Needham points to additional data highlighting Clearside’s suprachoroidal CLS-TA potential in DME


In a new report, Needham analyst Serge Belanger writes that additional data from Clearside Biomedical’s (NASDAQ:CLSD) Phase 2 TYBEE study highlights the potential of its suprachoroidal CLS-TA used with intravitreal  Eylea  for the treatment of diabetic macular edema (DME).

He said Clearside recently updated its corporate slide deck to include additional data from the TYBEE DME trial that initially reported top-line results on May 31. As previously reported, CLS-TA plus Eylea demonstrated similar visual acuity
improvements at 24-weeks to Eylea alone, with a less intensive treatment regimen.

“The additional results demonstrate that the equivalent visual acuity gains observed at 12- and 24-weeks were attained with significantly fewer CLS-TA plus Eylea injections, compared with the Eylea alone group (36 vs.105 at 12-weeks and 82 vs.163 at 24-weeks),” Mr. Belanger said.

He maintained his “buy” rating for Clearside and $22 price target. The stock closed at $10.32 on June 21.


Mr. Belanger said that in terms of adverse events, most notably IOP increases and cataracts, TYBEE results compare favorably to prior results of CLS-TA. “These additional results further support our belief that CLS-TA can play a significant role in DME,” he added.

The initial top-line results reported on May 31 were “limited and underappreciated as it did not provide a clear picture of CLS-TA's impact on DME; non-inferior visual acuity gains to Eylea, with significantly less injections,” Mr. Belanger said.

“We believe these additional results provide much more context to CLS-TA's efficacy and safety profile and its potential role in DME,” he added.

Jennifer Poland