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June 25, 2021

FDA grants priority review to BLA for Roche’s port delivery system

PDS is a permanent, refillable eye implant that can deliver continuous doses of ranibizumab for up to six months.

The US Food and Drug Administration (FDA) has granted priority review to Roche’s biologics license application (BLA) for a port delivery system with ranibizumab (PDS) to treat neovascular or wet age-related macular degeneration (nAMD).

A permanent, refillable eye implant, PDS can potentially offer continuous delivery of tailored ranibizumab formulation for months. The device’s size is similar to that of a rice grain, Roche said.

Ranibizumab is a vascular endothelial growth factor (VEGF) inhibitor that attaches to and hinders VEGF-A, a protein that is associated with new blood vessel formation and vessel leakiness.

By administering ranibizumab twice a year, PDS could potentially provide better vision gains and sustain those gains for people with retinal diseases, such as nAMD.

Furthermore, this system would lower the need for repeated eye injections and visits to the doctor, thereby decreasing the treatment burden linked to traditional anti-VEGF therapies.

The BLA submitted to the FDA is based on positive preliminary analysis data from the Phase III Archway study.

According to results from the trial, more than 98% of the nAMD patients treated with PDS did not require further therapy for six months before the ranibizumab refill exchange.

Furthermore, the visual outcomes of these subjects were in line with patients who were given monthly eye injections of ranibizumab.

PDS was found to be generally well-tolerated during the trial.

The company noted that the FDA will decide on approval for the system by 23 October.

If approved, PDS would be the first eye implant to offer continuous drug delivery for nAMD patients as an alternative to eye injections.

Roche chief medical officer and Global Product Development head Levi Garraway said: “Anti-VEGF therapy brings significant benefit to people with nAMD, but optimal results require frequent trips to the doctor’s office for eye injections.

“If approved, PDS would transform nAMD treatment by providing up to six months of uninterrupted therapy that could potentially improve vision outcomes compared to what is currently achieved in the clinic.”

The European Medicines Agency has accepted a marketing authorisation application for PDS, and it is currently being reviewed.

Earlier, Roche received Emergency Use Authorisation from the FDA for the use of its cobas SARS-CoV-2 Nucleic acid test in point of care settings.

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