Outlook Therapeutics Reaches Agreement With FDA on Special Protocol Assessments for ONS-5010

Outlook Therapeutics, formerly known as Oncobiologics, said this month that it has reached an agreement with the FDA on 3 special protocol assessments for clinical trials of ONS-5010, a formulation of bevacizumab intended to treat retinal diseases.

In a statement, the company indicated that the agreements reached cover protocols for 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.

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).

“We hope that ONS-5010 will become the first FDA-approved bevacizumab indicated for these diseases. An on-label bevacizumab would enable clinicians to treat their retinal patients with a well-established therapy, and FDA approval would ensure sterility, potency and accurate, safe syringes for intravitreal injections,” said Lawrence A. Kenyon, president, chief executive officer, and chief financial officer, in a statement announcing the agreements.

Last year, the company revealed that it is developing the product as an innovator therapy, and it will not use the biosimilar pathway for eventual approval in order to gain an indication for ophthalmologic use; while the innovator bevacizumab (Avastin) is frequently used to treat eye diseases, and while it has been demonstrated to be markedly more cost-effective than other anti—vascular endothelial growth factor therapies (such as aflibercept and ranibizumab) in this setting, neither the innovator drug nor its approved biosimilars have approved indications for intravitreal injections.

The lack of regulatory approval to treat AMD and other eye disorders with bevacizumab has not stopped some health systems—such as the United Kingdom’s National Health Service (NHS)—from making extensive use of bevacizumab for eye diseases. In 2018, a UK court issued a ruling allowing the NHS to treat patients with AMD using bevacizumab without an approval from the European Medicines Agency in the indication.