$Outlook Therapeutics(OTLK)$ Outlook Therapeutics (NASDAQ:OTLK) slumps 37% premarket on robust volume in reaction to topline results from a Phase 3 clinical trial, NORSE-1, evaluating Lytenava (bevacizumab-vikg) (formerly ONS-5010), an ophthalmic formulation of Roche's (OTCQX:RHHBY) cancer med Avastin, in patients with wet age-related macular degeneration (wet AMD).

Investors appear disappointed that Lytenava failed to separate itself from Roche's Lucentis (ranibizumab), approved in the U.S. for wet AMD in June 2006, considering that the latter is already facing biosimilar competition that will constrain pricing and is approved for quarterly dosing, after lead-in, although the less-frequent regimen is not as effective as monthly administration.

There were no statistical differences between Lytenava and Lucentis in the study. Per the primary endpoint, 8% (n=2/25) of patients in the Lytenava arm achieved at least 15 letters in best corrected visual acuity (BCVA) score at month 11 compared to 22% (n=5/23) in the Lucentis arm.

In a subgroup of treatment-naïve patients, 33% (n=2/6) of participants in the Lytenava arm achieved the primary endpoint versus 31% (n=4/13) in the Lucentis arm.

In another subgroup of participants who had baseline visual acuity of less than 67 letters (20/50 or worse), 50% (n=2/4) in the Lytenava arm achieved the primary endpoint compared to 44% (n=4/9) for Lucentis.

不知道会不会影响贝伐的OFF-LABEL使用，或许利好$再生元制药(REGN)$ ?