Clearside announces positive Phase II results in win for back-of-the-eye drug delivery

Courtesy of National Eye Institute, NIH

Most drugs are injected into the eye's intravitreal chamber, but Alpharetta, GA's Clearside believes that injection into the suprachoroidal space (located between the sclera and choroid) avoids some of the risks of intravitreal delivery into the vitreous chamber including vitreous hemorrhage, retinal detachment and the proliferation of visual "floaters"--while still enabling access to posterior segment ocular tissue.

Fresh off a $20 million Series C financing, the company announced strong results from its Phase II clinical trial of its proprietary form of triamcinolone acetonide (CLS-TA) to treat macular edema associated with noninfectious uveitis.

Uveitis causes about 10% of the incidence of blindness in the U.S. and affects about 350,000 Americans.

In the 8-week, 22-patient trial, administration of CLS-TA "resulted in a statistically significant mean change from baseline in central subfield thickness at eight weeks after one single treatment, which was the primary endpoint," according to a company release.

The secondary endpoint, mean increase from baseline in best-corrected visual acuity, was also met. Clearside said there were no treatment-related serious adverse events. The company plans to release the full data set at an upcoming medical meeting.

"The data from this clinical trial continue to provide support for the approach to treatment of certain blinding eye diseases through SCS administration and the potential for an effective and safe option for the treatment of uveitis using CLS-TA, Clearside's proprietary triamcinolone acetonide formulation," Clearside CEO Daniel White said in a statement.

The company said it has enrolled patients in a separate Phase III trial for the treatment of patients with macular edema associated with noninfectious uveitis, completed enrollment in a Phase II trial of the formulation for use in conjunction with an injected VEGF inhibitor to treat macular edema associated with retinal vein occlusion and initiated studies to obtain an Investigational New Drug approval for the treatment of age-related macular degeneration.

- here's the release