Outlook Therapeutics (NASDAQ:OTLK) is advancing on multiple fronts, including: progress on its Phase 3 clinical program, manufacturing and regulatory activities, and global strategic partnering negotiations, all leading to the planned commercial launch of ONS-5010 anticipated in 2022.
Pivotal data from Phase 3 ONS-5010 trial are expected mid-2021 followed by a BLA submission. If 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 filings in 2021.
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 (wet AMD). OTLK also intends to seek approval of ONS-5010 for other approved indications, including branch retinal vein occlusion and diabetic macular degeneration.
Commercial launch planning for ONS-5010 has begun, including distribution, physician and patient outreach, key opinion leader support and payor community engagement.
Outlook Therapeutics is working with FujiFilm Diosynth Biotechnologies (Fuji) and Ajinomoto Bio-pharma Services (AjiBio) to provide product manufacturing in cGMP global manufacturing facilities. The company has completed technology transfer and scale-up consistent with global cGMP standards with both Fuji and AjiBio.
OTLK has also executed a supply agreement for a pre-filled ophthalmic syringe that will provide both ease-of-use for clinicians and add to ONS-5010’s safety profile.
On the regulatory front, Outlook Therapeutics has tentatively been granted an ATC code for ophthalmic bevacizumab by the World Health Organization. Also, SME Entity Status has been granted by the EMA.
Outlook Therapeutics is engaged with several life sciences companies that could result in a strategic partnership and definitive agreement for ONS-5010 as soon as the end of 2020.
Recently, the company announced a joint venture with Syntone Technologies for commercializing ONS-5010 in Greater China.
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