Print 13 November 2017
DME is the most common cause of vision loss in people with diabetes mellitus. A consequence of diabetic retinopathy, DME is swelling of the retina caused by leaking blood vessels. DME affects up to 30% of people who have had diabetes for 20 years or more, and if untreated, approximately 20 to 30% of people who have it will experience moderate visual loss.
The HULK trial findings presented by Dr. Wykoff at AAO 2017 showed a visual benefit for patients receiving CLS-TA, with a greater benefit in treatment naïve eyes. Anatomic improvement was observed in all treated eyes, with more than two-thirds of those eyes achieving a greater than 50% reduction in excess central retinal thickness based on monthly measurements through 6 months after initial treatment. In the treatment naïve group, 40% of patients did not require retreatment over the entire 6 months, with an additional 20% requiring only one retreatment. Suprachoroidal CLS-TA, including in patients who received as many as five injections, was well tolerated, with a low incidence of ocular side effects, including IOP elevations.
Dr. Wykoff commented, “While the current standard of care most commonly used to treat patients with DME is use of intravitreal anti-VEGF agents, there is still a significant unmet need in this large patient population. These initial results from the HULK study suggest encouraging efficacy with a trend toward durability, particularly in the combination treatment arm.”
“We believe that eye complications associated with diabetes are caused by multiple pathways,” commented Dr.
Suprachoroidal CLS-TA, used either alone or together with an intravitreal anti-VEGF agent, is being studied as part of Clearside’s pipeline for the treatments of unmet or underserved blinding eye diseases where the pathologies manifest in the choroid and retina.
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
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.
17 November 2017
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16 November 2017