Bausch + Lomb and Modulight Announce FDA Approval of ML6710i Photodynamic Laser for Use with Bausch + Lomb’s VISUDYNE® (Verteporfin for Injection)

Rhea-AI Summary

Bausch + Lomb Corporation (NYSE/TSX: BLCO) and Modulight Corporation announced FDA approval for the ML6710i photodynamic laser. This laser is approved for use with Bausch + Lomb's VISUDYNE® therapy, targeting predominantly classic subfoveal choroidal neovascularization caused by Age-related Macular Degeneration (AMD). The ML6710i, designed for easy use and transport, will be available in the first half of 2023. This innovation addresses a significant unmet need in photodynamic therapy, allowing eye care professionals to treat patients more effectively.

Positive

• FDA approval of ML6710i laser enhances Bausch + Lomb's product offerings.
• Introduction of a modern and transportable laser meets a significant market demand.
• Potential for increased revenue through enhanced treatment options for AMD.

Negative

• Specific approval conditions may limit usage of VISUDYNE in certain patient groups.

VAUGHAN, Ontario & TAMPERE, Finland--(BUSINESS WIRE)-- Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb”), a leading global eye health company dedicated to helping people see better to live better, and Modulight Corporation (“Modulight”), a biomedical laser company, today announced that the U.S. Food and Drug Administration (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.”

ML6710i is a modern, easy-to-use and transportable ophthalmic laser that is controlled intuitively 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 neovascularization due to AMD,” said Seppo Orsila, founder and CEO, Modulight.

About VISUDYNE

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. 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

INDICATION

VISUDYNE (verteporfin for injection) therapy is indicated for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia or presumed ocular histoplasmosis.

IMPORTANT SAFETY INFORMATION

• VISUDYNE (verteporfin for injection) is contraindicated for patients with porphyria or known hypersensitivity to any component of this preparation.
• Standard precautions should be taken during infusion of VISUDYNE to avoid extravasation, including but not limited to:
  • A free-flowing intravenous (IV) line should be established before starting VISUDYNE infusion and the line should be carefully monitored.
  • Due to the possibly fragility of vein walls of some elderly patients, it is strongly recommended that the largest arm vein possible, preferably the antecubital, be used for injection.
  • Small veins in the back of the hand should be avoided.
• Extravasation of VISUDYNE, especially if the affected area is exposed to light, can cause severe pain, inflammation, swelling or discoloration at the injection site. If extravasation does occur, the infusion should be stopped immediately. The extravasation area must be thoroughly protected from direct light until swelling and discoloration have faded in order to prevent the occurrence of local burn, which could be severe. Cold compresses should be applied to the injection site. Oral medication for pain relief may be administered.
• Following injection with VISUDYNE, care should be taken to avoid exposure of skin or eyes to direct sunlight or bright indoor light for 5 days. If emergency surgery is necessary within 48 hours after treatment, as much of the internal tissue as possible should be protected from intense light.
• Patients who experience severe decrease of vision of 4 lines or more within 1 week after treatment should not be retreated, at least until their vision completely recovers to pretreatment levels and potential benefits and risks of subsequent treatment are carefully considered by the treating physician.
• The most frequently reported adverse events (occurring in approximately 10%-30% of patients) were injection site reactions (including pain, edema, inflammation, extravasation, rashes, hemorrhage, and discoloration), and visual disturbances (including blurred vision, flashes of light, decreased visual acuity, and visual field defects, including scotoma).

Click here for full Prescribing Information.

About Modulight

Modulight Corporation is a biomedical laser company that designs and manufactures products for oncology, ophthalmology and genetics. The company also provides solutions for selected high value-add applications including quantum computing and digital press. The company’s products include medical devices, subsystems, software, cloud services and specialized semiconductors. Modulight’s products are used worldwide by many Fortune 500 companies, pharmaceutical companies, and well-known cancer centers and universities. Modulight was founded in 2000 and is headquartered in Tampere, Finland. Its U.S. headquarters is in Palo Alto, CA. For more information, visit www.modulight.com or follow Modulight on Twitter, LinkedIn, Facebook, YouTube and Instagram.

About Bausch + Lomb

Bausch + Lomb is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Its comprehensive portfolio of more than 400 products includes contact lenses, lens care products, eye care products, ophthalmic pharmaceuticals, over-the-counter products and ophthalmic surgical devices and instruments. Founded in 1853, Bausch + Lomb has a significant global research and development, manufacturing and commercial footprint with more than 12,000 employees and a presence in nearly 100 countries. Bausch + Lomb is headquartered in Vaughan, Ontario with corporate offices in Bridgewater, New Jersey. For more information, visit www.bausch.com and connect with us on Twitter, LinkedIn, Facebook and Instagram.

Forward-looking Statements

This news release may contain forward-looking statements, which may generally be identified by the use of the words “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “estimates,” “potential,” “target,” or “continue” and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in Bausch + Lomb’s filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. They also include, but are not limited to, risks and uncertainties caused by or relating to the evolving COVID-19 pandemic, and the fear of that pandemic and its potential effects, the severity, duration and future impact of which are highly uncertain and cannot be predicted, and which may have a material adverse impact on Bausch + Lomb, including but not limited to its project development timelines, launches and costs (which may increase). Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch + Lomb undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.

References

1. VISUDYNE [package insert], Bausch & Lomb Incorporated.

VISUDYNE is a registered trademark of Cheplapharm Arzneimittel GmbH used under license.
Any other product/brand names and/or logos are trademarks of the respective owners.
© 2023 Bausch & Lomb Incorporated or its affiliates.
VID.0006.USA.23

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Bausch + Lomb Investor Contacts:

Arthur Shannon/Allison Ryan

arthur.shannon@bausch.com

allison.ryan@bausch.com

(877) 354-3705 (toll free); (908) 927-0735



Bausch + Lomb Media Contacts:

Lainie Keller/Kristy Marks

lainie.keller@bausch.com

kristy.marks@bausch.com

(908) 927-1198; (908) 927-0683



Modulight Investor Contacts:

Ulla Haapanen

ulla.haapanen@modulight.com

(408) 218-7960



Modulight Media Contacts:

Zoe Ylöniemi

zoe.yloniemi@modulight.com

(408) 239-3488

 

Source: Bausch + Lomb Corporation

FAQ

What is the significance of the FDA approval of the ML6710i laser for Bausch + Lomb?

The approval allows the ML6710i laser to be used with VISUDYNE® for treating AMD, expanding treatment options for eye care professionals.

When will the ML6710i laser be available for use?

The ML6710i is expected to be available for eye care professionals in the first half of 2023.

What is the function of the VISUDYNE® therapy?

VISUDYNE® is used to treat AMD by targeting and destroying abnormal blood vessels to help maintain vision.

How does the ML6710i laser improve treatment for AMD?

The ML6710i is designed for effective delivery of VISUDYNE® and addresses unmet needs in photodynamic therapy.

What are the key features of the ML6710i photodynamic laser?

It is user-friendly, transportable, and can be intuitively controlled via an iPad application.