Print 10 May 2017
“The Clearside team continues our pursuit of transformative, elegant, precise solutions to restore and preserve vision,” said
Update on Key Development Programs
CLS-TA for suprachoroidal administration (“suprachoroidal CLS-TA”), Clearside’s proprietary suspension formulation of the corticosteroid triamcinolone acetonide, used either alone or together with an intravitreal anti-VEGF agent, is part of Clearside’s pipeline for the treatments of unmet or underserved blinding eye diseases where the pathologies manifest in the choroid and retina.
Macular Edema Associated with Non-Infectious Uveitis
In the first quarter of 2017, Clearside continued to enroll patients in PEACHTREE, the Phase 3 trial of suprachoroidal CLS-TA in patients with macular edema associated with non-infectious uveitis. Clearside currently anticipates that it will report initial results from PEACHTREE in early 2018.
Macular Edema Associated with Retinal Vein Occlusion (“RVO”)
SAPPHIRE is a multicenter, multi-country, randomized, masked, controlled trial designed to assess the safety and efficacy of suprachoroidal CLS-TA used with intravitreal Eylea in subjects with RVO. The primary objective of this trial will be to determine the proportion of patients in each arm with best corrected visual acuity improvement of at least 15 letters from baseline at eight weeks after initial treatment. Several secondary efficacy and safety outcomes will also be evaluated.
Diabetic Macular Edema (“DME”)
HULK is an open-label, multi-center Phase 1/2 study designed to assess the safety and efficacy of the administration of a suprachoroidal injection of CLS-TA along with an intravitreal injection of Eylea in patients with DME naïve to treatment, as well as that of a suprachoroidal injection of CLS-TA alone in patients with DME who have previously been treated with intravitreal anti-VEGF or intravitreal corticosteroid treatment and still require further treatment. Clearside currently expects to report preliminary results from HULK in the second half of 2017.
Clearside is also planning a multicenter, randomized, masked, controlled Phase 2 trial, TYBEE, to evaluate suprachoroidal CLS-TA along with intravitreal Eylea, compared to intravitreal Eylea only, in patients with DME, over a 6-month evaluation period. The primary endpoint of the trial will be the change in best corrected visual acuity from baseline in the combination treatment arm compared to the intravitreal Eylea only arm. Clearside currently expects to enroll the first patient in TYBEE in mid-2017.
Wet Age-Related Macular Degeneration (“Wet AMD”)
Clearside continues to explore potential opportunities for the use of pharmacological therapies via suprachoroidal injection for the treatment of wet AMD.
As Clearside’s development programs move further into the clinic, opportunities have been created to collaborate with third-party proprietary programs. In this regard, Clearside continues preclinical efforts with multiple collaborations in gene therapy, complement inhibition, and alternative mechanisms in the treatment of complex retinal diseases like AMD.
First Quarter 2017 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 2017 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 clinical development of, and the potential market for, Clearside’s product candidates and the availability of data from Clearside’s clinical trials. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside’s reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Clearside’s Annual Report on Form 10-K for the year ended
CLEARSIDE BIOMEDICAL, INC.
Selected Financial Data
(in thousands, except share and per share data)
|Statements of Operations Data||Three Months Ended
|Research and development||7,590||4,589|
|General and administrative||2,671||1,273|
|Total operating expenses||10,261||5,862|
|Loss from operations||(10,256||)||(5,357||)|
|Other expense, net||(117||)||(92||)|
|Net loss per share of common stock — basic and diluted||$||(0.41||)||$||(2.05||)|
|Weighted average shares outstanding — basic and diluted||25,250,333||2,660,370|
|Balance Sheet Data||March 31,||December 31,|
|Cash, cash equivalents and short-term investments||$||77,451||$||83,631|
|Long-term debt (including current portion)||7,691||7,586|
|Total stockholders’ equity||67,163||71,659||
Russian pharmaceutical company NovaMedica, a portfolio company of RUSNANO, announces the start of construction of a plant for the production of sterile injectable drugs as part of its long-term strategy to localize innovative medicines and technologies of their development and production in Russia. The plant will be built in the industrial park “Vorsino” in the Kaluga region.
23 March 2018
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