Outlook Therapeutics (OTLK) Stock Gains On Phase 3 Data

Outlook Therapeutics Inc (NASDAQ: OTLK) is screaming for the top in the market this morning, and for good reason. The company announced positive clinical data from an age-related macular degeneration study. Here’s what’s happening:

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OTLK Announces Positive Data

In the press release, Outlook Therapeutics said that it produced highly statistically significant top-line results from its Phase 3 NORSE TWO safety and efficacy trial of LYTENAVA for the treatment of neovascular age-related macular degeneration, also known as wet AMD. 

OTLK went on to explain that top-line data showed that ONS-5010 bevacizumab-vikg met the primary and key secondary endpoints for efficacy with clinically impactful changes observed for treated patients. 

The primary endpoint was the difference in proportion of subjects gaining at least 15 letters BCVA was met and was highly statistically significant and clinically relevant, which was met. Moreover, safety data showed what was to be expected based on data from previous trials. 

Management Commentary

In a statement, C. Russell Trenary III, President and CEO at OTLK, had the following to offer:

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. I would like to thank the trial participants and investigators, our partners, and our employees for their contributions to NORSE TWO.

The statement above was followed up by Terry Dagnon, COO of OTLK, with:

In meeting both the primary and key secondary endpoints in NORSE TWO with highly significant clinically relevant results, we have achieved the requirements agreed upon with the FDA, and when combined with our previously reported clinical trial results, this completes the clinical package necessary for the submission of our BLA. We look forward to working with the FDA and other global authorities to potentially bring this new option to providers, clinicians, and patients as quickly as possible as an alternative to off-label IV repackaged bevacizumab, that is not approved for ophthalmic use.

Finally, Firas Rahhal, MD, Senior Partner at REtina-Vitreous Associates Medical Group and Associate Clinical Professor of Ophthalmology at the UCLA School of Medicine, had the following to add:

As an Investigator in the NORSE TWO trial, I find these clinically relevant results, most notably the 41% of ONS-5010 patients who gained three lines of vision, to be very exciting for the retina community and confirm what we all had hoped to see in the investigation of ONS-5010 to treat wet AMD. Clearly, in this trial ONS-5010 appears to be a potential option as an ophthalmic bevacizumab. As a clinician, I look forward to supporting the submission for FDA approval and including ONS-5010 as an important treatment option for wet AMD patients, if approved.

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Final Thoughts

All told, the news released by Outlook this morning proved to be overwhelmingly positive. With the Phase 3 study meeting its primary and secondary endpoints while generating a positive safety profile, an FDA submission is likely on the horizon, making OTLK one to watch closely. 

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