to receive marketing authorisation approval in the EU and UK for wet AMD treatment. This condition, known as age-related macular degeneration, is caused by abnormal blood vessel growth in the retina, leading to vision loss. Lytenava works by blocking vascular endothelial growth factor (VEGF), reducing cell proliferation and vascular leakage in the eye.

Outlook Therapeutics plans to initiate the European commercial launch of Lytenava in the first half of 2025. The drug’s EU and UK approvals grant it 10 years of market exclusivity, further enhancing its appeal as a novel wet AMD treatment.

Regulatory Challenges in the United States

While the marketing authorisation approval in Europe and the UK marks a significant milestone, Lytenava (branded as ONS-5010 in the U.S.) is still investigational domestically. The company is conducting the NORSE EIGHT trial, an ongoing non-inferiority study aimed at securing FDA approval for the age-related macular degeneration treatment.

Preliminary trial data showed improvements in vision and a favourable safety profile, but the drug fell short of meeting its pre-specified endpoint during earlier phases. Full trial results are expected in January 2025, after which Outlook Therapeutics plans to submit a FDA biologics resubmission for Lytenava in Q1 2025. If approved, Lytenava would become the first ophthalmic bevacizumab approved for wet AMD treatment in the United States.

NICE Recommendation Bolsters Confidence

In a significant endorsement, the UK’s National Institute for Health and Care Excellence (NICE) has recommended Lytenava as a wet AMD treatment option, underscoring the drug’s clinical utility and market potential. This recognition further supports the company’s confidence in its ability to execute a successful European commercial launch.

Outlook’s Road Ahead

While the company faces financial pressures, its focus on streamlining biopharmaceutical company operations and advancing Lytenava’s commercial launch preparations could position it for growth. However, much depends on its ability to meet regulatory standards in the U.S. and deliver on its promise as a leader in wet AMD treatment innovation.