In late May 2023, clinical-stage biotechnology company AiViva Biopharma Inc. (“AiViva”) shared via news release that the company had launched a Phase 1 clinical study evaluating AIV007 for diabetic macular edema (DME) and wet age-related macular degeneration (wet AMD). So far, the first cohort in the study has already received doses of this medication.
Studying Wet AMD and DME
On the AiViva website, the company describes AIV007 as:
a novel formulation using our JEL™ Technology designed for prolonged drug release. AIV007 targets multiple pathways including VEGFR, PDGFR, and FGFR to address neovascularization and fibrosis, and it also modulates TGFβ1 mRNA expression and TGFβ1 levels to reduce collagen production and scarring.
In animal models, AIV007, which is delivered intravitreally, was safe and relatively effective in reducing neovascularization (the formation of new blood vessels that can lead to swelling and scarring).
AiViva hopes to see similar results in the Phase 1 study. This dose-escalation trial will enroll up to 24 individuals with either DME or wet AMD. After receiving AIV007, the patients will then be followed for a 6-month period. In addition to determing whether AIV007 is safe to use, tolerated by patients, and effective in reducing symptoms, the trial seeks to determine whether AIV007 has the potential to protect, preserve, or even improve visual acuity.
A Better Understanding of These Conditions
Diabetic macular edema (DME) is an eye condition that can occur as a complication of diabetes. High blood sugar damages blood vessels in the eye, causing a condition called diabetic retinopathy that is characterized by vision loss. The blood vessels then leak fluid into the macula, causing swelling and scarring. Once this occurs, it is considered DME. People with DME may experience blurred or double vision; they may also have more “floaters” in the eye that normal.
Wet AMD occurs in only 20% of people with macular degeneration; the remaining 80% of cases are considered dry AMD. However, all cases begin as dry AMD. Doctors aren’t sure why some people progress to the wet form. Wet AMD happens either when fluid leaks from the choroid or abnormal blood vessels grow from the choroid into the macula. If you are Caucasian, have a family history of wet AMD, smoke cigarettes, are older in age, or are obese, you have a higher chance of developing wet AMD. Symptoms often appear suddenly and progress very quickly. People with wet AMD may have a harder time adjusting to low light, reading, or recognizing people. Additionally, they may experience visual distortions, issues with central vision, and blurred vision. If treated early enough, wet age-related macular degeneration can be stopped and vision can be preserved.
