The Product

Spx81-5

Medical Need

 

Diabetes is generally described as the largest epidemic of the 21st century; in 2015, 9.4% of the U.S. population had diabetes, totaling 30.3 million adults.

Diabetic retinopathy (DR) is a leading cause of blindness, with a prevalence of 35% of diabetics. Existing injectable products cannot be used early-stage, fail to elicit a response in ~30% of patients, and often fail to prevent long-term retinal thinning. The total cost of U.S. retinal vision loss was estimated at $8.7 billion in 2013.

Target Market

 

Globally, there are ~93 million people with DR; over eight million of these patients are in the United States.

The National Eye Institute projects that by 2030, 11.3 million Americans will have DR. Many of these patients require early treatment and prefer an eye drop over regular intraocular injections.

 

Target Patient Segments

  • Patients with early-stage disease
  • Patients who prefer drops over intraocular injections
  • Patients who have failed anti-VEGF therapy

Competitive Advantages

  • Current treatments fail to address early-stage retinal damage. Skyran will test Spx81-5 in early disease.
  • Some patients respond transiently and become resistant to anti-VEGF therapies, while approximately 30% of patients do not respond at all. PEDF therapy may be useful in these patients.
  • Anti-VEGF treatment fails to prevent disease progression; retinal thinning is evident over 2-5 years
  • Anti-VEGF therapies require regular ocular injections (every 4-6 weeks) in a doctor’s office. Our data-to-date show the utility of Spx81-5 in a drop formulation.

STRONG INTELLECTUAL PROPERTY

  • Issued U.S. patent

  • Filed 9/12/2014, issued 4/4/2017

  • Composition of matter for lead compound and five analogs

  • Includes administration by eye drop, foam, gel, or injection

  • Covers use in diabetic retinopathy, retinopathy of prematurity, glaucoma, and more

  • Divisional patent filed 4/3/2017

  • Includes 16 additional analogs

Issues With Current  Therapies:

Requires Injection
Into Eye

Inability to Treat Early-Stage Disease

Declining Effect
Over Time

Failure
Rate

%