FAQ - Signal12

Frequently Asked Questions

What is Ocular Graft-versus-host Disease?

Ocular Graft-versus-Host Disease (oGvHD) is a chronic disease that can occur after an allogeneic stem cell transplant—typically performed to treat blood cancers or other disorders. In oGvHD, the donor’s immune cells recognize the recipient’s eye tissues as foreign and mount an immune response, leading to inflammation and damage on the ocular surface. Patients xperience severe dryness, redness, pain, and light sensitivity, all of which can significantly affect daily activities and, if left unmanaged, potentially threaten vision. oGvHD affects over 35% of the transplant population resulting in 50,000 US adults facing oGvHD daily with no treatment.

What is the Pro-ocular™ mechanism of action?

Pro-ocular™ is a low concentration of progesterone gel formulation. When applied and massaged twice daily, laterally to the forehead area, it activates a neural pathway that leads to the stimulation of lacrimal and meibomian gland functions. Patients using Pro-ocular in a placebo-controlled clinical trial experienced rapid, significant and durable improvement in signs and symptoms of oGvHD, ocular surface disease, and improved quality of life.

What are the symptoms of GvHD?

Symptoms vary based on how long someone has had the condition, but may include mouth ulcers, abdominal pain, and rash. Treatment can include medication to suppress the immune system, such as steroids.

What is Pro-ocular™?

Pro-ocular™ is a topical gel that treats ocular surface disease by engaging the central nervous system to secrete the body’s own tear film, relieve ocular discomfort, reduce blurry vision, decrease ocular inflammation, and nourish ocular tissue to promote healing.

What is the patient makeup of the Signal12 Phase 2/3 clinical study?

This is a single center, randomized, double mask, placebo-controlled phase two trial with 33 patients and 66 eyes; the randomization of the active to placebo ratio was two to one. All participants were non-pregnant adults with stable chronic oGvHD systemically, none of them had the need to have immunosuppression adjustment at the beginning of the study.

What are the key findings for the Signal12 Phase 2/3 oGvHD clinical study?

Twice daily, topical application of 1% Pro-ocular™ significantly improved ocular symptoms and signs in 10 weeks or less in a group of patients with ocular graft-versus-host disease. Pro-ocular was found to be very effective as 58% of the subjects had symptom reduction of 40% or more in their week 10 assessment.

Is there an FDA-approved treatment for ocular GvHD?

Despite the multiple trials that have been run, attempted, or are currently in process, there is no FDA-approved treatment for ocular GVHD at this time.

Join Our Mission

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

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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.