Outlook Therapeutics is focused on securing a new BLA approval from the U.S. FDA and European regulatory authorities for its investigational ophthalmic formulation of bevacizumab, known as ONS-5010 / LYTENAVA™ (bevacizumab-vikg).
The Company features an agile management team with hands-on expertise in conducting ophthalmic clinical trials within FDA regulatory guidelines and a deep knowledge about retinal medicine and the needs of retinal clinicians and their patients.
Outlook Therapeutics intends to complete development of ONS-5010 for filing as a new BLA for approved indications in wet age-related macular degeneration (wet AMD), diabetic macular edema (DME) and branch retinal vein occlusion (BRVO). If approved, ONS-5010 will be the first and only FDA-approved on-label ophthalmic formulation of bevacizumab for treating approved retinal diseases.
If ONS-5010 is approved, the Company expects to commercialize it through best-in-class partnerships. The first of these is a manufacturing partnership with FUJIFILM Diosynth Biotechnologies. FUJIFILM is an industry leader in biologic manufacturing, employing the highest caliber cGMP facilities.
Outlook Therapeutics intends to create goodwill and acceptance among payors, retinal specialists and patients through responsible pricing of ONS-5010.