Clearside enrols first patient in TOPAZ trial for RVO; SAPPHIRE data expected in Q4

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Clearside Biomedical (NASDAQ:CLSD) has enrolled the first patient in a Phase 3 clinical trial, known as TOPAZ, of suprachoroidal CLS-TA used with an intravitreally administered anti-VEGF agent for the treatment of macular edema associated with retinal vein occlusion (RVO).

Suprachoroidal CLS-TA is Clearside’s proprietary suspension of the corticosteroid, triamcinolone acetonide, formulated for administration to the back of the eye via the suprachoroidal space, which is the space located between the choroid and the outer protective layer of the eye known as the sclera.

“TOPAZ is our second Phase 3 trial of suprachoroidal CLS-TA with an intravitreal anti-VEGF agent in patients with RVO,” Daniel White, president and CEO, said in a statement.

Clearside’s first Phase 3 RVO study, called SAPPHIRE, is evaluating suprachoroidal CLS-TA in combination with intravitreal, Eylea. If the primary endpoints are met in both the TOPAZ and SAPPHIRE trials, “we expect to seek an agnostic label in the U.S., where suprachoroidal CLS-TA can be used together with any anti-VEGF agent for the treatment of RVO,” he added.

Clearside also said that, based on patient enrollment progress, it now expects to report preliminary data from the SAPPHIRE trial in the fourth quarter of 2018 instead of the first quarter of 2019.

J.P. Morgan analyst Anupam Rama reiterated his “overweight” rating for Clearside and said 2018 is shaping up to be a catalyst rich year. “We continue to view Clearside shares as undervalued, given its profile as an emerging commercial-stage company in the ophthalmology space.”

Clearside said TOPAZ is a randomized, masked, controlled trial to assess the safety and efficacy of suprachoroidal CLS-TA used together with one of two intravitreal anti-VEGF agents, Lucentis or Avastin, in treatment naïve patients with RVO. Clearside anticipates total enrollment of about 460 patients in the trial.

Patients in the combination arm of the trial will receive suprachoroidal CLS-TA, together with an intravitreal anti-VEGF agent, at the beginning of the trial, an intravitreal anti-VEGF agent alone at week 4, and suprachoroidal CLS-TA together with an intravitreal anti-VEGF agent at weeks 12 and 24.

Patients in the control arm will receive an intravitreal anti-VEGF agent alone at the beginning of the trial and every four weeks thereafter through week 24. After 24 weeks, patients in both arms will be followed for an additional six months.

The primary objective of the trial will be to determine the proportion of patients in each arm with a best-corrected visual acuity improvement of at least 15 letters from baseline at eight weeks after initial treatment. Several secondary efficacy and safety endpoints will also be evaluated

Suprachoroidal CLS-TA, used either alone or together with an intravitreal anti-VEGF agent, is being studied as part of Clearside’s pipeline of treatments for unmet or underserved blinding eye diseases where the pathologies manifest in the retina and the choroid.