Phase I Study Assessing the Ocular and Systemic Safety and Tolerability of OC-10X
Status:
Completed
Trial end date:
2013-06-01
Target enrollment:
Participant gender:
Summary
The present study is intended to evaluate the safety and tolerability of topical OC-10X
Ophthalmic Suspension in healthy human subjects. OcuCure Therapeutics, Inc. (Roanoke, VA) has
developed a lead compound, known as OC-10X, which is a selective tubulin inhibitor under
development for the treatment of Proliferative Diabetic Retinopathy (PDR) and Age-related
Macular Degeneration (AMD). When administered as a topical eye drop, OC-10X has demonstrated
both anti-angiogenic (inhibition) and angiolytic (regression) properties in animal models of
AMD. Unlike other therapies, OC-10X provides the efficacy of a vascular targeting agent
without the traditional toxicity and works downstream independently of growth factors. As
demonstrated by OcuCure's preclinical data, tubulin inhibition using OC-10X has promise as a
new therapeutic approach. PDR is a major cause of blindness in adults and is also caused by
the growth of abnormal blood vessels. These new blood vessels are fragile and may hemorrhage
into the vitreous. PDR affects up to 80% of all diabetics who have had diabetes for 15 years
or more. If administration of OC-10X is well tolerated as a topical eye drop and is well
tolerated systemically, then OC-10X will have the potential to provide benefits to patients
with ocular diseases associated with angiogenesis.