Shares of Ampio Pharmaceuticals (AMPE) rose sharply Monday morning as the company announced positive results from its drug Optina, an oral treatment for diabetic macular edema.
According to the company, the trial’s results concluded that a patient’s body mass index, or BMI, is directly related to the dosage size of Optina. Patients with a high BMI needed higher doses of Optina whereas patients with lower BMI needed smaller doses of the drug.
Diabetic macular edema occurs when complications of diabetes damages the retina of the eyes and causes significant vision loss. Ampio says the only treatments currently available to treat it are laser therapy, or injection or implantation of drugs into or around the eyeball, a process that isn’t approved in the U.S. and Canada.
Ampio’s Chief Regulatory Officer Dr. Vaughan Clift stated that the company will have a pre-IND meeting with the FDA in July as it takes steps to bring the drug to the market.
The company’s Chief Executive Officer Michael Macaluso stated that Ampio Pharma is set to meet all of its clinical goals. In May, the company had a pre-IND meeting with the FDA for osteoarthritis drug Ampion and will have a pre-IND meeting on June 20 with the FDA to review its proposal for Zertane, a premature ejaculation drug for men.
Macaluso stated that having three pre-IND meetings in just three months is a “tribute not only to the quality of the drugs but to the hard work and competence of our clinical team."
The company conducted Optina’s clinical trial at the St Michael Diabetes Hospital in Toronto, Canada.