Clearside Biomedical (NSDQ:CLSD) has enrolled the first patient in a Phase III trial evaluating its eye drug combined with an intravitreally-administered anti-VEGF agent as a treatment for macular edema associated with retinal vein occlusion.
The company’s drug, CLS-TA, is a proprietary suspension of triamcinolone acetonide designed to be administered in the space located between the choroid and the sclera.
Clearside’s Ph3 Topaz trial will evaluate the drug’s safety and efficacy when given with one of two intravitreal anti-VEGF agents: Roche’s Lucentis or Genentech’s Avastin. The late-stage trial is slated to enroll 460 patients, according to Clearside.
Patients in the combo-therapy arm of the trial will receive suprachoroidal CLS-TA with an intravitreal anti-VEGF compound at the start of the trial, just an intravitreal anti-VEGF drug at week 4 and then both drugs at weeks 12 and 24. In the control arm, patients will be given an intravitreal anti-VEGF agent at the beginning of the trial and every four weeks until week 24.
After 24 weeks have passed, researchers plan to monitor the patients’ progress for six more months. The study’s primary endpoint is the proportion of patients in each arm with a best corrected visual acuity improvement of at least 15 letters from baseline to eight weeks.
“Topaz is our second Phase III trial of suprachoroidal CLS-TA with an intravitreal anti-VEGF agent in patients with RVO,” president & CEO Daniel White said in prepared remarks.
“Our first Phase III RVO study, called Sapphire, is evaluating suprachoroidal CLS-TA in combination with intravitreal Eylea. Accordingly, if the primary endpoints are met in both the Topaz and Sapphire trials, we expect to seek an agnostic label in the United States, where suprachoroidal CLS-TA can be used together with any anti-VEGF agent for the treatment of RVO,” White added.
The company plans to report preliminary data from its Sapphire trial in the fourth quarter of 2018 – a few months earlier than previously reported.