TOKYO — An implantable device that provides sustained delivery of ranibizumab showed potential for optimal visual and anatomical outcomes, according to one speaker.
The device, a port delivery system (PDS) produced by Genentech, addresses the need for successful treatment and reduced burden of frequent visits to the physician’s office, Roman Rubio, MD, head of ophthalmology at Genentech, said at the World Ophthalmology Congress.
“It is a refillable, non-biodegradable, long-term drug delivery implant aimed at providing sustained drug release. It is placed in the pars plana beneath the conjunctiva using a standard surgical technique through a 3.2-mm incision and requires no scleral sutures. Refill is performed as-needed by injection,” he said.
A phase 1 uncontrolled trial was performed in 20 treatment-naïve patients with neovascular age-related macular degeneration. The device was placed and filled with 500 µg of Lucentis (ranibizumab, Genentech), 250 µg as an intravitreal bolus and 250 µg released in a sustained manner over time. Patients were evaluated monthly for 1 year, and the implant was refilled according to predetermined visual acuity and optical coherence tomography re-treatment criteria.
“The visual acuity curve was very similar to that observed in the MARINA and ANCHOR with monthly treatment,” Rubio said. “The majority of patients had a significant VA gain and stable reduction in macular thickness and CNV leakage.”
Three adverse events — one case of endophthalmitis and two cases of persistent vitreous hemorrhage — were attributed to the device placement procedure.
Preplanned explantation was performed in six patients, and no damage or alteration was observed in the device or surrounding tissue. In 14 patients, the device was left in place for a further 2 years with equally good results. Follow-up visits were performed every 3 months.
Disclosure: Rubio is group medical director at Genentech.