Bausch + Lomb and Modulight Announce FDA Approval of Photodynamic Laser for Use with VISUDYNE®
Bausch + Lomb and Modulight Corporation, a biomedical laser company, today announced that the FDA has approved the ML6710i photodynamic laser for equivalent use with Bausch + Lomb’s VISUDYNE® (verteporfin for injection) photodynamic therapy (PDT) for the treatment of patients with predominantly classic subfoveal choroidal neovascularization, or the creation of abnormal choroidal blood vessels, due to Age-related Macular Degeneration (AMD).1
ML6710i is expected to be available for eye care professionals during the first half of 2023.
“PDT continues to be an important treatment option for eye care professionals who are looking to treat patients with predominantly classic subfoveal choroidal neovascularization,” said Christina Ackermann, president, Ophthalmic Pharmaceuticals, Bausch + Lomb. “With the approval of ML6710i, eye care professionals now have a new state-of-the-art photodynamic laser that addresses a significant unmet need in PDT and is specifically designed to deliver VISUDYNE to patients who suffer from wet AMD with persistent fluid.”
The ML6710i is a cutting-edge, user-friendly, and portable ophthalmic laser that can be easily operated from an iPad mobile application., the laser's beam shaping unit, which can be fitted into all standard slit lamps used for eye exams, forms a circular, uniform spot enable efficient treatment delivery of VISUDYNE®.
“As a result of our efforts with Bausch + Lomb, along with the feedback that many eye care professionals provided to our teams, we are thrilled to bring forward an innovative cloud connected laser platform that the ophthalmology community can use to deliver VISUDYNE to patients in need of treatment of choroidal neovascularization due to AMD,” said Seppo Orsila, founder and CEO, Modulight.
About VISUDYNE
VISUDYNE is an injectable photosensitizer, which is used for those who have AMD, pathological myopia, or suspected ocular histoplasmosis and who have primarily classic subfoveal choroidal neovascularization. VISUDYNE is activated through use of a photodynamic laser via direct laser excitation, delivering a targeted approach that specifically destroys abnormal choroidal blood vessels to help prevent further disease progression and help patients maintain their vision.¹
Reference:
1. VISUDYNE [package insert], Bausch & Lomb Incorporated
