OcuCure Therapeutics Compound for AMD Demonstrates Efficacy
OcuCure Therapeutics, Inc., a biopharmaceutical company located in Roanoke, specializing in
the treatment of eye disease, reported final results from primate testing of its lead compound OC-10X,
currently under development as a topical eye drop treatment of age-related macular degeneration
(AMD). Results indicated a 43 percent inhibition of ocular neovascularization in primate eyes treated
with OC-10X. The laser-induced choroidal neovascularization (CNV) primate model is considered the
gold standard to demonstrate AMD efficacy.
“This primate efficacy data is very impressive and suggests that OC-10X may have an important role in
the management of exudative AMD in humans,” commented Craig M. Greven, MD, Professor and
Chairman of the Department of Ophthalmology at Wake Forest University, consulting Chief Medical
Officer for OcuCure.
The primate studies were conducted at the Eastern Virginia Medical School T.R. Lee Center for Ocular
Pharmacology. CNV was induced (using laser photocoagulation) in both eyes of eight primates followed
by intravitreal injection of OC-10X in one eye; the other eye served as the control. Two weeks later, a
second injection was administered. Four weeks after the initial laser injury, the areas of CNV lesions
were measured. The 43 percent difference between the smaller CNV lesion in the OC-10X treated eyes
when compared to the larger lesions in the untreated control eyes was statistically significant (t-test,
p=0.025).
“Most other AMD therapies work at the cell signaling level by inhibiting growth factor effects. In contrast, OC-10X works independently of growth factors and thus could provide better long term visual outcome and overall efficacy,” stated Patricia B. Williams, PhD, OcuCure’s Chief Scientif Officer.
This successful primate study follows long-term OC-10X safety studies recently presented at the annual
meeting of the Association for Research in Vision and Ophthalmology, held in Fort Lauderdale, Fla. After
long-term topical administration of six to nine months, no changes in corneal or retinal histology or
function were observed. Electroretinogram (ERG) studies showed that retinal function remained normal
during this long- term testing. Additionally, complete blood counts, clinical blood chemistry panels, and
gross necropsy indicated no evidence of major organ dysfunction.
“We’re encouraged by these findings, because the primate model is a reasonable predictor of human
clinical data,” said OcuCure’s President and CEO Sunder Malkani. “Given the robustness of the efficacy
and safety data, coupled with the unique properties of OC-10X, OcuCure is an attractive opportunity,
with the potential to change the AMD therapeutic landscape.”
OC-10X is also being evaluated for the treatment of diabetic retinopathy (DR).
