Drug Development, Market, Results

Stock flies high on Clearside’s PhIII macular edema trial results as drug improves vision

The stock is soaring at Clearside Biomedical $CLSD, a Georgia-based biopharma developing eye drugs that tackle blindness, following news that one of its treatment improved vision in patients.

The results are from a Phase III trial testing the treatment against macular edema associated with inflammation of a part of the eye known as uveitis. Macular edema is the buildup of fluid in the part of the eye known as macula, resulting in distorted vision.

Rahul Khurana

“Typically, uveitic macular edema may persist despite adequate control of uveitis itself, and it is challenging to treat and may persist despite multiple interventions,” said Rahul Khurana, an investigator, in a statement.

Clearside’s product is called suprachoroidal CLS-TA, which is corticosteroid triamcinolone acetonide formulated for administration to the back of the eye.

The company said 47 percent of patients being administered its treatment could see at least 15 letters, compared to 16 percent for patients who underwent a placebo procedure.

The randomized, controlled, and masked trial involving 160 patients met both its primary and secondary endpoints.

“While corticosteroids are the most common treatment for all complications of uveitis, including the associated macular edema, systematic controlled studies of this kind are rare,” Khurana said. “I believe that based on these positive results, and if marketing authorization is obtained from the FDA, suprachoroidal CLS-TA has the potential to become a new paradigm for the treatment of visual impairment associated with macular edema associated with non-infectious uveitis.”

The company plans to submit an NDA for the treatment during the fourth quarter of this year. It’s also “evaluating a number of options” for submissions to regulatory agencies outside the US.

Clearside’s stock is up 66% in pre-market trading. As of press time, shares were selling at $13 per share, up from yesterday’s market close of $7.82.

The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 47,700+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

Visit Endpoints Careers ->