LumiThera has conducted the FDA review for the Valeda treatment of the Sehkraft treatment in AMD

SEATTLE, November 5, 2024–(BUSINESS WIRE)–LumiThera Inc., a medical device company that manages photobiomodulatory (PBM) for augmented injuries and ailments, will engage in sales to the U.S. Food & Drug Administration (FDA) Valeda^® Light Delivery System with the treatment of patients with modified macular degeneration (AMD) treatment, one of the main offices for the pleasure of the nervous system in people out of 55 in industrialized countries.

The Valeda therapy is the FDA’s first for treatment in patients with AMD. Valeda has spread out a sale of the best Sehschärfe (BCVA) in 24 months of >5 books or a sail on the Sehtafel. In the separate American LIGHTSITE-III study, the Valeda treatment was initiated in the first place and an examination of the Steigerung and the right is one of the results.

LumiThera presented the clinical data of LIGHTSITE III in the USA as technical packages to the FDA to develop new antrags with special contact rollers.

“The new development of the treatment is based on the patient’s care with the patient’s health and safety and the development of healthy lifestyles, the Valeda Light Delivery System and the development of the Valeda Light Delivery System,” said Lori Holder, Vice President, Regulatory Affairs, LumiThera , Inc.

“The RCT-Ergetische clinical study in patients with her intermediate doctor AMD has been followed for a period of 24 months and a positive health profile,” explains Dr. David Boyer of the Retina Vitreous Associates Medical Group in Beverly Hills, California. “Patients If no invasive treatment has been performed, the treatment in the insanity exploration may be expanded with an option for patients and etwas, in the area of the patient and the patient.”

“The primary end point of the study during the improvement of the results”, erklärte Dr. Glenn Jaffe from Duke Reading Center. We follow up with more anatomical endpoints from BL during the combined 24-month study, during the course of the study, and with PBM for the maintenance of the net anatomy. The PBM treatment has a positive influence on more anatomical biomarkers. They have investigated the PBM that affects and causes the atrophy, thus reducing the atrophy in the PBM treatment. , 6.8% average 24%.

“There have been more years in which patients in the American Valeda have a photobiomodulation treatment with more Wellenlanges, which their Verfügung zu set. A non-invasive treatment option for patients with AMD drug has emerged, which improves the results of the treatment and the disease further explained before any of the most successful treatments are possible,” says Dr. Clark Tedford, president and CEO. “Treat zur Besserung der Sehkraft bei trockener AMD no longer offers American patients an important option.”

Uber AMD

AMD is one of the main issues for the enjoyment of time in people over 65 years of age. Der Verlust des zentralen Sehvermögens kann es erschweren, Face zu acknowledge, Fahrzeuge zu führen or Arbeiten im Nahbereich zu fluent, wie z. B. Kochen or repairs in Haushalt. The cooling of the AMD continues with the alternative estimates at 7 level, from 4.2% for the 45 to 49 years to 27.2% for the 80 to 85 years. Estimates will increase the Prävalenz-zwischen 2020 (195.6 Millionen) and 2030 (243.3 Millionen) by 20%.

Uber LumiThera

LumiThera, Inc. is a part of ophthalmic medical products, with the power of light^™ (Kraft des Lichts) nutzt, one of the most used Ansatz zur Rekennung, Behandlung und Überwachung van Netzhauterkrankungen, insbesondere der trockenen AMD, anzubiten.

LumiThera is with its Vorzeigeproduct, dem Valeda^® Light Delivery System, developed in the innovation of ophthalmic photobiomodulation (PBM). The Valeda-Behandlung with more well-being is thought for Patients with treatment of AMD. The Food and Drug Administration (FDA) has developed the Valeda treatment market for Trockene AMD patients for the medical care treatment. Valeda is a member of the EU CE Kennzeichnet and in the American states of Late America.

AdaptDx Pro^® It is a long Dunkeladaptometer, which is used by KI, a solitary patient fahrung of beets. Improved dunkel adaptation is the newest biomarker for trockenic AMD and can take years before clinical symptoms manifest. AdaptDx Pro is available in the US and Canada.

The NOVA Vison Testing System is a fully electrical physiological platform that enables objective assessment of signaling pathways for visual and neurovisual signals. VEP is available in the US and US states. ERG is no longer available in the US.

More information about Valeda can be found at www.lumithera.com. AdaptDx Pro and NOVA come from LumiThera Diagnostics, Inc. bzw. Diopsys, Inc. erhaltlich.

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Original version on businesswire.com as follows: https://www.businesswire.com/news/home/20241104873993/de/

Contacts

Allison Dabney
[email protected]
Senior Director of Marketing

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