Genentech/Roche is presenting data from its ophthalmology franchise, including Lucentis (ranibizumab), the investigational Port Delivery System with ranibizumab (PDS) and faricimab at the American Society of Retina Specialists (ASRS) annual meeting on July 26-30 in Chicago, Illinois.
Notably, the companies will be presenting key outcomes of the phase 2 Ladder study of the PDS in wet AMD that informed the design of the phase 3 Archway (NCT03677934) clinical trial. The PDS is a first-of-its-kind refillable eye implant designed to continuously release a special formulation of ranibizumab over a period of months.
Port Delivery System with Ranibizumab (PDS) Presentations
- Title: Port Delivery System With Ranibizumab (PDS): Key Outcomes From the Ladder Phase 2 Trial That Supported Archway Phase 3 Study Design in nAMD
Presented by Arshad Khanani, MD, on Saturday, July 27, 11:52–11:58am CT; Paper Session: AMD Neovascular Part II Symposium; Hyatt Regency Chicago
o This presentation identifies key results from the phase 2 Ladder study that informed the clinical trial design of the phase 3 Archway study evaluating the PDS for the treatment of wet AMD.
o In Ladder, 80 percent of patients receiving the PDS 100 mg/mL were able to go 6 months or longer before needing a refill of the implant. In addition, patients in the PDS 100 mg/mL group had similar changes from baseline in visual acuity, central foveal thickness (CFT), choroidal neovascularization (CNV) area and lesion size at month 6 compared to patients receiving monthly ranibizumab treatment.
o These comparable visual and anatomic results between the PDS 100 mg/mL and monthly ranibizumab treatment support the 24-week fixed refill schedule in the Archway study.
- Title: Optimization of the Port Delivery System With Ranibizumab (PDS) Implant Insertion Procedure in the Ladder Phase 2 Trial
Presented by Mark Wieland, MD, on Saturday, July 27, 2:59–3:05pm CT; Paper Session: Surgical Techniques and Maneuvers Symposium; Hyatt Regency Chicago
o This presentation will review how the surgical procedure created to implant the PDS was optimized during the phase 2 Ladder study to improve surgical outcomes in patients with wet AMD.
o Through this surgical optimization, the rates of vitreous hemorrhage was reduced significantly and a robust investigator training program has been implemented for the phase 3 Archway trial to ensure procedural consistency and prioritize patient safety.
- Title: The Average Patient Does Not Enter Your Office: What Can We Learn About Treating nAMD From Individual Patient Responses
Presented by David S. Boyer, MD, on Saturday, July 27, 12:04-12:08pm CT; Paper Session: AMD Neovascular Part II Symposium; Hyatt Regency Chicago
o Through individual patient responses from the phase 3 HARBOR study, authors examined the differences between wet AMD patients who regained normal vision and those who remained visually impaired after treatment with ranibizumab.
o This analysis compared the changes from baseline in Best Corrected Visual Acuity (BCVA) and central subfoveal thickness (CST) according to whether patients achieved 20/40 or better vision, and the presence of macular atrophy, at 24 months. The correlation between anatomic and vision outcomes and the differences between patients with 20/40 vision or better or worse than 20/40 vision were analyzed.
o The analysis found there was no correlation between a reduction in CST and BCVA gain at month 24 in ranibizumab-treated patients. In addition, the presence of subretinal fluid at baseline was associated with better vision outcomes in patients treated with ranibizumab.
- Title: Diabetic Retinopathy Progression In The Absence Of Therapy: An Analysis Of Untreated Fellow Eyes In RIDE and RISE
o This analysis of the phase 3 RIDE/RISE clinical trials compared the progression of diabetic retinopathy severity between study (sham- and ranibizumab-treated) eyes and untreated eyes during the first 24 months of the trials.
o Researchers found that, in the absence of treatment, almost 30 percent of eyes with moderately severe to severe nonproliferative diabetic retinopathy (NPDR) progressed to proliferative diabetic retinopathy within two years; however, almost 90 percent of eyes treated with monthly ranibizumab achieved a 2-step or better improvement in diabetic retinopathy severity.
o This study highlights the importance of early treatment for diabetic retinopathy to delay diabetic retinopathy progression and improve disease severity.
- Title: Simultaneous Inhibition of Ang-2 and VEGF-A With Faricimab in DME: Additional Anatomical and Durability Outcomes From the BOULEVARD Phase 2 Trial
Presented by Vrinda Hershberger, MD, on Tuesday, July 30, 11:57 am–12:03 pm CT; Paper Session: Diabetic Retinopathy Part II Symposium; Hyatt Regency Chicago
o This analysis of the phase 2 BOULEVARD study examines anatomic and durability outcomes that support extended dosing intervals for faricimab for the treatment of DME.
o In BOULEVARD, anti-VEGF treatment naïve DME patients were randomized to receive faricimab, either 1.5 mg or 6.0 mg, or ranibizumab given every four weeks for 20 weeks with change in visual acuity measured at week 24. The study also included a 16-week off-treatment observation period to assess sustained efficacy of faricimab.
o This analysis found that treatment with faricimab 6.0 mg resulted in improved visual acuity and anatomic outcomes compared to treatment with ranibizumab in DME patients. Faricimab showed the potential for longer time between treatment during the BOULEVARD off-treatment observation period. Additional analyses of faricimab durability during this off-treatment period will be presented.
o The ongoing phase 3 YOSEMITE and RHINE studies of faricimab in DME will assess an extended dosing interval.