Clearside BioMedical Inc. said its drug suprachoroidal CLS-TA improved vision in patients with a certain type of eye disease when used in combination with Regeneron Pharmaceuticals Inc.'s blockbuster medicine Eylea.
The Alpharetta, Ga.-based biopharmaceutical company said the phase 2 trial, named Tybee, evaluated CLS-TA that was administered to the back of the eye via the suprachoroidal space — the space between the choroid and the outer protective layer of the eye known as the sclera — in combination with Eylea and compared it against a combination of Eylea plus a mock suprachoroidal procedure.
The new combination is meant to treat patients with diabetic macular edema, which is caused by diabetic retinopathy, a condition in which diabetes affects vision and can lead to blindness. Macular edema occurs when damaged blood vessels cause a buildup of fluid in the macula, a part of the retina that controls vision, and can cause visual distortion.
Clearside said the trial met its main goal of improvement of visual acuity over six months from the start of the treatment; the results were measured by administering an eye test. Patients who received CLS-TA and Eylea gained an average of 12.3 letters on a particular test scale compared to 13.5 letters in the Elyea-alone control arm.
The trial also met a secondary goal of reduction in thickness of the retina. The company said 93% of patients in the combination arm had a greater than 50% reduction in excess thickness at six months, compared to 73% of patients in the control arm.
Clearside said suprachoroidal CLS-TA used with Eylea was generally well-tolerated, with no treatment-related serious adverse events.
The company reported in March that the eye treatment significantly improved the vision of certain patients with macular edema in a late-stage study.
