Outlook Therapeutics, Inc. (OTLK)

[H2R]

Pre-launch activities, PDUFA August 29, 2023, just three short months away.

These initiatives are focused on positioning Outlook Therapeutics as an upcoming leader in the anti-VEGF space by meeting FDA requirements for an ophthalmic approval. The ONS-5010 Biologics License Application (BLA) was submitted and accepted for filing by the FDA as a 351(a) stand-alone BLA. We believe ONS-5010, if approved, has the potential to be the standard of care in the retinal anti-VEGF space and look forward to potentially bringing to market the first FDA-approved ophthalmic formulation of bevacizumab,” commented Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics.

Upcoming Anticipated Milestones

Continued progress with ongoing pre-launch commercial preparations in anticipation of potential approval for ONS-5010 in 2023;

PDUFA goal date of August 29, 2023;

Continued evaluation of ONS-5010 in a pre-filled syringe in the NORSE SEVEN clinical trial; and

Estimated decision date from the EMA’s CHMP on the Company’s submitted MAA in the EU for ONS-5010 expected in early 2024.

Commercial Planning Underway to Support Potential Approval of the First Ophthalmic Formulation of Bevacizumab for Use in Retinal Indications

According to GlobalData, the use of unapproved repackaged IV bevacizumab from compounding pharmacies is estimated to account for approximately 50% of all wet AMD injections in the United States each year. This represents approximately 3.5 million injections of off-label, repackaged bevacizumab each year in the United States alone. Globally, the nine major markets account for an estimated $13.1 billion market for anti-VEGF drugs to treat retina diseases.

Because patients, physicians and payors rely heavily on bevacizumab as an important option for treating wet AMD, ONS-5010 has been developed to address the potential potency and safety issues that have been reported to be associated with using off-label, repackaged bevacizumab from compounding pharmacies, including:

As reported in a study published in JAMA, 81% of all tested syringes of repackaged bevacizumab received from compounding pharmacies contained suboptimal protein concentrations, which could result in lower clinical efficacy.
Non-standard materials used to transfer and hold repackaged bevacizumab can potentially add particulates to non-ophthalmic-designed bevacizumab, which in turn may fail to meet the standards FDA requires for ophthalmic compounds.
In August 2022, Outlook Therapeutics submitted a PHSA 351(a) BLA for ONS-5010 as a standalone biologic to potentially become the only approved ophthalmic formulation of bevacizumab. ONS-5010, if approved, cannot qualify as a biosimilar because the PHSA requires a biosimilar to have the same “conditions of use” (e.g., indications) as a reference product. AVASTIN, the currently marketed non-ophthalmic formulation of bevacizumab, is not approved by FDA for the treatment of wet AMD or other retinal diseases.

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