Lysoclear, Inc. is an intellectual property holding company for LYSOCLEAR, a pre-clinical drug candidate under development by Ichor Therapeutics for the treatment of age-related macular degeneration and Stargardt’s macular degeneration.
Ichor Therapeutics is a pre-clinical biotechnology company located in rural LaFayette, NY. The company has several intramural research programs that broadly focus on therapeutic interventions for age-related disease. Ichor is eager to engage collaborators in industry and academia who share its vision of delivering next generation therapies for the illnesses of aging.
Age-related macular degeneration (AMD) is the leading cause of vision loss among people over the age of 50, affecting 20 million Americans. The disease is caused by damage to the macula, a part of the retina that is responsible for central vision. The advancement of AMD is slow, and manifests as a gradual loss of central vision in one or both eyes. In later stages of the disease, secondary pathology such as retinal detachment or hemorrhage may occur.
There is no known cure for AMD. Avoiding smoking, the AREDS vitamin formulation, and a healthy lifestyle can reduce risk of disease and progression. Advanced AMD may be treated with injections, photodynamic therapy, or laser surgery.
In rare cases – one in 20,000 – macular degeneration is diagnosed in children and teenagers. Of those cases, the most common cause is Stargardt macular degeneration, named for Karl Stargardt, a German ophthalmologist who first reported a case in his practice in 1901.
Sometimes called Stargardt’s disease, Stargardt affects both eyes and develops sometime between the ages of six and twenty, when kids notice difficulties in reading or adapting to bright light. The cause and treatments of the disease in young people are different from those of age-related macular degeneration. Stargardt disease is the result of a gene called ABCA4 and is usually a recessive trait. When both parents carry the ABCA4 mutation, there is a 25 percent chance their children will have Stargardt disease.
With the passing of the Orphan Drug Act in 1983, the FDA established the Office of Orphan Product Development (OOPD), which gives incentives to biotech companies to develop promising products for the diagnosis, treatment, and cure of rare diseases.
Orphan Drug Status provides tax reductions and the exclusive rights to the cure for a specific condition for a period of seven years post-approval. It encourages companies to enter a market where high costs of drug development are less likely to be recouped quickly, due to the smaller pool of individuals needing the cure.
Drug mechanism of action and successful removal of toxic vitamin A aggregates have been demonstrated. LYSOCLEAR is now being evaluated in pre-clinical animal models for safety and efficacy. The company expects to be prepared to begin human clinical trials in 2018.