sábado, 26 de diciembre de 2009

Avedro comienza los ensayos clínicos de Keraflex® KXL para tratar el queratocono

Avedro comienza los ensayos clínicos de Keraflex® KXL para tratar el queratocono
Los resultados preliminares muestran un aplanamiento notable de la córnea con gran mejoría visual

WALTHAM, Massachusetts.--(BUSINESS WIRE)--Durante el 5o Congreso Internacional de Entrecruzamiento Corneal para el Queratocono llevado a cabo en Leipzig, Alemania, el 5 de diciembre, Avedro presentó resultados clínicos preliminares muy prometedores para el tratamiento del queratocono, una enfermedad progresiva de la córnea. El procedimiento, conocido como Keraflex® KXL, se realiza sin incisiones con el fin de corregir la córnea sin extirpar ningún tejido.

El queratocono, o QC, es una deformación de la cornea en forma de cono, que generalmente se manifiesta en la adolescencia o alrededor de los 20 años de edad, padecida por millones de personas en todo el mundo, afectando gravemente su visión. El QC es un trastorno progresivo que puede requerir transplante de córnea en algunos pacientes.

Los resultados preliminares del primer grupo de pacientes tratados con Keraflex KXL, a cargo del Prof. Ömer Faruk Yilmaz, médico del Hospital de Investigación y Capacitación Oftalmológica de Beyoglu en Estanbul, Turquía, fueron presentados en Leipzig por el Prof. John Marshall, PhD, FRCPath, FRCOphthal (Hon), profesor emérito de oftalmología del King’s College de Londres; y el Dr. Peter Hersh, profesor de oftalmología de la UMDNJ – Facultad de Medicina de Nueva Jersey y director del Instituto Oftalmológico de la Córnea y Terapia Láser – CLEI Centro para el Queratocono en Nueva Jersey.

En sus presentaciones, los doctores Marshall y Hersh informaron un aplanamiento notable y mayor regularidad y homogeneidad en la superficie de la córnea en todos los sujetos con queratocono.

El Dr. Hersh señaló: "Keraflex KXL es una nueva tecnología prometedora para disminuir la deformidad cónica del queratocono, y regularizar la superficie de la cornea. Nuestra experiencia preliminar demuestra mejorías en la córnea queratocónica que no hemos visto con tratamientos anteriores. Esto debería mejorar la visión en paciente con queratocono, un problema de la cornea que resulta difícil de corregir, así como mejorar la visión con lentes de contacto y con anteojos. Esperamos que Keraflex pueda contribuir a evitar los transplantes de córnea en muchos pacientes que, de otro modo, no tendrían otra alternativa”.

El Dr. Marshall agregó: “Me entusiasma muchísimo la tecnología de Avedro. Tiene consecuencias importantísimas para el tratamiento del queratocono, dado que no solamente puede aplanar la córnea, sino que tiene el potencial de corregir los errores refractivos asociados sin ningún debilitamiento biomecánico y algo que realmente no esperábamos: fortalece la córnea y debería prevenir o demorar la distorsión”.

En sus comentarios sobre las presentaciones, el doctor David Muller, presidente y director ejecutivo de Avedro, señaló: "Es obvio que los asistentes vieron estos datos con buenos ojos, y se entusiasmaron con esta tecnología prometedora para sus pacientes con queratocono, quienes en la actualidad tienen pocas opciones de tratamiento. Si bien se ha estado estudiando Keraflex KXL para la corrección de la miopía desde principios de año, los datos presentados en Leipzig pertenecen a un estudio independiente sobre queratocono que comenzó en noviembre. El efecto debilitante sobre la visión que ejerce el queratocono y la falta de alternativas para corregir la refracción, han llevado a la compañía a redoblar sus esfuerzos para introducir rápidamente Keraflex KXL en el mercado para tratar pacientes con queratocono en Europa, apenas obtengan la aprobación CE Mark"

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