Pro-ocular™

Clinical Trials

Demonstrated Efficacy, Safety and Adherence

Pro-ocular™ Phase 2 oGvHD Placebo Controlled Study

n=33 subjects (active:placebo, 2:1)
10-week randomized, placebo controlled then subjects remained on active treatment for the remainder of 117 weeks or 2.25 years
At week 10, placebo subjects cross-over to active drug
Conducted at Harvard University affiliated Massachusetts Eye & Ear and Dana-Farber Cancer Institute
The key Endpoints are validated, FDA-accepted

Pro-ocular™ Phase 2 Dry Eye Disease Clinical Study

Double-blind, parallel design conducted at Ora CRO (Andover, MA)
2 week study, subjects with dry eye syndrome, n=72 total
n=24 per arm (1% Pro-ocular™, 0.25% Pro-ocular™, Placebo)

U.S. Clinical Studies

In the U.S., our groundbreaking drug, Pro-ocular™, showed statistically significant promise in treating oGvHD and dry eye.

Collaborations

Collaborations with renowned institutions, such as Harvard University Mass Eye and Ear and Dana-Farber Cancer Institute, underscored Pro-ocular’s transformative impact, providing relief to patients suffering from ocular Graft-versus-Host Disease (oGvHD).

Patient Outcomes

Patients experienced notable pain relief, improved vision, and enhanced quality of life, with some even undergoing successful cataract surgeries after months of Pro-ocular™ treatment.

Key Data: Harvard Mass. Eye and Ear Phase 2 Study

Published Study

If you’d like more information about our clinical data, get in touch today.

Pipeline

Focus on Phase 3 Clinical Trials

Novel Forehead Delivery Creates Basis for Unique Pipeline

Pro-ocular™ treats all forms of Dry eye: mild, moderate and severe.

Join Our Mission

Signal12 is planning to facilitate Phase 3 clinical trials in 2025 and bring Pro-ocular™ to market.

Pro-ocular™
Clinical Trials
Company
Leadership

Signal12 Inc.

Signal12 is a Phase 3-ready ophthalmic drug company. Our proprietary topical drug, Pro-ocular™, has proven safe and effective in Phase 2 clinical studies, demonstrating significant reductions in the signs and symptoms of ocular Graft-versus-Host Disease (oGvHD)—a chronic, debilitating condition following an allogeneic stem cell transplant. Pro-ocular™ is the only effective treatment for oGvHD, employing transappendageal delivery to precisely target the ophthalmic branch of the trigeminal nerve

Signal12 is actively raising capital to complete its Phase 3 clinical trials and bring Pro-ocular™ to market. For information on investment opportunities, please email Neil Edwards at [email protected]. The company has offices in Greenwich, CT and Boston, MA.