According to a news release from Bausch + Lomb and biomedical laser company Modulight, the FDA has approved the ML6710i photodynamic laser for equivalent use with Visudyne.
Bausch + Lomb Corp. and biomedical laser firm Modulight Oyj announced Wednesday the US Food and Drug Administration has approved their ML6710i photodynamic laser for use with the eye-health company's photodynamic therapy, Visudyne.
Visudyne (verteporfin for injection) photodynamic therapy (PDT) is for the treatment of patients with predominantly classic subfoveal choroidal neovascularisation, or the creation of abnormal choroidal blood vessels, due to age-related macular degeneration (AMD). ML6710i is expected to be available for eye care professionals during the first half of 2023.
In a news release, Christina Ackermann, president, Ophthalmic Pharmaceuticals, Bausch + Lomb, pointed out that PDT continues to be an important treatment option for eye care professionals who are looking to treat patients with predominantly classic subfoveal choroidal neovascularisation.
“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,” she said in the release.
According to the companies, ML6710i is a transportable ophthalmic laser that is controlled from an iPad mobile application. The laser’s beam shaping unit, which can be fit into all common slit lamps used for eye examinations, is formed into a circular, uniform spot to 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 neovascularisation due to AMD,” Seppo Orsila, founder and CEO, Modulight, said in the release.
Visudyne is an injectable photosensitizer drug that is indicated for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to AMD, pathologic myopia or presumed ocular histoplasmosis. It 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.