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FDA approves ML6710i photodynamic laser for use with Bausch + Lomb’s PDT

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Bausch + Lomb Corporation and biomedical laser company Modulight Corporation have received FDA approval for the equivalent use of Modulight’s ML6710i photodynamic laser with Bausch + Lomb’s Visudyne (verteporfin for injection) photodynamic therapy (PDT) to treat patients with predominantly classic subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD).

Tell me more about ML6710i.

Modulight’s photodynamic laser is a transportable ophthalmic laser that includes a beam-shaping unit capable of fitting into standard slit lamps. The laser light is formed into a uniform circular spot to deliver treatment of Visudyne efficiently. It is operable via an iPad mobile application. (via)

How about Visudyne?

Visudyne is an injectable photosensitizer drug indicated for patients with—aside from subfoveal CNV due AMD—pathologic myopia or presumed ocular histoplasmosis. When used with the ML6710i, the recommended light dose is 50 J/cm2  of neovascular lesion administered at an intensity of 600 mW/cm2, with the laser light wavelength at 689±3 nm.

Beginning at 15 seconds after the start of Visudyne infusion, the light dose should be administered over the course of 83 seconds. (via)

Any adverse events reported?

Bausch + Lomb reported approximately 10% to 30% of patients reported adverse events (AEs) surrounding the injection site (pain, edema, inflammation, rashes) and visual disturbances (blurred vision, light flashes, decreased visual acuity and visual field defects). (via)

What’s the significance of this approval?

The combined delivery of ML6710i with Visudyne addresses an unmet need for patients with wet AMD with persistent fluid. Further, this modernized photodynamic laser with PDT could be an alternative or complementary therapy to existing antiangiogenic medications in the CNV treatment armamentarium.

When will ML6710i be available?

Bausch + Lomb expects it to be available in the first half of 2023.