The two clinical trials, SEQUOIA and CEDAR, are identical global phase 3 studies designed to assess the efficacy and safety of abicipar compared with ranibizumab in treatment-naïve patients with neovascular age-related macular degeneration (AMD). The primary endpoint measured the proportion of treated patients with stable vision at week 52. In both studies abicipar demonstrated similar efficacy after 6 or 8 injections, compared to 13 ranibizumab injections in the first year of this study.
“Abicipar could transform the way physicians manage AMD with anti-VEGF therapy. Today’s anti-VEGFs were designed for monthly or bimonthly dosing. In the real world, patients have difficulty adhering to the schedule, which places their vision at risk. The adopted treat-and extend approach, while practical, is supported by limited data and in certain cases shows sub-optimal visual outcomes. Treat-and-extend amounts to a compromise for most patients who are unable or unwilling to comply with frequent injections. Abicipar could be the first and only 12- week anti-VEGF treatment that improves visual outcomes in a real world setting for a large number of AMD patients,” said Raj Maturi, MD, Midwest Eye Institute & Associate Professor Ophthalmology, Indiana University School of Medicine.
Very important milestone for Molecular Partners
“We are very excited to see that the most advanced DARPin molecule, abicipar, reaches its primary endpoint in phase 3. This is a very important milestone for Molecular Partners and the DARPin technology in general,” said Patrick Amstutz, PhD, CEO of Molecular Partners. “We are very pleased to see that abicipar can indeed help patients in need with less frequent dosing which was the key point when we generated abicipar in the first place,” added Michael T. Stumpp, PhD, COO of Molecular Partners.
Abicipar pegol is a long-acting potent antagonist of vascular endothelial growth factor (VEGF), which is based on the DARPin technology. Abicipar pegol was licensed to Allergan from Molecular Partners in May 2011.