Bausch + Lomb Launches EyeGility™ Inserter Preloaded IOL Delivery System in the United States

Bausch + Lomb Launches EyeGility™ Inserter Preloaded IOL Delivery System in the United States

• EyeGility is designed for the enVista® family of IOLs
• Offers balanced push force for smooth delivery, convenient one-handed operation
• Available now for enVista Aspire™; will be available for enVista Envy™ in the coming months

VAUGHAN, Ontario--(BUSINESS WIRE)--Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced the U.S. launch of the EyeGility™ Inserter preloaded IOL delivery system.

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"The enVista IOL platform has long been appreciated by surgeons for its glistening-free optic and differentiated optic portfolio to suit a wide range of patients," said Wayne Caulder, vice president and general manager, North America Surgical, Bausch + Lomb. "The launch of EyeGility enables surgeons to continue delivering these benefits to their patients while also gaining the efficiencies and advantages offered by this preloaded IOL delivery system."

Designed specifically for preloaded enVista Aspire IOLs and Envy IOLs, the EyeGility inserter offers convenient one-handed operation and balanced push force for smooth delivery, with a silicone soft-tipped plunger that supports reliable IOL delivery with injection through a 2.4mm incision. The inserter provides improved comfort compared to previous Bausch + Lomb inserters, and the loading process allows for up to 20 minutes of standby time from prep to lens delivery.¹

"I frequently choose enVista IOLs for my patients, and in my hands, the EyeGility inserter has consistently provided a smooth, comfortable IOL delivery," said Parag Parekh, MD, Clearview Eye Consultants, Reynoldsville, Pa.

The EyeGility Inserter is now available in the U.S. as part of the enVista Aspire preloaded IOLs. enVista Envy lenses preloaded into EyeGility inserters will be available in the coming months.

EyeGility Inserter preloaded IOL delivery system Indications and Important Safety Information

INDICATIONS: The EyeGility inserter for enVista preloaded is indicated for folding and inserting of enVista IOL models approved for use with this IOL insertion device as indicated in the IOL approved labeling.

PRECAUTIONS AND WARNINGS: Use with other enVista IOL models is likely to cause damage to the IOL and/or inserter and may result in eye damage. Store at room temperature. Do not freeze. Avoid high temperatures (>43° C/109°F). Do not use if the packaging is exposed to environmental conditions outside of those specified. Keep dry. Keep away from sunlight. Folding and compression of the lens should be done just prior to insertion and delivery. Failure to follow the instructions for use may result in patient injury. Prior to opening, inspect the blister tray for signs of damage that may affect integrity of device sterility. If damaged, do not use. If the insertion system fails to properly deliver the lens, use a new IOL and a new inserter.

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

ATTENTION: Reference the Directions for Use labeling for a complete listing of directions for use, indications and important safety information.

enVista Aspire hydrophobic acrylic IOL Indications and Important Safety Information

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.

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.

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

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.

enVista Envy toric and non-toric IOL Indications and Important Safety Information

Indications
The enVista Envy hydrophobic acrylic IOL is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia with less than or equal to 1.0 D preoperative corneal astigmatism following removal of a cataractous lens to mitigate the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity to an aspheric monofocal IOL.

The enVista Envy toric hydrophobic acrylic IOL is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia and corneal astigmatism following removal of a cataractous lens to mitigate the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity to an aspheric monofocal IOL.

Warnings/PrecautionsPhysicians should weigh the potential risk/benefit ratio before implanting the enVista Envy lens under any of the circumstances or conditions outlined in the Instructions for Use labeling. Some visual disturbances may be expected due to the superposition of focused and unfocused multiple images. These may include some perceptions of halos or radial lines around point sources of light (starbursts) under nighttime conditions, glare, double vision, haziness and blurred vision. It is expected that, in a small percentage of patients, the observation of such phenomena will be annoying and may be perceived as a hindrance, particularly in low illumination conditions such as nighttime driving. As with other trifocal IOLs, there is a possibility that visual disturbances may be significant enough that the patient will request explant of the IOL. A reduction in contrast sensitivity as compared to a monofocal IOL may be experienced by some patients, therefore, patients implanted with trifocal IOLs should exercise caution when driving at night or in low light or poor visibility conditions. Care should be taken to achieve IOL centration as IOL decentration may result in patients experiencing visual disturbances or suboptimal vision under certain lighting conditions. The surgeon must target emmetropia to achieve optimal visual performance. Patients should be advised that unexpected outcomes could lead to continued spectacle dependence or the need for secondary surgical intervention (e.g., intraocular lens replacement or repositioning). Please provide a copy of the Patient Information Brochure, which can be found at https://www.bausch.com/IFU. Posterior capsule opacification (PCO) may significantly affect the vision of patients with multifocal IOLs earlier in its progression than patients with monofocal IOLs. This may be due to the reduced contrast sensitivity observed with multifocal IOLs.

Additional Precautions for Toric IOLs: The enVista Envy Toric IOL has not been evaluated in a clinical study. In general, astigmatism that is corrected with a higher cylinder power IOL can result in clinically significant residual astigmatism. The effect of residual astigmatism at distance, intermediate, and near was evaluated in a clinical study of patients who had been implanted with non-toric enVista Envy IOLs and were induced with cylinder power to simulate various levels of residual astigmatism. If a secondary surgical intervention is necessary to reposition the IOL, explantation should be considered as some patients may have recurrent or persistent issues related to rotational instability and misalignment.

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

ATTENTION: See the Directions for Use for a complete listing of indications and important safety information.

About Bausch + Lomb
Our mission is simple - we help people see better to live better, all over the world. For nearly two centuries we've evolved with the changing needs of patients and customers, and our commitment to innovation and improving the standard of care in eye health has never been stronger. From contact lenses to prescription products, over-the-counter options, surgical devices and more, we're turning bold ideas into better outcomes through passion, perseverance and purpose. Learn more at www.bausch.com and connect with us on Facebook, Instagram, LinkedIn, X and YouTube.

Forward-looking Statements
This news release may contain forward-looking information and statements within the meaning of applicable securities laws (collectively, "forward-looking statements"). Forward-looking statements may generally be identified by the use of the words "anticipates," "seeks," "expects," "plans," "should," "could," "would," "may," "will," "believes," "potential," "pending" or "proposed" 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. 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. data on file

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Source: Bausch + Lomb Corporation