Roche's new intraocular drug delivery system ranibizumab PDS enters priority review in the United States

Roche's Genentech recently announced that the U.

The FDA is expected to make an approval decision before October 23, 2021

PDS (Port Delivery System) is a permanent, refillable intraocular implant with a size of about a grain of rice, which can continuously deliver customized formulations of ranibizumab within a few months.

PDS can be refilled continuously (once every 6 months).

Dr.

PDS (picture source-PMID: 30946888)

PDS BLA submission, based on the positive results of the Phase 3 ARCHWAY study (NCT03677934)

In addition, the visual results obtained by these patients are consistent with those who received 0.

The safety of PDS in clinical trials has been fully understood and will continue to be closely monitored

Schematic diagram of PDS rehydration operation (retinalphysician.

Neovascular AMD (nAMD) is the main cause of blindness in people aged 60 and over in the world.

Ranibizumab is a vascular endothelial growth factor (VEGF) inhibitor designed to bind and inhibit VEGF-A, a protein that plays a key role in new blood vessel formation and vascular leakage

PDS contains a customized formulation of ranibizumab that has not been approved by regulatory agencies.

By maintaining the therapeutic drug concentration level of ranibizumab by rehydrating twice a year, PDS can provide patients with nAMD with greater certainty of the results in terms of visual gain and maintenance of these gains

In addition to the ARCHWAY study, the PORTAL study is investigating the long-term safety and tolerability of PDS in the treatment of nAMD

Original source: FDA Accepts Application for Genentech's Port Delivery System With Ranibizumab (PDS) for Treatment of Wet Age-Related Macular Degeneration (AMD)