Two investigators on Allergan’s (NYSE:AGN) abicipar trials in neovascular age-related macular degeneration (nAMD)—CEDAR and SEQUOIA—have said the company has still not shared full trial data to investigators, noting this as a longer-than-expected delay. Such delays are increasing the existing caution on the overall drug profile given already lingering anxieties surrounding toxicities and abicipar’s MOA. Its ongoing MAPLE trial of a new formulation of abicipar also continues to generate doubt, with abicipar’s fundamental mechanism potentially being the root of safety issues, they added.
After releasing topline data for both trials on July 19, Allergan presented information about treatment-emergent adverse events (TEAEs) and intraocular inflammation at the American Academy of Ophthalmology annual meeting on 26 October (AAO 2018: RET14 Section XI). The presentation did not provide further details beyond incidence, which was disappointing, said an investigator.
A second investigator concurred that he has yet to receive the full data, and researchers within the community had questions surrounding the presentation, namely what defined the serious TEAEs, as well as the visual impact of those AEs. The fact that the safety monitoring committee did not pause the trials is a sign that TEAEs passed scrutiny, but longer-than-usual delays in revealing data to investigators is generating some doubt, the first investigator said.
The pivotal 930-patient CEDAR (NCT02462928) and 946-patient SEQUOIA (NCT02462486) Phase III studies had approximately 20% serious TEAEs, and about 15% intraocular inflammation cases, according to a company investor presentation at AAO. It confirmed cases of retinal vasculitis approximating 2% of intraocular inflammation, or 22 incidences total, compared with 0 in the Roche’s (SIX:ROG) Lucentis (ranibizumab) arm, according to the presentation.
This news service previously reported 31 July that investigators were aware of hemorrhagic retinal vasculitis incidences, which is a severe vision-threatening AE, in the CEDAR and SEQUOIA trials, before they were revealed at AAO.