Clearside Releases Phase II RVO Results
Dosing of the suprachoroidal space with Zuprata, Clearside Biomedical’s proprietary triamcinolone formulation, can provide high bioavailability of drug to the retina and choroid while avoiding the anterior segment and minimizing the potential for side effects associated with steroid treatments like elevated intraocular pressure (IOP) and cataracts, Clearside president and CEO Daniel White said during the Posterior Segment Company Showcase at OIS@AAO 2016.
In the treatment of retinal vein occlusion, Zuprata improved vision at earlier time points and the improvements were maintained for at least three months, reducing the need for additional intravitreal injections of anti-VEGF, White said.
As he explained, the suprachoroidal injection platform gives Clearside “exclusive and proprietary access via a microinjector to 17 cm2 of the human eye through the suprachoroidal space.”
White previewed Phase II results of Zuprata for naïve retinal vein occlusion (RVO) that were later reported at the American Academy of Ophthalmology Retina Subspecialty Day. The trial compared 46 patients divided equally between two arms: intravitreal Eylea (aflibercept, Regeneron) alone and Zuprata plus Eylea. At month three, 16 in the Eylea-only arm required additional treatments versuss five in the combined arm; and the Eylea-only arm showed a 11.3-letter improvement in visual acuity versus an 18.9-letter gain in the combination group.
There were no serious adverse events in the study. More than 5% of the Zuprata patients had conjunctival hyperemia, eye pain, ocular hypertension, and increased IOP, White said. Clearside plans to initiate the Phase III trial of Zuprata in RVO in the first half of 2017.
White also reviewed key outcomes from the previously reported Dogwood trial of Zuprata for treatment of macular edema associated with non-infectious uveitis. This involved a single suprachoroidal injection of Zuprata 4 mg and 0.8 mg in 22 subjects. At two months, 69% of subjects showed a 20% or greater reduction in central retinal thickness and 56% had retinal thickness of 310 microns or less. Complete Phase III data are due in the second half of 2017, White stated.
White also described three other Clearside programs: Axitinib for wet age-related macular degeneration (AMD), with a pre-IND meeting expected by year-end; and two preclinical programs with a proprietary compound for retinal vascular disease and a gene therapy orphan indication.
Mr. White is the President and Chief Executive Officer of Clearside Biomedical, Inc. From 2008 to 2011, Mr. White served as Executive Director, Global Corporate Development, for Stiefel Laboratories, Inc., a dermatology pharmaceutical company acquired by GlaxoSmithKline in 2009.