|Targacept Completes Recruitment in Phase 2b TC-5619; Abbott Announces FDA Approval of the TECNIS Toric Intraocular Lens|
|By Staff and Wire Reports|
|Thursday, 18 April 2013 19:32|
Targacept (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, announced it has completed recruitment of patients in the Phase 2b study of TC-5619 as a treatment for negative symptoms and cognitive dysfunction in schizophrenia. The company expects to report top-line results from the study by the end of 2013. TC-5619 is a highly selective modulator of the alpha7 neuronal nicotinic receptor.
“I would like to thank the patients, study sites and investigators who have helped us reach this important milestone in the development of TC-5619 as a potential new treatment for schizophrenia,” said Dr. Stephen A. Hill, Targacept's President and Chief Executive Officer. “Current schizophrenia therapies primarily impact positive symptoms of schizophrenia, leaving the negative symptoms and cognitive dysfunction largely untreated. A new and effective treatment that addresses this medical need would be critically important for the millions of schizophrenia patients unable to function in society.”
The ongoing Phase 2b study is a double blind, placebo controlled, randomized, parallel group trial being conducted at sites in Eastern Europe and the United States. The primary outcome measure is the Scale for the Assessment of Negative Symptoms (SANS). Key secondary outcome measures include the CogState Schizophrenia Battery (composite score), a computerized test battery, and the University of California, San Diego Performance-Based Skills Assessment, Brief Version. The study is designed to randomize 456 patients with stable schizophrenia who are taking a fixed dose of an atypical antipsychotic. The study includes a 4-week screening period, followed by a 24-week treatment period during which patients receive one of two doses of TC-5619 (5mg or 50mg) or placebo once daily.
Abbott (NYSE: ABT) announced that the TECNIS Toric 1-Piece intraocular lens (IOL) has received U.S. FDA approval and is launching in the United States for the treatment of cataract patients with pre-existing corneal astigmatism.
Corneal astigmatism is a condition where the curvature of the cornea is uneven, preventing light rays from focusing clearly on the retina, resulting in blurred vision. Intraocular lenses are implanted in a patient's eye after the removal of the natural lens that has become clouded by a cataract. Unlike conventional IOLs, the TECNIS Toric 1-Piece IOL can correct a patient's loss of focus due to pre-existing corneal astigmatism of one diopter (a unit of measurement of the refractive power of a lens) or greater.
The average age for the cataract surgery patient in the United States is approximately 68 years with more than 3.5 million procedures performed annually. As the U.S. population continues to age, the number of cataract surgeries is expected to grow nearly 3 percent each year, increasing patient demand for improved, precise visual outcomes and independence from glasses.
"The TECNIS Toric 1-Piece IOL represents the latest advancement in cataract technology and expands Abbott's portfolio of the TECNIS family of IOLs," said Murthy Simhambhatla, senior vice president, Medical Optics, Abbott. "The TECNIS Toric 1-Piece IOL allows surgeons to offer an additional lens option that provides proven visual outcomes to increase patient satisfaction."
Along with delivering precise visual outcomes for patients, rotational stability is an important attribute of a toric IOL. The TECNIS Toric 1-piece IOL remains very stable once inserted into the eye, and meets the new standard for toric IOL rotational stability, as approved by the American National Standards Institute (ANSI).
In addition to providing astigmatism correction, the TECNIS Toric 1-Piece lens minimizes imprecise light focusing (spherical aberration) to provide sharper distance vision for the patient.
"The TECNIS Toric IOL decreases astigmatism while improving visual quality, with improved functional vision," said Kevin Waltz, O.D., M.D., Eye Surgeons of Indiana, and clinical investigator for the TECNIS Toric IOL. "Having implanted several TECNIS Toric IOLs within clinical trials, I find it delivers excellent patient results."
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Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, today announced that it has completed recruitment of patients in the Phase 2b study of TC-5619 as a treatment for negative symptoms and cognitive dysfunction in schizophrenia.
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