Avedro has announced that patients are now being enrolled in a Phase III trial of an epithelium-on (epi-on) corneal collagen cross-linking procedure designed as a treatment for patients who have progressive keratoconus. You can read the full article here, at Business Wire.
Keratoconus occurs as a result of a person’s cornea (front surface of the eye) gradually becomes more cone-shaped as it thins and bends. This can cause symptoms including light sensitivity and blurred vision. Early on, these problems can often be resolved by using glasses and contact lenses. However, the condition can also progress over many years and may reach a stage where other treatments are needed, such as cornea transplants.
One existing treatment for keratoconus is a surgical procedure known as corneal cross-linking, which is usually designed to make the cornea stronger. It typically involves using ultraviolet light and vitamin B2 to stiffen the cornea by making fibres in it ‘cross-link’ or bind tightly, which is a process that can also occur naturally with age. For some patients, this can prevent keratoconus from getting worse.
The experimental treatment is a novel corneal cross-linking procedure. It will be evaluated in a Phase 3 clinical trial called ACP-KXL-308. A planned 275 patients that have progressive keratoconus are expected to enrol in the randomised study. Of these, two thirds will receive the experimental treatment and one third will be given a placebo. The study is expected to take place in around 20 sites across the US, including Ohio, Utah, Virginia, Pennsylvania, and Massachusetts. Patients who enrol must be between 12 and 55 years old and can be male or female. The study will evaluate both the safety and efficacy of the experimental treatment.