Unapproved Repackaged IV Bevacizumab from Compounding Pharmacies

For many years, anti-VEGF therapy has been the standard of care for many ophthalmic diseases, including wet AMD, DME and BRVO. However, although multiple branded drugs have been approved for these indications (e.g., LUCENTIS®, EYLEA® and BEOVU®), they are very expensive. There is no FDA-approved ophthalmic formulation of bevacizumab, and doctors who wish to treat their retinal patients with a less expensive anti-VEGF drug often use unapproved repackaged intravenous (IV) bevacizumab (Avastin®) provided by compounding pharmacies.

The unapproved repackaged IV bevacizumab for ophthalmic use that is provided by compounding pharmacies has a well-documented history of risks from contamination (including silicone oil droplet contamination from syringes) and inconsistent potency and availability, with potentially severe consequences, as leading retinal societies have reported. For these reasons, the retina community and payors have shown interest in the development of an ophthalmic formulation of bevacizumab that would be an FDA-approved alternative to unapproved repackaged IV bevacizumab from compounding pharmacies.

To meet this retinal market need, Outlook Therapeutics is developing and expects to launch ONS-5010 as an ophthalmic formulation of bevacizumab. If approved, it will provide a viable treatment option, approved by the FDA and other countries’ regulatory agencies, across the spectrum of anti-VEGF ophthalmic drugs that are used to treat wet AMD, DME and BRVO. Additionally, if approved, it would avoid the potential safety, sterility, potency, availability and syringe drawbacks that can occur with unapproved repackaged IV bevacizumab from compounding pharmacies.

Outlook Therapeutics has executed a supply agreement for a best-in-class pre-filled ophthalmic syringe that is expected to provide both ease-of-use for clinicians and add to ONS-5010’s potential safety profile over the current unapproved therapies that have caused problems related to syringe malfunction, contamination, etc.

About Bevacizumab

Bevacizumab-vikg is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection the binding of bevacizumab-vikg to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina.

Since the advent of anti-VEGF therapy, it has become the standard-of-care treatment option within the retina community globally (National Eye Institute).