“Clearside is focused on treating blinding diseases by combining our innovative technology with a proprietary drug formulation to deliver pharmacotherapy to the part of the eye that requires treatment,” said
“As we look forward, our plan is to expand our expertise in macular edema associated with uveitis to broader indications, prudently build our ophthalmic pipeline, and work with potential partners to leverage our platform and provide international reach. We are looking forward to our
Key Highlights and Upcoming Milestones
- Clearside’s NDA for XIPERE for the treatment of macular edema associated with uveitis was accepted for review by the
FDAand assigned a PDUFA goal date of October 19, 2019.
- Clearside’s suprachoroidal injection platform was featured at the 42nd Annual Meeting of
The Macula Societyin multiple oral presentations, including release of new, nonclinical data on suprachoroidal administration of gene-based therapies.
- Data was presented at the American Uveitis Society’s Winter Symposium based on Clearside’s Phase 3 extension study (MAGNOLIA) demonstrating that XIPERE maintained efficacy outcomes through 48-weeks in uveitic macular edema patients.
- Clearside discontinued development of combination therapy in retinal vein occlusion based on results of its Phase 3 study (SAPPHIRE).
- Additional data from Clearside’s pivotal Phase 3 study of XIPERE (PEACHTREE) were presented at the
American Academy of Ophthalmology2018 Annual Meeting, highlighting efficacy data resolving non-infectious uveitic inflammation and clinically significant vitreous haze in patients with non-infectious uveitic macular edema.
Fourth Quarter 2018 Financial Results
Clearside’s research and development expenses for the fourth quarter of 2018 were
General and administrative expenses for the fourth quarter of 2018 were
Net loss for the fourth quarter of 2018 was
Full Year 2018 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
About Suprachoroidal Injection Platform
Clearside’s proprietary suprachoroidal injection treatment approach offers unprecedented access to the back of the eye where sight-threatening disease often occurs. The company’s unique platform is inherently flexible and intended to work with established medications, new formulations of medicines, as well as future innovations such as gene therapy.
XIPERETM (triamcinolone acetonide ophthalmic suspension) for Suprachoroidal Injection, formerly known as CLS-TA, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye via suprachoroidal injection for the treatment of macular edema associated with uveitis. Clearside’s patented technology is designed to deliver drug to the suprachoroidal space located between the choroid and the outer protective layer of the eye, known as the sclera. Suprachoroidal injection enables the rapid and adequate dispersion of medicine to the back of the eye, offering the potential for the medicine to act longer and minimize harm to the surrounding healthy parts of the eye, thus potentially providing advantageous and sustained efficacy with a favorable safety profile.
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 Clearside’s product candidates, the potential attributes and benefits of Clearside’s product candidates, and the potential approval and commercialization of XIPERE in
Investor and Media Contacts:
-Financial Tables Follow-
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||$||30||$||55||$||30||$||345|
|Research and development||17,486||13,935||68,291||49,053|
|General and administrative||4,176||2,441||14,684||9,700|
|Total operating expenses||21,662||16,376||82,975||58,753|
|Loss from operations||(21,632||)||(16,321||)||(82,945||)||(58,408||)|
|Other (expense) income, net||(6||)||(172||)||127||(567||)|
|Net loss per share of common stock — basic and diluted||$||(0.68||)||$||(0.65||)||$||(2.69||)||$||(2.33||)|
|Weighted average shares outstanding — basic and diluted||32,041,305||25,346,345||30,733,600||25,311,614|
|Balance Sheet Data||December 31,||December 31,|
|Cash, cash equivalents and short-term investments||$||40,878||$||37,640|
|Long-term debt (including current portion)||9,975||8,009|
|Total stockholders’ equity||23,620||21,415|