Abicipar is a long-acting anti-VEGF therapeutic candidate, which was invented by Molecular Partners and initially licensed to Allergan in 2011. The program has been through two positive Phase 3 studies, CEDAR and SEQUOIA, which supported the non-inferior efficacy of the abicipar quarterly dosing regimen to maintain vision gains with more than 50 percent fewer injections versus ranibizumab (13 vs. 6) dosed monthly in the first year.
In June 2020, a Complete Response Letter was issued for the Biologics License Application for abicipar pegol, indicating that the rate of intraocular inflammation observed following administration of abicipar pegol resulted in an unfavorable benefit-risk ratio in the treatment of nAMD (AMD), and that additional work would be required to demonstrate a lower rate of ocular inflammation than what was previously seen in the Phase 3 studies. In 2021, Molecular Partners is to regain global rights to abicipar from AbbVie and is determining appropriate next steps for the program.
Current anti-VEGF treatments are injected on a monthly, bi-monthly and — only in a subset of patents — on a quarterly basis. Less frequent injections are a key advantage for patients.
An anti-VEGF with high potency and long ocular half-life would allow less frequent injections compared to standard therapies.
Abicipar has been engineered for a long half-life in the eye and highest potency. Phase 3 results have demonstrated that quarterly injections are equivalent to monthly injections of Lucentis®.