Clearside Eyes Major Milestones in 2018-19
Clearside Biomedical has a full agenda of major near-term milestones in the development of its suprachoroidal CLS-TA (triamcinolone-acetonide) platform in 2018 and 2019, president and CEO Daniel White said at the OIS@AAO 2017 Public Device and Biopharma Company Showcase. The milestones are in three different indications: for macular edema associated with uveitis, topline Phase III data from the PEACHTREE trial is expected early in 2018, with a new drug application filing expected later in the year; for macular edema associated with retinal vein occlusion – an indication for which CLS-TA would be used with intravitreal Eylea (aflibercept, Regeneron) – a readout of the Phase III SAPPHIRE trial is expected for Q1 2019; and for diabetic macular edema (DME), which involves CLS-TA with or without Eylea, topline Phase II data from the TYBEE trial is expected in Q2 2018. White also previewed Phase I/II data from the HULK trial in DME, which was later reported more fully at the American Academy of Ophthalmology Retina Subspecialty Day, that showed 4 of 10 patients in the treatment-naive arm required no additional treatment after the initial dosing, and three required the first additional treatment at three months.