Outlook Therapeutics (OTLK) is a clinical stage bio-pharmaceutical working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications. Outlook Therapeutics’ main purpose is to treat retinal diseases using ONS-5010.
ONS-5010 is an investigatory ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet AMD and other retinal diseases. ONS-5010 is currently being evaluated in two adequate and well-controlled registration clinical trials for wet AMD (NORSE 1 and 2) and, if successful, is expected to be submitted to the FDA as a new BLA for this ophthalmic indication.
If approved, ONS-5010 would be the first and only FDA-approved ophthalmic formulation of bevacizumab to treat retinal diseases. The Company currently intends to commercialize ONS-5010 in both vials and single-use pre-filled syringes.
Just recently, Outlook Therapeutics has received FDA approval for three protocols. NORSE 4, a registration clinical trial in patients with branch retinal vein occlusion, and NORSE 5 and NORSE 6, which will enroll patients with diabetic macular edema. All 3 trials are expected to begin in 2020, this year.
These studies will begin after enrollment has been completed in the ongoing trial NORSE 2, which is studying the drug in age-related macular edema (AMD).
The three trials will be conducted as Special Protocol Assessments (SPA), SPA is a process in which sponsors may request that FDA fully review their study protocols in order to reach agreement on the design and size of certain clinical trials, clinical studies or animal studies to determine if they adequately address scientific and regulatory requirements for a study that could support marketing approval. An SPA agreement indicates concurrence by FDA with the adequacy and acceptability of specific critical elements of overall protocol design (e.g., entry criteria, dose selection, endpoints and planned analyses) for a study intended to support a future marketing application. These elements are critical to ensuring that the trial conducted under the protocol can be considered an adequate and well-controlled study that can support marketing approval. However, an SPA agreement does not indicate FDA concurrence on every protocol detail, does not guarantee approval and may be rescinded.
Outlook Therapeutics (OTLK) Analysis
It appears that more than several institutional investors and hedge funds decided to increase stakes in OTLK in the recent period. That is how LVW Advisors LLC now has an increase position in OTLK by 37.59% in the first quarter, owning 389088 shares of OTLK stocks, with the value of $404652 after the purchase of an additional 106,293 shares during the last quarter. In the meanwhile, Geode Capital Management LLC also increased their stake in OTLK shares changed 107.01% in the first quarter, which means that the company now owns 67237 shares of company, all valued at $69926 after the acquisition of additional 34,757 shares during the last quarter.
Outlook Therapeutics (OTLK) Final Thoughts
Outlook Therapeutics should definitely be on your buyers list, as eye disease and impairment are very common, according to a study, retinal diseases affect more than 5 million people with age related macular degeneration and cataracts as the highest cause of legal blindness and visual impairment.
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