Janney starts Clearside Biomedical at buy; PT $24

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Janney Montgomery Scott initiated coverage of Clearside Biomedical (NASDAQ:CLSD) with a “buy” rating and fair value estimate of $24. The stock closed a $10.21 on June 27.

Clearside’s microinjector device targets drug delivery to the back of the eye through administration into the suprachoroidal space (SCS) versus current standard of care of intravitreal injections. 

“SCS microinjection has potential for fewer adverse events, quicker onset of action, improved drug bioavailability at the retina and choroid, reduced concentration of drug, and longer duration of effect resulting in overall fewer treatments, compared with current therapies,” writes analyst Esther Hong. 

“With upcoming milestones (Phase 3 data in retinal vein occlusion, NDA submission and review in uveitis), a promising approach to therapy, and transformation into a commercial-stage company, we believe the next 12-to-18 months present inflection points for Clearside,” she added.

Ms. Hong said ophthalmologists she has spoken with look forward to adding another tool to their armamentarium and “we believe the ease of use of the device coupled with the well-known efficacy of triamcinolone for the treatment of macular edema (ME) with a more favorable safety profile supports use of SCS CLS-TA as standard of care in macular edema associated with non-infectious uveitis (ME/NIU) and first-line therapy in combination with anti-VEGF agents in retinal vein occlusion (ME/RVO).”

If approved, she said SCS CLS-TA would be the first treatment for ME/NIU. Positive Phase 3 data demonstrated statistical significance in improvement in visual acuity and reduction in retinal thickness. 

The current standard of care is off-label use of intravitreal corticosteroids that have intraocular pressure (IOP) elevation rates of more than 25%. SCS CLS-TA demonstrated an impressively low 11.5% rate of IOP elevations, she added. 

In ME/RVO, Ms. Hong said Phase 2 data demonstrated SCS CLS-TA plus Eylea reduced additional Eylea injections by 60% over three months, improved visual acuity, and sustained reduction in retinal thickness, compared with Eylea therapy alone.

She added, "We believe [Clearside's] technology has provided a way to combine two well-known therapies (anti-VEGF agents and corticosteroids) to potentially provide superior efficacy in vision improvement, lower IOP and cataract risk, and reduce the burden of monthly intravitreal injections resulting in improved patient compliance.  We believe this new combination therapy has the potential to become standard of care."

Clearside's Phase 3 program in ME/RVO will evaluate reduction in additional anti-VEGF injections and earlier improvement in visual acuity versus monotherapy. 

In DME, she said Phase 2 data of quarterly CLS-TA in combination with Eylea, compared with monthly Eylea injections over a six-month period, demonstrated similar improvement in vision and reduction in retinal thickness.  However, combination therapy reduced the frequency of Eylea injections. 

“Combination therapy potentially reduces the frequency of Eylea injections from eight per year to four, significantly impacting patient burden and improving compliance,” she added.

Melane LaBelle Sampson