Bausch + Lomb Announces Publication of TENEO™ Excimer Laser Clinical Trial Results in Journal of Refractive Surgery

VAUGHAN, Ontario, August 12, 2024 – Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced the publication of TENEO Excimer Laser clinical trial results in the August issue of the Journal of Refractive Surgery. The study supported the January U.S. Food and Drug Administration (FDA) approval of TENEO for myopia and myopic astigmatism LASIK vision correction surgery*.

“Results from this pivotal study, combined with the experience of surgeons in more than 50 countries around the world where TENEO is available, demonstrate the platform’s safety and efficacy and its potential to become a transformative tool for refractive surgeons in the U.S.,” said Anthony Wallace, vice president and general manager, North America, Bausch + Lomb Surgical.

The prospective, multicenter study, designed to evaluate the safety and efficacy of TENEO, included 168 subjects who underwent LASIK surgery performed using the platform. Surgeons taking part in the study made no nomogram adjustments, as the TENEO software treated based off the manifest refraction using an aspheric ablation algorithm. Investigators followed enrolled subjects for nine months, assessing post-operative visual and refractive outcomes. Study participants also completed the Patient-Reported Outcomes with LASIK (PROWL) questionnaire before and after surgery.

Key findings from the trial:1

  • Nine months after surgery, 97.8% and 100% of eyes achieved uncorrected distance visual acuity and corrected distance visual acuity of 20/25 or better.
  • The mean manifest refraction spherical equivalent improved from -5.67±2.52 D preoperatively to -0.04±0.32 D postoperatively, with 92.7% of eyes reaching residual refractive error within ±0.50 D.
  • Investigators observed residual refractive cylinder ± 0.50 and ± 1.00 D in 93% and 99.4% of eyes respectively.
  • Refractive outcomes remained stable throughout the nine-month follow-up period.
  • The percentage of patients satisfied with their vision increased from 27.7% preoperatively to 98.1% after surgery, according to the results of the PROWL questionnaire.

“These results clearly demonstrate that the TENEO platform is a safe and effective option for the correction of myopia and myopic astigmatism*, delivering outstanding, consistent visual and refractive outcomes,” said lead author George Waring IV, MD, Waring Vision Institute, Mt. Pleasant, South Carolina. “Having performed the first TENEO commercial cases in the United States shortly after it received FDA approval, I can confirm that my experience in clinic thus far mirrors what we experienced in the study.”

About TENEO
The first excimer laser approved in the U.S. in nearly two decades, TENEO offers several unique features not offered by previous excimer laser platforms. The advanced eye-tracker operates at 1,740Hz – more than three times the speed of the laser’s repetition – helping to ensure that a patient’s eye movement does not negatively impact the laser ablation pattern. The platform’s high-speed laser operates at 500Hz – the fastest ablation time of all excimer lasers available in the U.S. – at approximately 1.2 second per diopter**.

The user-friendly graphical user interface touchscreen simplifies set up and allows surgeons to access the patient data they choose without flipping through screens. The cutting edge TENEO software treats the manifest refraction and does not require a nomogram adjustment, therefore streamlining surgical planning by eliminating several steps prior to treatment.

The compact design of the TENEO makes it the smallest excimer laser unit available in the U.S. The platform also includes features to address both surgeon and patient comfort, such as a 360° swiveling microscope that adapts to surgeon height and posture and a treatment bed that accommodates patients of all sizes, swings out for easier access, and can be customized for optimal head positioning. The bed can also swivel to be positioned for a second treatment device ensuring enhanced patient comfort and safe movement and simplifying the process.

Indications and Important Safety Information for Technolas Teneo 317 Model 2 System

Indications for Use. The Technolas Teneo 317 Model 2 is indicated for laser-assisted in situ keratomileusis (LASIK) in: (1) Patients for the reduction or elimination of myopic astigmatism up to -10.00 D MRSE, with sphere between -1.00 D to -10.00 D and cylinder between 0.00 and -3.00 D; (2) Patients who are 22 years of age or older; (3) Patients must have a stable refraction in the last 12 months, as documented by previous clinical recordings, i.e., the spherical and cylindrical portions of the manifest distance refraction have not progressed at a rate of more than 0.50 D per year prior to the baseline examination in the eye(s) to be treated.

WARNING. Danger of injury due to failure to observe the patient selection criteria! Failure to observe the contraindications and potential adverse effects may result in serious permanent patient injury. The usage of the laser system is limited to a specific field of applications. Observe the contraindications and potential adverse effects listed in the User Manual before selecting a patient and starting any treatment.

Contraindications. Contraindications of the Technolas Teneo 317 Model 2 include patients: (1) with any type of active connective tissue disease or autoimmune disease; (2) with signs of keratoconus, abnormal corneal topography, and degenerations of the structure of the cornea (including but not limited to pellucid marginal degeneration); (3) with significant dry eyes (severe Dry Eye Syndrome). If patients have severely dry eyes, LASIK may increase the dryness. This may or may not go away. Severe eye dryness may delay healing of the flap or interfere with the surface of the eye after surgery. It may result in poor vision after LASIK; (4) for whom the combination of their baseline corneal thickness and the planned operative parameters for the LASIK procedure would result in less than 250µ of residual corneal thickness from corneal endothelium; (5) with uncontrolled diabetes; (6) with uncontrolled glaucoma; (7) with active eye infections or active inflammation: (8) with recent herpes eye infection or problems resulting from past infections; (9) with known sensitivity to medications used for standard LASIK surgery.

Potential Risks and Side Effects: (1) Miscreated flap; (2) Subconjunctival hemorrhage or bleeding; (3) Wrinkles in flap that may require a flap lift; (4) Corneal erosion/abrasion, epithelia defect; (5) Elevated IOP; (6) Debris or foreign body under flap; (7) Epithelial ingrowth under flap; (8) Debilitating visual symptoms, especially at night; (9) Decreased or fluctuating visual acuity; (10) Decreased ability to see in low-light conditions; (11) Light sensitivity; (12) Dry Eye syndrome; (13) Inadequate treatment result; (14) Regression; (15) Corneal damage; (16) Posterior vitreous detachment or retinal detachment, floaters or vascular accidents; (17) Foreign body sensation or pain (initial postoperative days); also, potentially including chronic eye pain that is resistant to therapy referred to as neuropathic pain; (18) Infection/inflammation; (19) CTK (Central Toxic Keratopathy); (20) Medication intolerance; (21) Ptosis; (22) Cataract; (23) Ocular penetration; (24) Potential risk of psychological harm.

This is not all you need to know. Please see the User Manual for a complete list of safety information, including a full list of contraindications, warnings, precautions and risks.

Caution: Federal (U.S.) law restricts this device to sale, by or on the order of a physician.

For more information visit https://www.bauschsurgical.com/refractive/teneo/.

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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.

*Myopia between -1 and -10 diopters (D) with astigmatism between 0 and -3 D.
**Based upon calculation using an Optical Zone of 6mm and a standard myopic treatment (PROSCAN mode) 

References

  1. Waring et al. Safety and effectiveness of laser in situ Keratomileusis using Teneo 317 Model 2 for correcting myopia and myopic astigmatism: Results of the US FDA clinical trial. J Refract Surg. 2024;40(8):e544–e553

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