FDA Approves ML6710i Photodynamic Laser for Use with Photodynamic Therapy to Treat Age-Related Macular Degeneration

The FDA has approved the ML6710i (Modulight Corporation) photodynamic laser for equivalent use with verteporfin for injection (Visudyne; Bausch + Lomb Corporation) photodynamic therapy (PDT) to treat patients with predominantly classic subfoveal choroidal neovascularization, a condition caused by age-related macular degeneration (AMD).¹

“PDT continues to be an important treatment option for eye care professionals who are looking to treat patients with predominantly classic sub foveal choroidal neovascularization,” said Christina Ackermann, president, Ophthalmic Pharmaceuticals, Bausch + Lomb, in a press release. “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.”¹

AMD causes predominantly classic subfoveal choroidal neovascularization, defined as the creation of abnormal choroidal blood vessels. The more abnormal blood vessels there are, the worse the progression of AMD can be.¹

Verteporfin is an injectable photosensitizer drug that is activated by a photodynamic laser to destroy these abnormal choroidal blood vessels. ML6710i is a transportable ophthalmic laser that can be intuitively controlled by an iPad mobile application. The ML6710i’s circular shape can deliver verteporfin for injection with efficiency to patients.¹

Generally, therapy with verteporfin for injection is indicated to treat patients with classic subfoveal choroidal neovascularization due to AMD, pathologic myopia, or presumed ocular histoplasmosis.¹

The most common adverse events (AEs) with verteporfin for injection are pain, edema, inflammation, extravasation, rashes, hemorrhage, and discoloration at the injection site, and visual disturbances such as blurred vision, flashes of light, decreased visual acuity, and visual field defects. Additionally, verteporfin for injections is contraindicated in patients with porphyria—heightened sensitivity.¹

AMD, an eye disease that blurs the central vision, is caused by damage to the macula, which controls sharp, straight vision.² Although the condition does not usually lead to total blindness, it makes it difficult to do the task of daily living, such as driving, reading faces, or reading.² Experts suggest that not smoking, regular physical activity, healthy blood pressure and cholesterol, and eating healthy nutritious foods can lower the risk of developing, or worsening, AMD.²

The companies anticipate that ML6710i will be available for eye care professionals during the first half of 2023.¹

Seppo Orsila, founder and CEO of Modulight, said that their efforts with Bausch + Lomb—along with professional feedback of eye care professionals—make the company “thrilled to bring forward an innovative cloud connected laser platform that the ophthalmology community can use to deliver verteporfin for injections to patients in need of treatment of choroidal neovascularization due to AMD.”

References

1. Bausch + Lomb Corporation. Bausch + Lomb and Modulight Announce FDA Approval of ML6710i Photodynamic Laser for Use with Bausch + Lomb’s VISUDYNE® (Verteporfin for Injection). News Release. February 1, 2023. Accessed February 2, 2023. https://www.businesswire.com/news/home/20230201005394/en
2. National Eye Institute. Age-Related Macular Degeneration (AMD). Article. Last Updated June 22, 2021. Accessed on February 2, 2023. https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/age-related-macular-degeneration#:~:text=What%20is%20AMD%3F,the%20back%20of%20the%20eye).