Outlook Therapeutics Provides Update on First Approved Ophthalmic Formulation of Bevacizumab-vikg for Advanced Macular Degeneration
Outlook Therapeutics announced progress on its phase 3 clinical program for the first FDA-approved ophthalmic formulation of bevacizumab-vikg (Lytenava) for use in retinal indications (known as ONS-5010 for use in retinal indications).
Outlook plans the commercial launch of ONS-5010 in 2022, and recently completed a strategic partnership for commercialization in Greater China and is in discussions with other strategic partners for commercial launches in the United States, Asia and Europe.
Clinical Progress Drives ONS-5010 Towards U.S. and EU Filings in 2021
Outlook Therapeutics has already demonstrated both safety and efficacy through a recently reported clinical experience trial and, separately, has also completed enrollment of 227 patients in its U.S.-based phase 3 pivotal trial. The clinical experience trial gives Outlook Therapeutics a high level of confidence in the outcome of the ongoing fully-enrolled pivotal trial, according to a company news release. Pivotal data are expected mid-2021 followed by submission of a U.S. Biologics License Application (BLA) to the FDA. If the BLA is approved, it will result in 12 years of marketing exclusivity. Outlook Therapeutics is on track for both U.S. BLA filing and EU Marketing Authorization Application (MAA) filings in 2021.
ONS-5010 Addresses Significant Unmet Medical Need
Although unapproved repackaged IV Avastin from compounding pharmacists is widely used by retinal specialists, extensive marketing research has indicated that there is a significant unmet medical need for an approved ophthalmic formulation of bevacizumab that removes both the product liability and safety concerns of a repackaged product. Once approved, Outlook Therapeutics’ ONS-5010 will reduce the need for use of unapproved repackaged IV Avastin from compounding pharmacists. Upon approval, ONS-5010 will be the first ophthalmic formulation of bevacizumab-vikg approved as an anti-VEGF therapy addressing vision loss from wet age-related macular degeneration (AMD). Outlook Therapeutics also intends to seek approval of ONS-5010 for other approved indications, including branch retinal vein occlusion (BRVO) and diabetic macular degeneration (DME).
Commercial Planning Activities Underway
Commercial launch planning has begun, including distribution, physician and patient outreach, key opinion leader support and payor community engagement. With an enhanced safety and cost-effective profile, Outlook Therapeutics expects ONS-5010 to be widely adopted by payors and clinicians worldwide and to become the first-line drug of choice for payor-mandated “step edit” in the United States for retinal indications.
Extensive market research indicates that ONS-5010, if approved, will be a significant therapy in the retinal anti-VEGF market, currently estimated to be in excess of $13 billion worldwide.