Roche subsidiary Genentech has reported positive, top-line data from a Phase II clinical trial (LADDER) conducted to assess its Port Delivery System with ranibizumab (PDS) in wet age-related macular degeneration (AMD) patients.
PDS is an investigational refillable eye implant intended to minimise the need for patients to visit an ophthalmologist for treatment.
The device is implanted through a surgical procedure and can be refilled using a customised needle during a minimally invasive office-based approach.
Results showed that most of the LADDER trial subjects were able to remain six months or longer without requiring a refill, following the PDS implantation.
In the high-dose PDS group, vision outcomes were found to be similar to monthly ranibizumab eye injections and sustained throughout the study period.
Genentech chief medical officer and Global Product Development head Sandra Horning said: “We are highly encouraged by these results and the potential of the PDS, our first implantable, drug delivery programme.
“With the PDS, we have an opportunity to make a positive impact by helping to potentially eliminate the burden of frequent treatments for people with wet AMD.”
The multi-centre, randomised, interventional, active treatment-controlled LADDER trial assessed the safety and efficacy of PDS carrying 10, 40 or 100mg/mL of ranibizumab in 243 subjects at around 50 US sites.
It was observed that 80% of patients implanted with the device delivering 100mg/mL dose were able to go six months or longer until their first refill, while the proportion was 71.3% with 40mg/mL and 63.5% in case of 10mg/mL.
The trial also evaluated secondary endpoints such as vision and anatomic outcomes compared to monthly intravitreal ranibizumab 0.5mg injections.
Genentech is planning to commence a Phase III clinical development programme of PDS later this year.