Bausch + Lomb Launches enVista Aspire™ Intermediate Optimized Monofocal and Toric Intraocular Lenses in the European Union

Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced the commercial launch of the enVista Aspire monofocal and toric intraocular lenses (IOLs) in the European Union after receiving a CE Mark late last year. enVista Aspire combines novel Intermediate Optimized optics, which are designed for a broader depth of focus*, with the proven benefits of the enVista® platform to address vision needs in today’s modern, digital world.

“Surgeons around the world have long known the benefits of the enVista platform,” said Luc Bonnefoy, president, Surgical, Bausch + Lomb. “In the U.S., where enVista Aspire is currently available, surgeons and their patients appreciate the features of these monofocal lenses that are designed for a broader depth of focus*, and we look forward to offering that feature in Europe as part of our comprehensive IOL portfolio.”

Unlike conventional spherical monofocal IOLs and lower-order aspheric IOLs, the enVista Aspire monofocal optics allow for a range of vision beyond one focal point. Like enVista MX60E, enVista Aspire offers a glistening-free optic material and controlled, efficient unfolding through Bausch + Lomb’s proprietary StableFlex™ Technology, which aids optic recovery.

For patients with astigmatism, enVista Aspire Toric IOLs provide a proven option for treatment of their astigmatism during cataract surgery. Featuring a +0.90 cylinder design, the enVista toric IOL platform can treat less than one diopter of astigmatism at the corneal plane. The unique AccuSet haptic design enables exceptional rotational stability, an important attribute for toric lenses.

Indications and Important Safety Information for the enVista Aspire and enVista Aspire toric Hydrophobic Acrylic IOL

Indications: The enVista Aspire™ hydrophobic acrylic IOL (non-preloaded model EA) is indicated for primary implantation in the capsular bag of the eye in adult patients for the visual correction of aphakia following removal of a cataractous lens.

The enVista Aspire toric IOL is indicated for primary implantation in the capsular bag of the eye in adult patients for the visual correction of aphakia and corneal astigmatism following the removal of a cataractous lens for improved uncorrected distance vision.

Device Description: The Aspire IOL uses an optical modification of the posterior aspheric surface to create a small continuous increase in IOL power within the central 1.5 mm diameter to slightly extend the depth of focus. However, clinically meaningful extension of the depth of focus has not been demonstrated in clinical trials.

Warnings

As with any surgical procedure, there is risk involved. Physicians considering IOL implantation under any of the following circumstances should weigh the potential risk/benefit ratio: (1) Recurrent severe anterior or posterior segment inflammation or uveitis; (2) Patients in whom the IOL may affect the ability to observe, diagnose, or treat posterior segment diseases; (3) Surgical difficulties at the time of cataract extraction, which might increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure, or significant vitreous prolapse or loss); (4) A distorted eye due to previous trauma or developmental defect in which appropriate support of the IOL is not possible; (5) Circumstances that would result in damage to the endothelium during implantation; (6) Suspected microbial infection; (7) Patients in whom neither the posterior capsule nor zonules are intact enough to provide support.

Precautions

1. Neither the safety and effectiveness, nor the effects of the Aspire IOL optical design on depth of focus, contrast sensitivity, and subjective visual disturbances (glare, halo, etc.) have been evaluated clinically. MTF testing of the Aspire IOL optical design (used in model ETA) may aid the surgeon in understanding the theoretical image quality expected with the Aspire IOL compared to the enVista monofocal IOL MX60E. However, these do not fully assess all aspects of clinical difficulties under all conditions. Surgeons must weigh the potential benefits of the modified optical design of the Aspire IOL (model ETA) against the potential for risks associated with a degradation in vision quality and the lack of clinical data to characterize the impact of the Aspire IOL optical design on contrast sensitivity and subjective visual disturbance. These considerations may be especially relevant to patients with certain pre-existing ocular conditions (prior corneal refractive surgery, irregular corneal astigmatism, severe corneal dystrophy, macular disease, optic nerve atrophy, etc.) or intraoperative conditions (posterior capsular rupture, complications in which the IOL stability could be compromised, inability to place IOL in capsular bag, etc).
2. The safety and effectiveness of the IOL have not been substantiated in patients with pre-existing ocular conditions and intraoperative complications. Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the benefit/risk ratio before implanting an IOL in a patient with one or more of these conditions. Physicians considering IOL implantation in such patients should explore the use of alternative methods of aphakic correction and consider IOL implantation only if alternatives are deemed unsatisfactory in meeting the needs of the patient.
3. Patients with preoperative problems, such as corneal endothelial disease, abnormal cornea, macular degeneration, retinal degeneration, glaucoma, and chronic drug miosis may not achieve the visual acuity of patients without such problems. The physician must determine the benefits to be derived from IOL implantation when such conditions exist.

Adverse Events: As with any surgical procedure, there is risk involved. Potential complications accompanying cataract or implant surgery may include, but are not limited to the following: corneal endothelial damage, infection (endophthalmitis), retinal detachment, vitritis, cystoid macular edema, corneal edema, pupillary block, cyclitic membrane, iris prolapse, hypopyon transient or persistent glaucoma, and secondary surgical intervention. Secondary surgical interventions include but are not limited to: lens repositioning, lens replacement, vitreous aspiration or iridectomy for pupillary block, wound leak repair, and retinal detachment repair.

ATTENTION: This is not all you need to know. Please refer to the Directions For Use labeling for a complete listing of indications, full risk and safety information, clinical study information, etc.

*Based on optical bench testing. MTF study in IS02 model cornea, comparison of MX60E and enVista Aspire.

About Bausch + Lomb

Bausch + Lomb is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from birth through every phase of life. Its comprehensive portfolio of approximately 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 approximately 13,000 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 X, LinkedIn, Facebook and Instagram.

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