Rishi Singh, MD, presents a case of neovascular age-related macular degeneration and diabetic macular edema demonstrating how the use of ranibizumab biosimilars can yield remarkable anatomical improvements comparable to those expected with reference biologics.
Rishi P. Singh, MD: In this phase of this discussion today, we're going to talk about cases for biosimilars and how they're used in clinical practice. This is a [patient with] neovascular AMD [age-related macular degeneration]…. You can see an 80-year-old [woman] with a macular hemorrhage on the right eye, 20/400 visual acuity, and foveal leakage consistent with either a minimally classic or an occult lesion within the foveal region. This patient has exudative macular degeneration. The left eye is currently 20/40. And what you can see on the OCT [optical coherence tomography] is this picture of a subretinal fluid presentation within this patient for a neovascular AMD. And what we've done in this patient is given the patient a single biosimilar injection of ranibizumab and found a really great anatomical response within 4 to 6 weeks. If you continue to look at this over time, the patient remains really, really stable without significant amounts of fluid. And then, again, goes to 4 to 6 weeks after having a recurrence of fluid over the course of the study. Nonetheless, they continue on therapy. And as you can see from the progress of the actual slides, there is actually a benefit in regards to vision and anatomy in treating with this biosimilar. So in summary, we've improved the patient's vision from 20/400 to 20/40 with the use of biosimilars every 4 to 6 weeks.
The next case in our biosimilar journey will be talking about this patient with diabetic macular edema. You can see the fundus pictures of the right eye demonstrating both abnormal hemorrhages as well as microaneurysms. There is some amount of capillary nonperfusion, but there's no microischemia that can be seen. The visual acuity is 20/60 in the right and 20/40 in the left. And this patient has on the OCT, the presence of diabetic macular edema. Now, granted [this patient’s] vision is still quite good in the side, this patient does meet criteria given the central subfield thickness for their treatment over the course of this trial. Here, you can see the more detailed examination of each of the layers of the retina over time. And we found essentially was that when you gave ranibizumab in the 0.3-mg format for diabetic macular edema, you saw 4 to 6 weeks interval out to 2 months for these patients treated with a biosimilar and clinical practice. When we go farther out, in fact, I find that patients maintaining vision to 20/30 in this right eye after getting a few biosimilar injections, and they really don't have recurrence at any given time that's quite significant other than that they've been able to maintain their vision. So now here's the final OCT with again good visual acuity despite being on a biosimilar for a long, long period of time.
Transcript is AI-generated and edited for clarity and readability.