Update on TENAYA and LUCERENE clinical trials

During a conversation at the American Academy of Ophthalmology’s 2022 annual meeting in Chicago, Rishi Singh, MD, offered highlights of the two-year results of faricimab in a pair of phase 3 clinical trials.

Video transcript

Note: This transcript has been lightly edited for clarity.

Rishi Singh, MD, Cleveland Clinic Florida, Martin Health: Hi, my name is Rishi Singh. I'm staff physician and president of Cleveland Clinic Martin Hospital in Cleveland Clinic Florida. And it is my pleasure to be here this year as American of Ophthalmology meeting in Chicago, where I am going to be discussing the two-year results from TENAYA and LUCERNE.

These were the phase 3 clinical trials for faricimab. Faricimab is a new treatment for neovascular AMD which was released earlier this year. And we have found in the two years of data really insightful results with regards to what we can see regarding the efficacy and safety of this drug over that period of time.

One of the things we learned, in my paper that I'm presenting at this meeting, is that there is still the same incredible durability of this drug within the second year of the trial. On average, 80% of patients were able to be maintained on acute 12 week or longer durability during the course of those two years. And that gave us some reassurances that maybe in the first year, we weren't necessarily extending them too far. We actually seem like we are extending them properly.

In addition, we found that many patients were able to maintain their vision and maintain their OCT thickness, with a good stability, no significant fluctuations in the OCT over time despite this extended durability, and far fewer injections than we saw with the aflibercept arm and then the study in the second year as well.

In addition, we looked at the safety of faricimab in the second year the trial offered no new insights with regards to safety. The drug had very, very low rates of interest, inflammation and any other events and nothing that was of concern compared to the aflibercept arm in the course of the trial.

So, in summary, we found that there was an incredible durability of faricimab within the second year of this study. Again, it showed anatomical benefit to these patients despite less frequent dosing. And again attacks one of the most significant issues that we all face as retina specialists, which is that we have patients that unfortunately, do not have the ability to come back to see us each month and each time for their injections. This durability effect really prevents that patient from falling off the curve and losing vision over time. Thank you very much for watching.