Abstract
Purpose :
The PDS is an innovative drug delivery system for the continuous delivery of a customized formulation of ranibizumab (RBZ) into the vitreous, approved for nAMD in the US. The Portal extension trial (NCT03683251) is evaluating long-term safety and efficacy of the PDS with RBZ 100 mg/mL (PDS 100 mg/mL) in patients (pts) with nAMD who completed the Ladder (NCT02510794) or Archway (NCT03677934) trials, or will complete the Velodrome (NCT04657289) trial. Interim efficacy data from Portal and long-term pooled safety data from Ladder, Archway, and Portal are reported.
Methods :
In Ladder, pts received PDS (10, 40, or 100 mg/mL) with pro re nata (PRN) refills, or monthly intravitreal RBZ 0.5 mg injections (monthly RBZ). In Archway, pts received PDS 100 mg/mL with fixed 24-week refill-exchanges (PDS Q24W) or monthly RBZ (every 4 weeks). Once moved to Portal, pts receive PDS Q24W from day 1. Efficacy outcomes were assessed for Ladder-to-Portal pts treated with prior PDS 100 mg/mL PRN or prior monthly RBZ. Long-term safety was analyzed using pooled data from all pts who received PDS via optimized surgery procedure in Ladder, Archway, or Portal.
Results :
For Ladder-to-Portal pts, BCVA remained stable from baseline (BL) to month 48 in prior PDS 100 mg/mL PRN (n=59) and prior monthly RBZ (n=41) arms; mean change from BL (letters; 95% CI) was 0.1 (–6.6, 6.8; n=31) and 2.3 (–9.4, 14.1; n=15), respectively. Center point thickness was also stable through month 48. ~95% of pts did not need supplemental treatment before each refill-exchange procedure. The PDS Patient Preference Questionnaire showed that 92% of Ladder-to-Portal prior monthly RBZ pts preferred PDS at week 40 over injections. In the all PDS safety population (n=555; mean follow-up 111 weeks), 137 (24.7%) pts had ≥1 ocular adverse event of special interest (AESI); most common ocular AESIs were cataract (11.4%), vitreous hemorrhage (6.1%), and conjunctival bleb/conjunctival filtering bleb leak (6.3%). Endophthalmitis occurred in 11/555 (2.0%) pts. Most AESIs were mild/moderate in severity.
Conclusions :
Interim results from Portal suggest 48-month maintenance of visual/anatomical outcomes with PDS 100 mg/mL, with PDS preferred to monthly injections. The long-term safety profile of PDS is well characterized, manageable, and reveals no new safety signals.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.