“Coming on the heels of the recent release of positive topline results from our pivotal Phase 3 PEACHTREE trial in uveitis, and as we have continued to accumulate additional data from the trial around the resolution of signs and symptoms, our confidence in the potential of suprachoroidal CLS-TA to become a powerful new treatment option for this sight-threatening disease, both at home and abroad, continues to build,” said
Update on Key Development Programs
Suprachoroidal CLS-TA is Clearside’s proprietary suspension formulation of the corticosteroid triamcinolone acetonide for administration to the back of the eye via the suprachoroidal space (“SCS™”), which is the space located between the choroid and the outer protective layer of the eye known as the sclera. 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.
Macular Edema Associated with Non-Infectious Uveitis
In the PEACHTREE trial, 47% of patients in the treatment arm 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 (“ETDRS”) scale, from baseline at week 24, compared to 16% of patients in the control arm who underwent a sham procedure. This improvement, which was the primary endpoint of the trial, was statistically significant (p < 0.001). Further, in terms of improvements in BCVA, the mean change from baseline was better in the treatment arm than in the control arm at each monthly evaluation. The mean improvement from baseline seen at the first evaluation at week 4 was maintained throughout the trial, with 9.6 letters gained at week 4 and 13.7 letters at week 24 in the treatment arm, compared to 1.2 letters at week 4 and 2.9 letters at week 24 in the control arm. For the other key secondary endpoint, administration of suprachoroidal CLS-TA resulted in a mean reduction from baseline of 157 microns in central subfield thickness at week 24 in the treatment arm, compared to a 19 micron mean reduction in the control arm, a result that was also statistically significant (p < 0.001).
In addition, based on further analysis performed subsequent to the
Resolution of Signs of Uveitis
|Subjects Displaying Reduction
to Zero at Week 24
|CLS-TA Treatment Arm (%)||Control Arm
|Anterior Chamber Cells||72.0||17.0|
|Anterior Chamber Flare||74.3||22.0|
With respect to durability of effect, over 85% of the patients in the treatment arm did not receive rescue therapy, remaining on suprachoroidal CLS-TA over the 24 weeks of the trial, compared to between 30% and 35% of patients in the control arm who did not receive rescue therapy.
Suprachoroidal CLS-TA was generally well tolerated, with no treatment-related serious adverse events reported in the trial. Through 24 weeks, corticosteroid-related elevated intraocular pressure, or IOP, adverse events were reported for approximately 11.5% of patients in the treatment arm, compared to no patients in the control arm. Both the treatment and control arms reported similar cataract adverse events, with approximately 8.3% of patients in the treatment arm and 7.8% of patients in the control arm developing cataracts. No patients underwent surgeries associated with these adverse events.
Clearside expects to submit a new drug application (“NDA”) for suprachoroidal CLS-TA to treat macular edema associated with non-infectious uveitis to the
Macular Edema Associated with Retinal Vein Occlusion (“RVO”)
Clearside expects to complete patient enrollment in SAPPHIRE, its first Phase 3 clinical trial of suprachoroidal CLS-TA used in combination with the intravitreal anti-VEGF agent, EYLEA® (aflibercept) (“intravitreal Eylea”) in treatment naïve patients with RVO, in the second quarter of 2018. SAPPHIRE is a randomized, masked, multi-center, controlled trial with evaluations every 4 weeks. After 24 weeks, patients will be followed for approximately an additional six months. The primary objective of this trial is to determine the proportion of patients in the combination treatment arm, compared to the intravitreal Eylea alone control arm, with BCVA improvement of at least 15 ETDRS letters from baseline at eight weeks after initial treatment. Several secondary efficacy and safety endpoints will also be evaluated. Based on patient enrollment progress, Clearside expects to report preliminary 8-week data from the SAPPHIRE trial in the fourth quarter of 2018.
If the primary endpoints are met in both the TOPAZ and SAPPHIRE trials, Clearside intends to seek a class label in
Diabetic Macular Edema (“DME”)
Pipeline and Collaborations
Clearside continues nonclinical efforts, both internally and with multiple collaborators, in development areas such as gene therapy, wet age-related macular degeneration (“wet AMD”), and other ocular diseases that may benefit from a suprachoroidal treatment approach.
First Quarter 2018 Financial Results
Clearside’s research and development expenses for the three months ended
General and administrative expenses were
Cash, cash equivalents and short-term investments totaled
Net loss for the first quarter of 2018 was
Conference Call & Webcast Details
Clearside is pleased to invite all interested parties to participate in a conference call today at
Cautionary Note Regarding Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Clearside’s current beliefs and expectations. These forward-looking statements include expectations regarding the potential clinical development of Clearside’s product candidates, the availability of data from Clearside’s clinical trials, the timing of a potential submission of an NDA with the
|CLEARSIDE BIOMEDICAL, INC.|
|Selected Financial Data|
|(in thousands, except share and per share data)|
|Statements of Operations Data||Three Months Ended
|Research and development||13,379||7,590|
|General and administrative||3,074||2,671|
|Total operating expenses||16,453||10,261|
|Loss from operations||(16,453||)||(10,256||)|
|Other expense, net||(154||)||(117||)|
|Net loss per share of common stock — basic and diluted||$||(0.62||)||$||(0.41||)|
|Weighted average shares outstanding — basic and diluted||26,818,137||25,250,333|
|Balance Sheet Data||March 31,||December 31,|
|Cash, cash equivalents and short-term investments||$||101,055||$||37,640|
|Long-term debt (including current portion)||7,307||8,009|
|Total stockholders’ equity||85,931||21,415|