The filed complaint alleges that defendants made false statements and/or concealed that: (i) there was a lack of substantial evidence supporting the Company's lead product candidate, ONS-5010, as a treatment for wet age-related macular degeneration; (ii) Outlook and/or its manufacturing partner had deficient chemistry manufacturing and controls and other manufacturing issues for ONS-5010, which remained unresolved at the time the ONS-5010 biologics license application (“BLA”) was resubmitted to the U.S. Food and Drug Administration ("FDA"); (iii) as a result of all the foregoing, the FDA was unlikely to approve the ONS-5010 BLA in its present form; (iv) accordingly, ONS-5010’s regulatory and commercial prospects were overstated; and (v) as a result, the Company’s public statements were materially false and misleading at all relevant times.