Phase II trials for Genentech’s implantable drug delivery system for ranibizumab have proved to be safe and effective, potentially opening up a new treatment option for those with wet age-related macular degeneration (AMD).
The implant is slightly larger than a grain of rice and is refillable, with Genentech noting that the majority of patients needed a refill after six or more months of having the port delivery system (PDS) implanted.
A spokesperson for Genentech conferred what the advantages of this form of delivery are over standard treatment of care: “People with AMD may need as often as monthly eye injections with the current standard of care, anti-VEGF [vascular endothelial growth factor] therapy, a burden that can lead to under-treatment of AMD and, potentially, less than optimal vision outcomes.”
The spokesperson explained that the PDS can be implanted in the eye in approximately 30 minutes and is designed to deliver a continuous supply of ranibizumab.
In the Phase II trial, this form of drug delivery was found to be equally as effective as injections directly into the eye. The spokesperson noted that it could “potentially optimise clinical outcomes in the real world” – though further work will need to be done in the clinic to prove that it offers outcomes beyond standard treatment.
As such, the next stage for research will be to continue into Phase III, with trials expected to begin later in 2018.
Though injections directly into the eye, as in current standard of treatment, is a difficult prospect for some patients, an implant inserted into the eye may also prove a barrier to uptake.
However, the spokesperson confirmed that the surgical procedure and the refill process were “well tolerated” by patients in the trial.
With biosimilars being readied as competitors to Lucentis (ranibizumab), the advantage of having a patented method of delivery could be of benefit to Genentech as it looks to hold onto the US market. The PDS uses a special formulation of ranibizumab that has yet to be approved by the FDA.