Revolutionizing Ocular Health

We are a clinical-stage ophthalmic pharmaceutical company developing first-of-a-kind patented technologies that enable existing drugs to act through unique neural pathways.

Introducing Pro-ocular™

Our Breakthrough Therapy for Treating ocular Graft-versus-Host Disease (oGvHD) without the hassle of Eye Drops

Built for ocular-Graft versus-Host Disease (oGvHD)

Pro-ocular™ is specifically made to treat severe pain, dryness, and inflammation in the eyes of patients with oGvHD, a chronic disease that affects more than 50% of people who get an allogeneic stem cell transplant.

No Approved Treatment Options

Over 50,000 US adults face debilitating pain daily because no approved oGvHD treatment options exist. Pro-ocular™ (if approved) may be the only drug approved by the FDA to treat this chronic orphan disease.

Innovative Forehead Delivery

Unlike eye drops or ointments, Pro-ocular™ is applied to the forehead and gently massaged into the skin. This remote application aims to stimulate tear production by signaling along the ophthalmic branch of the trigeminal nerve.

Patents Secured

Countries Convered

Restoring Eye Health

By activating natural tear production and reducing ocular surface inflammation, Pro-ocular™ may help restore healthier tear film and support overall ocular surface integrity. In multiple cases, patients who were previously thought to be unacceptable surgical candidates were able to undergo cataract surgery successfully after Pro-ocular™ treatment.

Urgent Unmet Need
Pro-ocular is the only treatment addressing oGvHD, a devastating ocular condition affecting 50% of bone marrow transplant patients. The condition causes pain, corneal deterioration, and in severe cases, blindness.
Phase 3 Ready Blockbuster
In February 2025, the FDA accepted our Phase 3 study design during a Type C meeting with no requests for additional studies or submissions. If we duplicate our Phase 2 results, we have a high likelihood of FDA approval.

Clinically Demonstrated Results & Safety Profile

In Phase 2 clinical trials, particpants reported rapid relief of ocular discomfort, which was maintained over 2.25 years of use. Across studies in both oGvHD and autoimmune diseases, Pro-ocular™ was well-tolerated, with no drug-related serious adverse events.

The Harvard Medical School Mass Eye & Ear study showed a 38% improvement in both signs (e.g., corneal staining) and symptoms (e.g., dryness, discomfort) of oGvHD, with sustained benefits through 117 weeks, with some patients reversing corneal damage.

00a0bc_3914b938333c40a8879f3270eb96aba2~mv2-1

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.