Clearside Biomedical (NSDQ:CLSD) said today it will redirect its R&D efforts from its pre-clinical axitinib wet age-related macular degeneration therapy to its Zuprata diabetic macular edema treatment.
The Alpharetta, Ga.-based company said that recent trial results from other companies investigating combination therapies for wet AMD have led Clearside to reconsider its proprietary suspension formulation of axitinib. The company selected axitinib in mid-2016 for the treatment of wet AMD through suprachoroidal administration.
Clearside said it plans to continue investigating axitinib and other compounds for the treatment of wet AMD, but it will not submit an Investigational New Drug application to the FDA, according to regulatory filings.
“Clearside is fortunate to have built a well-diversified pipeline targeting the restoration and preservation of vision,” president & CEO Daniel White said in prepared remarks. “Historically, corticosteroids have shown promise in the treatment of DME, but the results have been confounded by side effects like cataracts and elevated intraocular pressure. We believe that the encouraging results that we have observed in our RVO and Uveitis programs suggest that suprachoroidally injected Zuprata may exhibit similar benefits in treating DME. Clearside will, however, continue to explore potential opportunities for the use of suprachoroidal delivery in the wet AMD space.”
In mid-February, Clearside enrolled the 1st patient in a phase III trial evaluating Zuprata, its suspension formulation of triamcinolone acetonide, in combination with Eylea, intravitreal aflibercept, for the treatment of macular edema associated with retinal vein occlusion.
The trial is slated to enroll 460 patients with retinal vein occulsion to assess the efficacy and safety of the combination therapy. In 1 arm of the study, patients will receive the combination therapy at the beginning of the trial, intravitreal Eylea at week 4 and the combination therapy again at weeks 12 and 24. Patients in the control arm will receive intravitreal Eylea alone every 4 weeks until week 24, the company reported.
Researchers will follow up with the patients for 6 months after 24 weeks of treatment, according to Clearside. The trial’s primary objective is to determine the proportion of patients in each group with the best corrected visual acuity improvement of at 8 weeks following initial treatment.