Outlook rises on positive Phase III Lytenava results

Shares of New Jersey, USA-based Outlook Therapeutics (Nasdaq: OTLK) leapt nearly 27% to $2.87 pre-market yesterday, after it announced positive clinical and highly statistically-significant top-line results from its pivotal Phase III NORSE TWO safety and efficacy trial evaluating ONS-5010/Lytenava (bevacizumab) for treatment of neovascular age-related macular degeneration (wet AMD).

Outlook is working to develop and launch the first Food and Drug Administration-approved ophthalmic formulation of bevacizumab, Roche (ROG: SIX) and Genentech’s Avastin (bevacizumab) that is used off-label, for use in retinal indications.

“We are delighted with the compelling results observed in NORSE TWO, which represent a significant and potentially transformational milepost for patients suffering from wet AMD. We plan on bringing the first ophthalmic formulation of bevacizumab to market, if approved. Currently there are a vast number of off-label injections of bevacizumab to treat retinal disease in the United States, and we want to offer an alternative for patients and retinal surgeons that is approved and formulated and packaged specifically for wet AMD. The successful completion of this trial is the final step needed in our clinical evaluation of ONS-5010 to enable us to submit a Biologics License Application to the FDA in the first calendar quarter of next year,” said C Russell Trenary III, president and chief executive of Outlook Therapeutics.