Bausch + Lomb Named Exclusive Global Distributor of Alfa Instruments s.r.l. Intraocular Dyes

Expansion Offering Enhances and Broadens Bausch + Lomb's Surgical Portfolio with Unique and Clinically Proven Comprehensive Dye Platform

VAUGHAN, ON and CASORIA, Italy, Sept. 1, 2022 /PRNewswire/ -- Bausch + Lomb Corporation (NYSE/TSX: BLCO) ("Bausch + Lomb"), a leading global eye health company dedicated to helping people see better to live better, and Alfa Instruments s.r.l., an Italian ophthalmic medical device company, today announced that the companies have entered into an exclusive distribution agreement under which Bausch + Lomb will distribute and commercialize Alfa Instruments' line of surgical intraocular dyes, Vitreocare, globally with the exception of Italy, where Alfa Instruments is based. The agreement expands and enhances Bausch + Lomb's Surgical portfolio offering with Alfa Instruments' differentiated intraocular dyes, which have been proven safe and effective in the European Union (EU).

"The addition of these clinically proven intraocular dyes to our already comprehensive surgical portfolio will help surgeons enhance the visibility of targeted eye tissues, as well as identify transparent layers of the eye during vitreoretinal, corneal and cataract surgery,"^1-6 said Joe Gordon, president, Global Consumer, Vision Care and Surgical, Bausch + Lomb. "Our exclusive collaboration with Alfa Instruments demonstrates our commitment to providing eye care professionals with innovative products that are designed to help them achieve the best possible surgical outcomes for their patients."

Under the agreement, Bausch + Lomb will assume responsibility for all distribution and commercial activities of Vitreocare intraocular dyes, which includes:

• Vitreo Lutein for vitreous staining
• Single Lutein Blue for internal limiting membrane (ILM) staining
• Double Lutein Blue for ILM and epiretinal membrane (ERM) staining
• Phaco Lutein for anterior capsule staining
• Trypan Blue for anterior capsule staining

The unique common thread of Vitreocare intraocular dyes is lutein, a natural blue light filter. Research has shown that lutein is a safe and effective dye agent, and its antioxidant properties can further protect the retina during eye surgery.^1-6 Moreover, Single Lutein Blue and Double Lutein Blue are formulated with the new high purity (>99%) molecule Pure Benzyl-Brilliant Blue (PBB®). PBB® has been specifically designed in order to improve ILM binding affinity and to avoid diffusion into retinal layers, in order to avoid potential cytotoxicity on off-target tissues.⁷ 

"We are honored and delighted to collaborate with Bausch + Lomb, one of the best known and most respected eye care companies in the world, because it will expand access of our intraocular dyes through Bausch + Lomb's broad distribution network," said Fabio David, CEO, Alfa Instruments. "We look forward to working together to help improve the vision needs of patients undergoing vitreoretinal, cataract or corneal surgery."

Alfa Instruments' surgical dyes are currently CE marked and sold in the EU, the United Kingdom, and Switzerland. Bausch + Lomb expects to begin the distribution of the intraocular dyes in all EU countries, with the exception of Italy, during the first half of 2023. Bausch + Lomb and Alfa Instruments are also in the process of exploring regulatory requirements and approvals of the surgical dyes in other markets.

For more information on VitreoCare, visit www.vitreocare.com.

Founded in 2005 as a branch of Alfa Intes, an italian pharmaceutical company with more than sixty (60) years of experience in the pharmaceutical industry, Alfa Instruments manufactures, develops and markets specialized products for the surgical and diagnostic ophthalmic sector. The company has more than 40 years of experience in both sectors, and has grown exponentially in recent years by establishing itself as the market leader in high-tech diagnostic instruments. In 2020, with the aim of enlarging its manufacturing capabilities, the company opened a new manufacturing site in southern Italy, exclusively dedicated to the manufacturing of sterile injectables, including its full line of surgical dyes. For more information, visit www.alfaintes.it and connect with us on LinkedIn and Facebook.

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.

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. 

1. Lutein: A New Dye for Chromovitrectomy. Mauricio Maia et al. Retina, The Journal of Retinal and Vitreous Diseases, 34:262–272, 2014.
2. Phacodyne versus VisionBlue as vital dyes in Descemet membrane endothelial keratoplasty. Bucher et al. Graefes Arch Clin Exp Ophthalmol 2015 Aug;253(8):1411-2.
3. Muller cells activation and retinal damage after macular peeling: comparison between dyes. Romano et al. American Academy of Ophthalmology (AAO) 2016 - PO 270.
4. Macular peeling-induced retinal damage: clinical and histopathological evaluation after using different dyes. Romano et al. Graefe's Archive for Clinical and Experimental Ophthalmology (2018) 256:1573– 1580.
5. Use of Lutein and Zeaxanthin Alone or Combined with Brilliant Blue to Identify Intraocular Structures Intraoperatively. Sousa-Martins et al. Retina, The Journal of Retinal and Vitreous Diseases, 2012 Jul;32(7):1328-36.
6. Soluble Lutein in Combination with BrilliantBblue as a New Dye for Chromovitrectomy. Badaro et al. Graefes Arch Clin Exp Ophthalmol 2014 Jul;252(7):1071-8.
7. New Brilliant Blue G Derivative as Pharmacological Tool in Retinal Surgery. Spadaro et al. Front. Pharmacol. 2020 May; 11:708.

PBB Pure Benzyl-Brilliant Blue is a trademarks of Alfa Instruments.
All other product/brand names are trademarks of the respective owners. 
© 2022 Bausch & Lomb Incorporated or its affiliates.

SOURCE Bausch + Lomb Corporation