Clearside Biomedical (NASDAQ:CLSD) has initiated a strategic realignment of its R&D, moving resources from its preclinical program of axitinib for the treatment of wet AMD and towards its more advanced ongoing clinical development program for the treatment of diabetic macular edema (DME) with Zuprata, its proprietary suspension formulation of the corticosteroid, triamcinolone acetonide.
Recent trial results from other industry participants that are pursuing combination therapy agents for wet AMD have led Clearside to reconsider the viability of further development of its proprietary suspension formulation of axitinib.
“Clearside is fortunate to have built a well-diversified pipeline targeting the restoration and preservation of vision,” Daniel White, president and CEO, said in a statement.
He pointed out that corticosteroids historically 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, he added.
In November 2016, Clearside announced the enrollment of the first patient in a Phase 1/2 clinical trial, known as HULK, assessing the administration of Zuprata, either alone or together with EYLEA for the treatment of DME.
Suprachoroidally injected Zuprata for the treatment of DME is part of Clearside’s pipeline of drug treatments for unmet or underserved blinding eye diseases where the pathologies manifest in the choroid or retina.