Clearside BioMedical Inc. (NASDAQ: CLSD) saw its shares make an incredible gain to start the week after the firm announced positive topline results from its late-stage trial. Specifically, the firm provided results from its pivotal Phase 3 clinical trial of suprachoroidal CLS-TA in patients with macular edema associated with noninfectious uveitis.
For some quick background: uveitis is a set of inflammatory conditions affecting the eye. It is also one the world’s leading causes of blindness.
In the trial, 47% of patients who received suprachoroidal CLS-TA every 12 weeks gained at least 15 letters in best corrected visual acuity (BCVA), as measured using the Early Treatment of Diabetic Retinopathy Study scale, compared to 16% of patients who underwent a sham procedure.
This improvement, which was the primary endpoint of the trial, was statistically significant. In terms of improvements in BCVA, the mean change from baseline was better in the treatment arm than the sham arm at each monthly evaluation. The average improvement from baseline was maintained throughout the evaluation period, with 9.6 letters gained at week 4 and 13.7 letters at week 24 in the active arm, compared to 1.2 letters at week 4 and 2.9 letters at week 24 in the control arm, respectively.
The treatment was generally well tolerated, with no treatment-related serious adverse events reported in the trial.
Rahul N. Khurana, MD, an investigator for PEACHTREE, Partner at Northern California Retina Vitreous Associates, and Clinical Associate Professor in Ophthalmology at UCSF Medical Center, commented:
The PEACHTREE study was the first pivotal phase 3 clinical trial of a drug candidate for patients with uveitic macular edema in which a BCVA measure was the primary efficacy endpoint, potentially raising the bar for future trials in this population. Typically, uveitic macular edema may persist despite adequate control of uveitis itself, and it is challenging to treat and may persist despite multiple interventions. Also, while corticosteroids are the most common treatment for all complications of uveitis, including the associated macular edema, systematic controlled studies of this kind are rare. I believe that based on these positive results, and if marketing authorization is obtained from the FDA, suprachoroidal CLS-TA has the potential to become a new paradigm for the treatment of visual impairment associated with macular edema associated with non-infectious uveitis.
Shares of Clearside were last seen up about 43% at $11.14 on Monday, with a consensus analyst price target of $19.20 and a 52-week range of $5.30 to $13.25.