Clearside Biomedical Announces Fourth Quarter 2017 Financial Results and Provides Corporate Update
“Last week’s release of positive topline data from our pivotal Phase 3 PEACHTREE trial represents the achievement of a major milestone for Clearside, and a critical inflection point, providing us with the requisite clinical information to begin the process of filing an NDA and the potential opportunity to transition from a clinical-stage to a commercial-stage company,” said
Update on Key Development Programs
Suprachoroidal CLS-TA is Clearside’s proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye via the suprachoroidal space, or 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 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 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 CLS-TA (“active”) arm than in the sham (“control”) arm at each monthly evaluation. The mean improvement from baseline seen at the first evaluation timepoint 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 active 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 active arm, compared to a 19 micron mean reduction in the sham arm, a result that was also statistically significant (p < 0.001).
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 (“IOP”) adverse events were reported for approximately 11.5% of patients in the CLS-TA arm, compared to no patients in the sham group.
Detailed results from PEACHTREE will be presented at an upcoming medical conference. 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 continues to enroll patients in SAPPHIRE, a multicenter, multi-country, randomized, masked, controlled Phase 3 clinical trial designed to assess the safety and efficacy of suprachoroidal CLS-TA used in combination with intravitreally administered EYLEA® (aflibercept) (“intravitreal Eylea”) in patients with RVO. 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 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 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”)
U.S. Patent Protecting CLS-TA Used Together with an Anti-VEGF in Patients with Macular Edema
Clearside has recently received a Notice of Allowance from the U.S. Patent and
Once the administrative process is complete, the U.S. patent that issues from this application will provide intellectual property protection for a method for treating macular edema associated with eye diseases by non-surgical delivery of an anti-inflammatory drug to the SCS in combination with non-surgical administration of a VEGF modulator.
This patent represents one in a series of Clearside filings protecting the use of the SCS as a location in the eye to dose drug that provides for higher bioavailability to target retinal and choroidal diseases and substantially spares drug exposure to the anterior segment where side effects may occur in the case of drugs like corticosteroids, regardless of the method of administration. This particular allowance relates specifically to the proprietary treatment approach that Clearside is employing in its clinical development programs for suprachoroidal CLS-TA in RVO and DME.
Pipeline and Collaborations
Clearside continues nonclinical efforts, both internally and with multiple collaborators, in development areas such as gene therapy for inherited retinal disorders, wet age-related macular degeneration (“wet AMD”), and other ocular diseases that may benefit from a suprachoroidal treatment approach.
Fourth Quarter 2017 Financial Results
Clearside’s research and development expenses for the three months ended
General and administrative expenses were
Net loss for the fourth quarter of 2017 was
Full Year 2017 Financial Results
Clearside’s research and development expenses for the year ended
General and administrative expenses were
Net loss for the year ended
Cash, cash equivalents and short-term investments totaled
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 Clearside transitioning from a clinical-stage company to a commercial-stage company, the potential clinical development of Clearside’s product candidates, the availability of data from Clearside’s clinical trials, the timing of a potential filing 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
|License and collaboration revenue||$||55||$||5||$||345||$||520|
|Research and development||13,935||6,971||49,053||19,455|
|General and administrative||2,441||2,391||9,700||6,263|
|Total operating expenses||16,376||9,362||58,753||25,718|
|Loss from operations||(16,321||)||(9,357||)||(58,408||)||(25,198||)|
|Net loss per share of common stock — basic and diluted||$||(0.65||)||$||(0.45||)||$||(2.33||)||$||(1.97||)|
|Weighted average shares outstanding — basic and diluted||25,346,345||21,349,748||25,311,614||13,111,067|
|Balance Sheet Data||December 31,|
|Cash, cash equivalents and short-term investments||$||37,640||$||83,631|
|Long-term debt (including current portion)||8,009||7,586|
|Total stockholders’ equity||21,415||71,659|
Chief Financial Officer
Source: Clearside Biomedical, Inc.