Abicipar phase 3 data presented at AAO Conference in Chicago: Potential to be the first fixed 12-week anti-VEGF therapeutic
Zurich-Schlieren, October 29, 2018. Molecular Partners AG (SIX: MOLN), a clinical-stage
biopharmaceutical company pioneering the use of DARPin® therapeutics* to treat serious diseases,
today announced that the phase 3 safety and efficacy data of abicipar in patients with neovascular
Age-related Macular Degeneration (nAMD) were presented at the American Academy of
Ophthalmology (AAO) conference in Chicago.
In two global phase 3 studies, called SEQUOIA and CEDAR, a total of more than 1,800 patients with
nAMD were treated with a fixed treatment regimen of either 2 mg abicipar every 12 weeks (2q12) or
every 8 weeks (2q8) following three loading doses, or the comparator, monthly ranibizumab
(Lucentis®).
The data show that both abicipar regimens met the pre-specified criteria for non-inferiority to
monthly ranibizumab for the primary endpoint (defined as stable vision at week 52) in both SEQUOIA
and CEDAR. Additionally, the initial vision gains for abicipar fixed 2q12 and fixed 2q8 were
maintained throughout week 52.
The anatomical data (OCT) on abicipar-treated patients showed reductions of central retinal
thickness (CRT) in all arms in both studies in the same range as for ranibizumab. Overall, the efficacy
endpoints at week 52 showed comparable efficacy with 6-8 injections of abicipar vs. 13 injections of
ranibizumab.
The overall incidence of treatment emergent adverse events was comparable among all three
treatment groups. Abicipar-treated patients had a higher risk of developing intraocular inflammation
(IOI) compared to ranibizumab-treated patients. The majority of IOI were mild to moderate and
were treated with topical corticosteroids.
*) DARPin® is a registered trademark owned by Molecular Partners AG.