Frequently Asked Questions

Dry eye disease (DED) is a common condition that occurs when your tears can’t provide adequate lubrication for your eyes. Tears can be inadequate and unstable for many reasons. For example, dry eyes may occur if you don’t produce enough tears or if you produce poor-quality tears. This tear instability leads to inflammation and damage of the eye’s surface. DED affects 38 million people in the U.S., with 18 million diagnosed cases.

Ocular Graft-versus-Host disease (oGvHD) is a condition that occurs when donor bone marrow or stem cells attack the recipient. It can occur at any time after a transplant. However, it’s more common after the marrow has started to make healthy cells. The condition can be mild or severe. oGvHD affects at least 30% to 60% of this population.

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

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.

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.

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.

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.

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.

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Signal12 is raising capital to complete Phase 3 trials and bring Pro-ocular to market. Invest in a future where dry eye sufferers can enjoy lasting relief and improved vision.

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Signal12 Inc.

Signal12 is a clinical-stage dry eye company that develops novel therapies to address ophthalmic diseases. Through three Phase 2 clinical studies, the company’s proprietary topical drug, Pro-ocular™ has demonstrated efficacy in safely and effectively reducing the signs and symptoms of dry eye disease (DED). Pro-ocular™ is the first product for DED to utilize transappendageal delivery, and the only product to treat DED by targeting the ophthalmic branch of the trigeminal nerve. The company has offices in Greenwich, CT and Boston, MA.

Signal12 is actively raising capital to complete Phase 3 clinical trials and bring Pro-ocular™ to market. For information on investment opportunities, please email Neil Edwards at [email protected].

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