KalVista for DME

Diabetic macular edema (DME) is a leading cause of vision loss caused by diabetes.

Diabetic macular edema (DME) is characterized by an accumulation of fluid in the macula of the retina, which is responsible for central, high-resolution, and color vision. Multiple factors contribute to retina blood vessel changes in diabetes, including hyperglycemia, high blood pressure, and abnormal levels of certain growth factors and hormones.

In the United States in 2012, diabetic eye disease (diabetic retinopathy) affected roughly 9.6 million people, with DME occurring in about 10% of patients. Of those, only 15%  receive treatment for their condition.

KalVista’s intravitreal program

Pioneering research by KalVista’s founding scientists identified plasma kallikrein as a novel potential target for the treatment of DME. This research demonstrated that the enzyme plasma kallikrein is increased in the vitreous fluid in eyes of people with DME. In animal models, inhibition of plasma kallikrein led to a reduction in retinal thickening and better processing of visual signals.

eye diagram

Our most advanced compound, an intravitreally administered plasma kallikrein inhibitor known as KVD001, has successfully completed its first in‑human study with DME patients and began a Phase 2 clinical trial in 2017. The clinical trial will evaluate the safety and efficacy of KVD001 in patients who have received previous anti-VEGF therapy yet continue to experience reduced visual acuity and significant edema. The endpoints include safety and tolerability, best corrected visual acuity, central subfield thickness, and level of diabetic retinopathy, following four injections over three months. We expect the trial to complete in the second half of 2019.

In October 2017, we entered into an option agreement with Merck for KVD001 as well as future oral DME compounds based upon plasma kallikrein inhibition. Following completion of the Phase 2 trial for KVD001, Merck will determine whether to acquire KVD001 for later development in DME.

KalVista’s oral program

We continue to take steps in designing an oral plasma kallikrein therapy for DME, based upon the knowledge gained through our oral HAE portfolio and continuing internal research. We believe that an orally delivered therapeutic could provide significant clinical and quality of life benefits to DME patients compared to the current approved DME drugs, which are all delivered via injection.