Outlook Therapeutics Inc (NASDAQ:OTLK) recently revealed that it completed the enrollment of patients that will participate in the NORSE 2 clinical trial for ONS-5010 / LYTENAVA.
LYTENAVA is an ophthalmic formulation that is being developed for retinal indications. Outlook started enrolling patients in the NORSE 2 clinical study in July 2019, which means that it has taken around a year to reach the target number of patients that they planned to enroll in the study. The initial plan was to enroll 220 patients in the study, but the company signed up seven additional patients bringing the total to 227 patients.
The clinical trial will be conducted at 39 sites across the U.S, and the patients enrolled in the trial will be treated for 12 months. However, Outlook will set the primary endpoint at 11 months for patients with a minimum of 15 letters at best-corrected visual acuity (BCVA). This will apply for patients treated with ONS-5010, which will be administered to patients as a monthly dose. LUCENTIS will be administered as a monthly dose.
“We are extremely grateful to the patients and medical staff who continue to take part in this study, even amidst the effects of the COVID-19 pandemic,” stated Outlook Therapeutics CEO Lawrence A. Kenyon.
The CEO also expressed gratitude to the people who worked hard to ensure that the journey so far has been smooth and to facilitate the milestone that is completing the patient enrollment. Outlook Therapeutics’s medical advisor, Dr. Mark Humayun, stated that anti-VEGF therapy is still the most common approach to treating most ophthalmic diseases. However, anti-VEGF therapies tend to be expensive, and that is why many physicians prefer off-label repackaged bevacizumab that is often provided by compounding pharmacists
Dr. Hymayun believes that LYTENAVA will provide a safe, effective, and cost-friendly alternative for patients suffering from retinal diseases if it receives FDA approval. Outlook is also excitedly optimistic about the potential approval of ONS-5010 because it is the only existing on-label ophthalmic formulation of bevacizumab that targets retinal diseases. The anti-VEGF market is worth $9.1 billion, which means that the treatment will provide significant commercial opportunities for Outlook.