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

Posted on by Vaseline
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%.

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