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6/18/2018, Monday

Media Contact:
Kristy Marks
kristy.marks@bausch.com 
908-927-0683

Teresa Panas
tpanas@biocommnetwork.com 
973-809-8590


BAUSCH + LOMB RECEIVES FDA PRE-MARKET APPROVAL FOR ENVISTA® TORIC MX60T INTRAOCULAR LENS


New Hydrophobic Acrylic Toric IOL Offers Predictable Astigmatism
Correction, Exceptional Rotational Stability


BRIDGEWATER, N.J., June 18, 2018 – Bausch + Lomb, a leading global eye health company, today announced that it has received Pre-Market Approval (PMA) from the U.S. Food and Drug Administration (FDA) for the enVista® toric MX60T, the company’s first hydrophobic acrylic intraocular lens (IOL) for astigmatism correction.

The enVista® toric MX60T IOL features a one-piece aberration-free, aspheric optic with fenestrated, step-vaulted, modified C-loop haptic design that delivers exceptional rotational stability and ensures predictable astigmatism correction.1 Additionally, the optic’s posterior square edge provides a 360 degree barrier to posterior capsular opacification (PCO).2,3,4 

The enVista® IOL material remains the only single-piece, hydrophobic acrylic material domestically available that have been proven to be glistening-free.1 The enVista® material also has the potential for increased resistance to scratches and abrasions that may occur during loading and surgical manipulation.5,6

“Building on the proven features and benefits of the enVista® family of IOLs, MX60T represents another innovation in the continued expansion of this lens platform,” said Chuck Hess, vice president and general manager, U.S. Surgical, Bausch + Lomb.  “The addition of this new lens to our portfolio offers surgeons a wide range of IOLs with seven cylinder powers to meet their astigmatic patients’ needs.”

In a recent prospective, multicenter study designed to evaluate the safety and effectiveness of the enVista® toric MX60T, the lens demonstrated 5° or less of absolute rotation in 100% of subjects.1

“The rotational stability of a toric IOL is critical, as even the slightest rotation can lead to a decrease in the toric effect, compromising outcomes,” said Mark Packer, medical monitor for the enVista® toric MX60T study and ophthalmologist, Boulder, CO.  “The results of this study show that the enVista® toric MX60T lens provides excellent rotational stability, astigmatism correction and uncorrected visual acuity.1 I look forward to this lens being available to astigmatic cataract patients who would benefit from this technology based on the wonderful results I observed during the clinical study.” 

About Bausch + Lomb
Bausch + Lomb, a Valeant Pharmaceuticals International, Inc. company, is a leading global eye health organization that is solely focused on protecting, enhancing, and restoring people’s eyesight. Our core businesses include ophthalmic pharmaceuticals, contact lenses, lens care products, ophthalmic surgical devices and instruments. We develop, manufacture and market one of the most comprehensive product portfolios in our industry with products available in more than 100 countries. 


References

  1. Bausch + Lomb. enVista® Toric IOL DFU. 
  2. Nishi O et al. J Cataract Refract Surg. 2004;30:2170-2176.
  3. Nixon DR et al. J Cataract Refract Surg. 2010;36:929-934. 
  4. Buehl, Wolf and Findl, Oliver. “Effect of Intraocular Lens Design on Posterior Capsule Opacification.” J Cataract Refractive Surgery, 2008; 34: 1976-1985. 
  5. Elachchabi, Amin; Martin, Paul; Goldberg, Eugene; and Mentak, Khalid. “Nanoindentation Studies on Hydrophobic Acrylic IOLs to Evaluate Surface Mechanical Properties.” ESCRS presentation, 2007; 1-12. 
  6. Data on file. Bausch & Lomb Incorporated, 2016. 

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