Laidlaw starts Clearside Biomedical at buy; PT $18
Laidlaw launched coverage of Clearside Biomedical (NASDAQ:CLSD) with a “buy” rating and $18 price target. The stock closed at $10.28 on July 13.
Clearside’s proprietary microinjector enables drug delivery to the back of the eye through the suprachoroidal space (SCS) to more directly administer drugs to the retina and choroid.
“Following results in the Phase 3 PEACHTREE trial, we view Clearside’s proprietary microinjector through the SCS as relatively de-risked,” writes analyst Francois Brisebois.
The company’s lead product candidate is CLS-TA for macular edema due to non-infectious uveitis. The PEACHTREE study met its primary endpoint as 47% of patients treated with CLS-TA gained more than or equal to 15 letters in best-corrected visual acuity, compared with 16% in the sham procedure arm. Mean reduction from baseline was an impressive 157 microns in central subfield thickness vs. 19 microns in the sham arm, she said.
“These highly statistically significant primary and secondary endpoints de-risk the SCS injection platform, in our view, and we expect an NDA filing in the fourth quarter of 2018, followed by a U.S. launch in the first quarter of 2020,” she added.
Clearside’s second value driver is CLS-TA for macular edema due to retinal vein occlusion. Ms. Brisebois said the Phase 2 TANZANITE trial “showed potential for a reduced treatment burden as 60% fewer additional Eylea treatments were needed in the treatment arm (CLS-TA plus Eylea) versus Eylea alone.”
Visual acuity also improved, with statistical significance at month two, “a positive indication for their two Phase 3 trials expected to readout by the fourth quarter of 2018 and second half of 2019, respectively,” she added.
In addition, she said Clearside is also targeting diabetic macular edema, for which it recently hit all endpoints in a Phase 2 trial.
“With a relatively de-risked proprietary technology and a quickly progressing pipeline, we see Clearside as undervalued,” according to Ms. Brisebois.