Published

Concomitant use of oral vitamins or minerals was permitted in pivotal clinical trials of ACP; however, no dedicated analyses were performed to evaluate potential effects on safety or efficacy.

  • ACP’s safety and efficacy were evaluated in two pivotal randomized, double‑masked, sham‑controlled trials, GATHER1 (n = 286) and GATHER2 (n = 448), in patients with geographic atrophy secondary to age-related macular degeneration.1,2 
  • Concomitant oral vitamin/mineral use was permitted in the GATHER clinical program; no subgroup analyses were performed, and brand names/formulations were not collected.3

Table 1. Patient vitamin use in GATHER13

Table 2. Patient vitamin use in GATHER23

  1. Jaffe GJ, Westby K, Csaky KG, et al. C5 Inhibitor Avacincaptad Pegol for Geographic Atrophy Due to Age-Related Macular Degeneration A Randomized Pivotal Phase 2/3 Trial. Ophthalmology. 2021;128(4):576-586. https://dx.doi.org/10.1016/j.ophtha.2020.08.027.

  2. Khanani AM, Patel SS, Staurenghi G, et al. Efficacy and safety of avacincaptad pegol in patients with geographic atrophy (GATHER2): 12-month results from a randomised, double-masked, phase 3 trial. Lancet. 2023;402(10411):1449-1458. https://dx.doi.org/10.1016/s0140-6736(23)01583-0.

  3. Data on File.

find-my-msl

Find My MSL

Medical Science Liaisons are available to help answer your scientific questions.

submit

Submit an Inquiry

For any medical inquiries, please submit your question online to Astellas Medical Information or call or fax your inquiry.

Astellas Phone: 1-800-727-7003

Fax: 1-877-829-7942

adverse

Report an Adverse Event or Product Complaint

Report adverse events and product complaints to Astellas or FDA MedWatch.

Astellas Phone: 1-800-727-7003

FDA MedWatch: 1-800-FDA-1088

Hours: M–F, 8 AM–4:30 PM (CT)