Bausch + Lomb Named Exclusive Global Distributor of Alfa Instruments Intraocular Dyes

Bausch + Lomb and Alfa Instruments 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' intraocular dyes in the European Union (EU).

Financial terms of the deal were not disclosed. 

"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," Joe Gordon, president, global consumer, vision care and surgical, Bausch + Lomb, said in a company news release. "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.

References

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.