Clearside Biomedical Announces First Patient Randomized in Phase 2 Clinical Trial of CLS-TA Used Together with Eylea in Patients with Diabetic Macular Edema
11 July 2017
TYBEE is a multicenter, randomized, masked, controlled phase 2 clinical trial designed to evaluate the safety and efficacy of suprachoroidal CLS-TA along with intravitreal Eylea, compared to intravitreal Eylea monotherapy, in patients with DME who are naïve to pharmacologic treatment. In this trial, patients with DME will be randomized into either a combination arm of patients receiving suprachoroidal CLS-TA together with intravitreal Eylea or a control arm of patients receiving only intravitreal Eylea. The primary outcome measure will be a comparison between the two study arms of change from baseline in best corrected visual acuity at 3 months.
“We believe that eye complications associated with diabetes are caused by multiple pathways in this difficult to treat disease, and that we can improve the visual outcomes for newly diagnosed DME patients by administering suprachoroidal CLS-TA together with an intravitreal anti-VEGF inhibitor like Eylea,” said
CLS-TA for suprachoroidal administration, used either alone or together with an intravitreal anti-VEGF agent, is part of Clearside’s pipeline for the treatments of unmet or underserved blinding eye diseases where the pathologies manifest in the choroid and retina.
Cautionary Note Regarding Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Clearside’s current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of Clearside’s product candidates and the timing of preliminary data from Clearside’s TYBEE trial. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside’s reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Clearside’s Annual Report on Form 10-K for the year ended