Outlook Therapeutics Inc. (NASDAQ:OTLK) has been in the front line in developing FDA-approved ophthalmic formulations. Its primary product has been ONS-5010 / LYTENAVA™ (bevacizumab-vikg), a potential treatment for wet age-related macular degeneration (wet AMD). This is from a NORSE 1 clinical study, which is small, but its medical advisor Mark Humayun says it is already demonstrating efficacy signals.
The clinical safety data for NORSE 1 for ophthalmic bevacizumab was consistent with results published previously for ophthalmic bevacizumab. If approved by the FDA, ONS-5010, the eradication of wet AMD and other retinal diseases will have gained a great deal. This will also be a significant development in the practice of ophthalmology.
The results from NORSE 1 Validate the Company’s Confidence
ONS-5010 is to be administered as an intravitreal injection. There are bevacizumab products currently FDA-approve; hence this will become the first once it is approved. The company’s goal is to have it launched in Japan, Europe, the United States, and other markets. It is also hopeful of singling out the ophthalmic formulation to treat diabetic macular edema (DME).
The positive trends in efficacy in the NORSE 1, ONS-5010 was encouraging. It was shown to be safe and well-tolerated. Unlike in many no adverse events associated with inflammation, ONS-5010 did not show any indicators of adverse events associated with inflammation. The CEO and CFO of Outlook Therapeutics, Lawrence Kenyon, says that results from the NORSE 1 have validated the company in designing its ongoing NORSE 2 trial.
The NORSE 2 trial is expected to meet the Endpoint of the Study
The results from NORSE 1 has laid out a platform for the ongoing pivotal NORSE 2 clinical trial. However, it will not enroll patients with vision better than 20/50. It will also exclude those who have previously received treatment for wet AMD. Mr. Kenyon says that they are optimistic enrolling patients who can meet the endpoint of the study.
Even though the NORSE 2 study is somewhat similar to the NORSE 1 study, it is larger and is primarily for the treatment-naïve patient population.