Over 60% of patients in the second year of TENAYA and LUCERNE were on 16 week dosing in the faricimab group.
Two-year data from the phase 3 TENAYA and LUCERNE trials on the efficacy, durability, and safety of faricimab for the treatment of neovascular age-related macular degeneration (nAMD) were reported at the American Society of Retina Specialists 40th Annual Scientific Meeting.
The findings suggest more than 60% of patients with nAMD receiving faricimab could be treated every 4 months while achieving comparable vision gains compared to every two-month aflibercept treatment.
In an interview with HCPLive, presenting author Arshad Khanani, MD, Director of Clinical Research, Sierra Eye Associates, discussed these data, the need for durable agents, ahd what is coming next down the pipeline.
There was an observed comparable visual acuity with both agents with less overall injections needed for faricimab, as well as comparable maintenance of central subfield thickness (CST) between each agent.
"The durability is the most important thing here, as the number of patients going on every 16 week dosing increased significantly," Khanani noted.
Safety was also comparable regarding rates of intraocular inflammation, with no cases of retinal artery occlusion or retinal vasculitis observed in the second year. Vision was also maintained, with over 90% of patients who did not lose three lines of vision, or a ≥50 letter loss.
Khanani noted that the rate of patients gaining 3 lines of vision was good, with the reminder that the trials included patients with better VA compared to traditional nAMD trials.
“When you look at the data, you're not gonna get the visual acuity gains that are similar to older trials because there's a ceiling effect and the same goes for three line gainers, it will be less because you have more patients with better vision that they cannot get three lines of vision,” he said.
Khanani added that durability is the biggest unmet need in both patients with nAMD and retina specialists, making these data hugely important. Outcomes in the real-world are often worse in terms of visual acuity gains compared to clinical trials, which can be directly tied to patients not receiving enough injections.
“The number of injections is directly tied with visual acuity gains,” Khanani said. “From a physician perspective, if we have a more durable agent, we are able to maintain visual acuity longer by decreasing the treatment burden.”
The investigators will continue to collect long-term data, with patients in LUCERNE given the opportunity to rollover into the AVONELLE-X extension study for another 2 years of data collection. Additionally, the TRUCKEE study will investigate the real-world safety and efficacy of faricimab, particularly how switch patients perform with regards to anatomy, vision, and durability.
“We'll continue to generate controlled clinical trial data, as well as the real world data,” he said. So, the patients can benefit from dual inhibition of VEGFA and Ang2, hopefully with more durable efficacy.”
Khanani went on to discuss the underrepresentation of minority patients in clinical trials, noting that it is often an imbalance between real-world practices and clinical trials. He noted that the studies are attempting to correct this imbalance. The ELEVATUM study is investigating faricimab in patients with diabetic macular edema (DME) who are underrepresented minorities
“I think we all need to do a better job to enroll a broader population in clinical trials and of course, access to care leads to under-representation in clinical trials also,” Khanani said.