What is Ocular Graft-versus-host disease 

Graft-versus-host disease (GvHD) 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. Ocular GvHD affects at least 30% to 60% of this population.

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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. 

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What is Progesterone? 

Progesterone is an endogenous steroid and progestogen sex hormone involved in the menstrual cycle, pregnancy, and embryogenesis of humans and other species. It belongs to a group of steroid hormones called the progestogens and is the major progestogen in the body.

 

What is Pro-ocularTM?

Pro-ocularTM 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.

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What is the Pro-ocularTM mechanism of action? 

Pro-ocularTM, a low concentration of progesterone gel formulation (1% or 0.5%), 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-ocularTM in placebo-controlled clinical trials experienced rapid, significant and durable improvement in signs and symptoms of ocular surface disease and improved quality of life.

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What is the patient makeup of Glia’s Phase II/III clinical study? 

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

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What are the key findings for Glia’s Phase II/III clinical study? 

Topical application of 1% progesterone twice a day significantly improved ocular symptoms and signs in 10 weeks or less in a group of patients with ocular graft-versus-host disease. It is very effective as shown, 67% of the subjects had symptom reduction of 50% or more at least in one of their two eyes in the active group versus only 27 were found in the placebo group at 10 weeks after the treatment.

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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.