FDA accepts Genentech's BLA for PDS with ranibizumab to treat wet AMD

Genentech announced that its Biological License Application (BLA) for the Port Delivery System with ranibizumab (PDS) has been accepted by the U.S. FDA for the treatment of wet age-related macular degeneration (AMD).

PDS is a permanent refillable eye implant that continuously delivers a customized formulation of ranibizumab over a period of months, which could reduce the treatment burden associated with frequent eye injections, according to a company news release.

If approved, PDS would become the first and only eye implant with continuous drug delivery offering people with wet AMD another treatment option aside from frequent eye injections, the company stated.

"If approved, PDS would revolutionize wet AMD treatment by providing up to six months of uninterrupted therapy that could potentially improve vision outcomes compared to what we see in the clinic and have a positive impact on patients and caregivers," said Levi Garraway, MD, PhD, Genentech CMO and head of Global Product Development, in a statement.

The FDA is expected to make an approval decision by Oct. 23, 2021.

Genentech's BLA submission stems from positive results from the phase 3 Archway study, which found that — of the participating wet AMD patients being treated with PDS — over 98% did not require additional treatment prior to the refill exchange for six months, according to the release.

Study results show that PDS was found to be well-tolerated with a favorable benefit-risk profile. Its safety profile will be closely monitored in the clinical trial setting.

The Archway study is a randomized, multi-center, open-label phase 3 study analyzing the efficacy and safety of PDS compared to monthly intravitreal injections of ranibizumab 0.5 mg in 418 participants with wet AMD.

All enrolled patients previously received treatment with anti-vascular endothelial growth factor (VEGF) therapy, including at least three injections within six months before participating in the Archway study.

The primary endpoint includes the change in NCVA score from baseline at the average of Week 36 and Week 40, according to the company. The study's secondary endpoints include three criteria: safety, overall change in BCVA from baseline and change from baseline in center point thickness over time.

PDS was shown to be non-inferior and equivalent to monthly ranibizumab, according to the company. Participants received an average of five ranibizumab injections prior to the start of the trial.

Study results show that patients gained an average of 0.2 eye chart letters in visual acuity from baseline compared with 0.5 eye chart letters for the monthly ranibizumab arm.

Further — during the first treatment interval and before the first scheduled refill —1.6% of PDS patients assessed (n=4/246) received supplemental treatment, and 98.4% of patients (n=242/246) did not receive supplemental treatment, according to the company.

PDS was also reported to control retinal thickness as effectively as monthly ranibizumab, with patients in both arms achieving a mean change in center point thickness within 10 μm from baseline at Week 36, the company stated.

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