This past November, nearly 9,000 attendees showed up for the American Academy of Ophthalmology (AAO) 2020 Virtual Annual Meeting. During the meeting, biopharmaceutical company Kodiak Sciences Inc. (“Kodiak”) announced that its presentation on KSI-301 would be available as a pre-recorded option. The presentation focused on KSI-301 as a potential treatment for retinal disease such as diabetic macular edema (DME), retinal vein occlusion (RVO), and wet macular degeneration (wAMD). Data for the late-breaker presentation was sourced from the Phase 3 GLIMMER and GLEAM clinical trials. Interested in seeing the full presentation? You can find it on the Kodiak website.
Developed using the Antibody Biopolymer Conjugate (ABC) Platform, KSI-301 is an investigational anti-VEGF treatment for patients with retinal diseases. This first-line treatment is designed to be more potent, effective, and longer-lasting than other anti-VEGF therapies. Currently, the drug is being developed within the KSI-301 Clinical Program. Through this program, Kodiak is evaluating the drug’s safety, efficacy, tolerability, and durability in patients with wAMD, DME, and RVO. Thus far, over 400 patients have received KSI-301 doses.
Researchers are analyzing KSI-301 for patients with previously untreated DME in the Phase 3 GLIMMER and GLEAM clinical trials. Patients receive either KSI-301 or aflibercept, administered intravenously. 450 patients will enroll. The trials will determine the efficacy of KSI-301 as compared to other treatments. During the trials, the primary endpoints are changes in vision from baseline to improvement.
In the Phase 3 BEACON trial, researchers are evaluating KSI-301 for patients with previously untreated macular edema caused by retinal vein inclusion. The trial, which will enroll 550 patients, similarly compares KSI-301 to afilibercept. Following an initial 6-month treatment period, all patients will receive individualized treatment.
Finally, researchers are analyzing KSI-301 for wAMD in the Phase 2b/3 DAZZLE trial. During the trial, enrolling around 550 patients, participants will receive either KSI-301 or afilibercept.
Diabetic Macular Edema (DME)
According to VSP, diabetic macular edema (DME) is:
an accumulation of fluid in the macula part of the retina that controls our most detailed vision abilities—due to leaking blood vessels. In order to develop DME, you must first have diabetic retinopathy, a disease that damages the blood vessels in the retina, resulting in vision impairment.
DME can be focal or diffuse. While the former is caused by abnormal blood vessels, the latter is caused by very thin blood vessels and the swelling of retinal capillaries. Risk factors include diabetes, high blood pressure, and hyperlipidemia. Symptoms of DME include:
- Blurred vision
- Double vision
- Vision loss
Retinal Vein Occlusion (RVO)
The Cleveland Clinic describes retinal vein occlusion (RVO) as:
When the flow of blood from the retina is blocked, it is often because a blood clot is blocking the retinal vein.
Normally, our retinas help us see by converting light into signals and images. We also have arteries which carry blood throughout the body. When retinal vein occlusion happens, blood cannot drain from the retina, causing bleeding and leakages. RVO can be from the central retinal vein or branch retinal vein. Risk factors include high blood pressure, high cholesterol, and diabetes. Symptoms include:
- Blurred vision
- Vision loss, typically in one eye
- Eye pressure and pain
Wet Macular Degeneration (wAMD)
There are two forms of macular degeneration, an eye disease causing vision loss. The dry version is more common, accounting for anywhere from 85-90% of cases. Only 10-15% of individuals receive a diagnosis of wet macular degeneration, a more severe form of the condition. The macula is the central portion of the retina. Researchers believe both environmental and genetic factors cause the macular deterioration of wAMD. Abnormal blood vessels grow under the retinal, leaking blood and fluid, and causing scarring. As a result, patients experience symptoms such as:
- Reduced central vision
- Difficulty recognizing faces or colors
- Decreased brightness
- Blurriness of printed words
- Inability to see fine detail