Roche eye implant gets FDA application go-ahead
Roche announced that the US Food and Drug Administration (FDA) had accepted its Biologics License Application (BLA) under Priority Review. The application sees Roche seeking marketing approval for the delivery of ranibizumab by Port Delivery System (PDS) to treat neovascular or ‘wet’ age-related macular degeneration (nAMD).
PDS is a permanent refillable eye implant, which is approximately the size of a grain of rice. The device is able to deliver a continuous therapeutic dose of ranibizumab to the eye.
According to a Roche spokesperson, PDS is refilled every six months through a specifically designed needle, which introduces the treatment directly into the device and simultaneously withdraws any remaining solution from a prior refill.
Should it be approved, the delivery device would offer an alternative to eye injections, which are typically delivered once a month. With the PDS, doses are more infrequent and the spokesperson stated that this could “address less than optimal vision outcomes and unnecessary vision loss that can result from under-treatment.”
Roche stated that the formulation of ranibizumab is customized from that used in injection, known as Lucentis. The spokesperson outlined that the difference is the higher concentration used in the PDS, which equates to 100mg/mL compared with 10 mg/mL for the injection.
The FDA is expected to make a decision on approval by October 23, 2021. The company also has also received validation for Marketing Authorization Application (MAA) with the European Medicines Agency (EMA), which is currently under review.
Looking for delivery alternatives
Roche is currently examining the safety and efficacy of PDS in the treatment of other age-related macular degeneration conditions. This includes two Phase III trials for the treatment of diabetic macular edema (DME), and diabetic retinopathy without DME.
When asked if Roche is exploring the delivery system for other treatments, the spokesperson stated, “PDS is a platform technology that could potentially be adapted for use with other Roche pipeline molecules.” However, as yet, no other agents have been studied for delivery in patients, they added.
The aim of finding other delivery methods for biologics has been area of interest for Roche for some time, particularly when a product is facing patent expirations. The company is exploring a number of alternative delivery systems for some of its core products, such as its partnership with Halozyme for Herceptin Hylecta (trastuzumab and hyaluronidase-oysk).
