Category: Clinical

Month: 18 Jan 2016

Issue: not yet available

Phase II clinical trial results for micro-injection of triamcinolone in treatment of macular edema (following non-infectious uveitis) reaches primary endpoint

Results from a Phase II study to evaluate the safety and efficacy of a micro- injectable formulation of triamcinolone for the treatment of macular edema (associated with non-infectious uveitis) has reported a statistically significant mean change from baseline in central subfield thickness at eight weeks following a single administration of the drug (p=0.0018). The sponsior of the study, Clearside Biomedical, additionally reported statistical significance in the secondary endpoint, a mean increase from baseline in best-corrected visual acuity (p=0.0004). No treatment-related serious adverse events were reported in the trial and the company has committed to publish the full data set at an upcoming meeting.

 

The clinical Phase II trial has been registered as a randomized, masked, multicenter study to assess the safety and efficacy of two different doses of a triamcinolone formulation in the treatment of subjects with macular edema following non-infectious uveitis. Each subject received a single suprachoroidal micro-injection of either 4.0 mg or 0.8 mg triamcinolone in a total volume of 100 μL. The sponsor is understood to have plans to seek approval of their formulation and administration route under section 505(b)(2) of the Food, Drug and Cosmetic Act. This route permits applicants to use previously collected safety and efficacy data from either the scientific literature or from previously approved relevant products to support their request for authorisation.

 

Clearside Biomedical is a private ophthalmic device and pharmaceutical company based in Alpharetta, Georgia, USA. Established in January 2012, Clearside’s proprietary micro-injection platform allows compartmentalization of an API within a specific area of the eye. The proprietary platform was developed from an academic collaboration between the Georgia Institute of Technology and Emory University School of Medicine. The technology was developed from the work of Mark Prausnitz, Ph.D., Regents’ Professor and Love Family Professor of Chemical & Biomolecular Engineering at the Georgia Institute, and Henry Edelhauser, Ph.D., Professor in the Department of Ophthalmology at Emory University School of Medicine. The targeted delivery approach is focused on the use of a micro-needle to deliver agents to the supra-choroidal space (SCS) between the choroid and the sclera in order to more efficiently reach tissues impacted by chorioretinal disease. In a separate announcement, following the release of clinical trial results, Clearside stated that it had filed papers with the US SEC in relation to a proposed initial public offering of shares on the NASDAQ Global Market.

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