Outlook Therapeutics, Inc. OTLK
Outlook Therapeutics, Inc. (Nasdaq: OTLK) is an ophthalmology drug developer. Its lead program, LYTENAVA (bevacizumab-vikg), is marketed for wet age-related macular degeneration. Its next catalyst on record is LYTENAVA: US commercial launch (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: LYTENAVA — US commercial launch (Q4 2026). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| LYTENAVA | wet AMD | antibody | Approved |
Recent results and decisions
- Aug 14, 2026approval FDA approval of LYTENAVA (the only FDA-approved ophthalmic bevacizumab) for wet AMD is highlighted; approval date not stated in the release text; US launch planned before end of calendar 2026.
The Company continues to advance preparations for the U.S. commercial launch of LYTENAVA, the only FDA-approved ophthalmic bevacizumab for the treatment of wet age-related macular degeneration (wet AMD).
Filing - Jul 24, 2026approval FDA approved LYTENAVA (bevacizumab-vikg) for neovascular AMD, the first FDA-approved ophthalmic bevacizumab.
today announced that the U.S. Food and Drug Administration (FDA) has approved LYTENAVA™ (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (nAMD), commonly known as wet AMD.
Filing - Jun 16, 2026accepted FDA accepted the resubmitted ONS-5010 BLA as a Class 1 review with a PDUFA target action date of July 29, 2026.
The Company has been informed that the resubmission is a Class 1 review, with a PDUFA target action date of July 29, 2026.
Filing
3 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other approved ophthalmology companies
- Harrow, Inc. HROW
- LENZ Therapeutics, Inc. LENZ
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.