The Alpharetta, Ga.-based company reported research and development costs of approximately $17.5 million with a total net loss of $21.6 million, or 68¢ per share, for the three months ended December 31, seeing R&D costs grow 25.5% while losses grew 31.2% when compared with the same period during the previous year.
Losses per share were behind the 57¢ loss-per-share consensus on Wall Street.
For the full year, Clearside Biomedical reported research and development costs of approximately $68.3 million, with a total net loss of $82.8 million, or $2.69 per share, seeing R&D costs increase 39.2% while losses increased 40.4% over the previous year.
Losses per share grew 15.5% compared to the company’s 2017 fiscal year.
“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. The recent acceptance of our new drug application for Xipere for Suprachoroidal Injection for the treatment of macular edema associated with uveitis marks a significant milestone for Clearside and our unique, therapeutic platform. We believe this targeted drug delivery approach has broad applicability utilizing proven compounds, like triamcinolone, novel small molecules, and gene therapy. 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 October 19, 2019 PDUFA goal date to receive a response from the U.S. Food and Drug Administration. Our team is working diligently on launch preparations to make Xipere available to uveitis patients with macular edema, the most common cause of uveitis-related blindness and where there is no approved therapy. Given the timing of our October 19th PDUFA date, if approved, we expect to formally launch XIPERE in the first quarter of 2020,” prez & CEO Daniel White said in a press release.
Shares in Clearside Biomedical fell 2.1% today, closing at $1.37.
Last December, Clearside Biomedical said that it submitted a new drug application to the FDA for Xipere – a suprachoroidal injection designed for the treatment of macular edema associated with uveitis.
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