Presentations Will Feature Studies Evaluating MIEBO™ (Perfluorohexyloctane Ophthalmic Solution), IC-8® Apthera™ IOL and ARMOR Surveillance Study Data
Company Will Host Six Educational Events
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 three podium presentations and seven poster presentations during the American Academy of Ophthalmology (AAO) annual meeting, which will take place in San Francisco Nov. 3-6, 2023.
Three podium presentations will feature an evaluation of the use of IC-8 Apthera intraocular lens (IOL) in patients with complex cases as well as an analysis of data on the unique Antibiotic Resistance Monitoring in Ocular MicRooganisms (ARMOR) surveillance study, which evaluates trends in antibiotic resistance among common ocular bacterial pathogens across the United States. The poster presentations will also highlight ARMOR study results, as well as the results of studies evaluating IC-8 Apthera IOL, XIPERE® (triamcinolone acetonide injectable suspension) 40 mg/mL and newly launched MIEBO.
Six company-sponsored educational events will focus on these and other Bausch + Lomb products, including the new enVista® Aspire IOL.
The Bausch + Lomb schedule at AAO:
Podium Presentations
“ARMOR Against Antibiotic Resistance: When Treatment Can't Wait.” Asbell et al.
“Evaluation of Visual Outcomes in Patients with Complex Corneas Implanted with a Small Aperture IOL.” Ming et al.
“Small-Aperture Optics and Surgery to Achieve Pinhole Effect: Instructional Course.” Narang et al.
Poster Presentations
“A Novel Small Aperture IOL Provides Monovision with a Continuous Range of Vision.” Yeu et al.
“Experience with Triamcinolone Acetonide Suprachoroidal Injection for Uveitic Macular Edema: A Physician Survey.” Singer et al.
“In Vitro Antibiotic Resistance Among Intraocular Bacterial Pathogens: Results from the ARMOR Study.” Asbell et al.
“NOV03 Eye Drop for Dry Eye Disease: Safety and Efficacy Across Development Studies.” Sheppard et al.
“Prospective Study of Small Aperture IOL Implantation in Eyes with Previous Refractive Procedures.” Ang et al.
“Retinal Visualization in a Small Aperture IOL Treated Eye.” Blecher et al.
“Visual Outcomes with a Small-Aperture IOL in Post Radial Keratotomy Patients.” Sudhinder et al.
Featured Educational Events
Friday, November 3
“The Anti-Evaporative Piece of the Dry Eye Rx Eye Drop Puzzle”
7:30 p.m. PT at Morton’s Steakhouse (400 Post Street, San Francisco)
Join Sheri Rowen, M.D., and Darrell White, M.D., to learn more about MIEBO, the first and only prescription eye drop that directly addresses tear evaporation. Register in advance.
Saturday, November 4
“Industry Showcase: MIEBO – A Different Approach to Treating the Signs and Symptoms of Dry Eye Disease”
12:10-12:40 p.m. PT at Moscone Convention Center (747 Howard Street, San Francisco; North Hall, booth #5302)
Excessive tear evaporation is a leading driver of DED and triggers a vicious cycle of symptoms.1,2,3 Preeya K. Gupta, M.D. and Kenneth A. Beckman, M.D., will lead a conversation on how to directly target tear evaporation with MIEBO prescription eye drops.
“Industry Showcase TED Talk: Complex Cases Made Simple by Unleashing the Power of Dual-Linear Chop”
2:00-2:18 p.m. PT at Moscone Convention Center (747 Howard Street, San Francisco; North Hall, booth #5302)
Reena A. Garg, M.D., and Paul Petelin, Jr., M.D., will discuss the power of independent control of vacuum and ultrasound simplifying traditionally complex cases with dual-linear technology.
“Innovations in Evaporative DED & Novel Cataract Surgery Technologies”
6:00-8:00 p.m. PT at the Hibernia San Francisco (1 Jones Street, San Francisco)
An expert panel, moderated by Eric D. Donnenfeld, M.D., and featuring Mark Lobanoff, M.D., Marguerite McDonald, M.D., and Karl G. Stonecipher, M.D., will review and discuss Bausch + Lomb’s MIEBO prescription eye drops, Apthera™ small aperature IOL and Eyetelligence™ platform. Register in advance.
Sunday, November 5
“Industry Showcase: Elevate the Everyday – Discover Bausch + Lomb’s New IOL”
12:10 – 12:40 p.m. PT at Moscone Convention Center (747 Howard Street, San Francisco; North Hall, booth #5302)
Andrew Jones and George Lau, O.D., will discuss the new enVista® Aspire monofocal and toric intraocular lenses with Intermediate Optimized optics, which combines novel optics, which are designed for a broader depth of focus, with the proven benefits of the Bausch + Lomb enVista platform.
“Industry Showcase TED Talk: The Science of MIEBO (Perfluorohexyloctane Ophthalmic Solution)”
1:00-1:18 p.m. PT at Moscone Convention Center (747 Howard Street, San Francisco; North Hall, booth #5302)
Jason Vittitow, Ph.D., will review the science behind MIEBO, the first and only prescription eye drop that directly addresses tear evaporation.
Important Safety Information for MIEBO
INDICATION
MIEBO™ (perfluorohexyloctane ophthalmic solution) is used to treat the signs and symptoms of dry eye disease.
IMPORTANT SAFETY INFORMATION
Patients should remove contact lenses before using MIEBO™ and wait for at least 30 minutes before reinserting.
It is important for patients to use MIEBO exactly as prescribed.
It is not known if MIEBO™ is safe and effective in children under the age of 18.
The most common eye side effect seen in studies was blurred vision (1% to 3 % of patients reported blurred vision and eye redness).
Click here for full Prescribing Information for MIEBO.
Indications and Important Safety Information for IC-8 Apthera IOL
INDICATIONS: The IC-8 Apthera IOL is indicated for unilateral implantation for the visual correction of aphakia and to create monovision in patients of age 22 or older who have been diagnosed with bilateral operable cataract, who have up to 1.5 D of astigmatism in the implanted eye, and who do not have a history of retinal disease and who are not predisposed to experiencing retinal disease in the future. The device is intended for primary implantation in the capsular bag, in the non-dominant eye, after the fellow eye has already undergone successful implantation (uncorrected distance visual acuity 20/32 or better and best-corrected distance visual acuity 20/25 or better) of a monofocal or monofocal toric IOL that is targeted for emmetropia. The refractive target for the IC-8 Apthera IOL should be -0.75 D. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal or monofocal toric IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity.
CONTRAINDICATIONS: (1) Patients with dilated pupil size less than 7.0 mm. (2) Patients with a history of retinal disease including but not limited to, high myopia, diabetes, macular disease, sickle cell disease, retinal tear, retinal detachment, retinal vein occlusion, ocular tumor, uveitis, and patients who are predisposed to experiencing retinal disease in the future.
WARNINGS: The lens should not be implanted if appropriate intraocular support of the lens is not possible. Severe subjective visual disturbances (e.g., glare, halo, starburst, hazy vision) may occur after device implantation. There is a possibility that these visual disturbances may be significant enough that a patient may request removal of the lens. Contrast sensitivity in eyes implanted with this lens is significantly reduced when compared to the fellow eye implanted with a monofocal or monofocal toric IOL. Although there was no significant reduction in binocular contrast sensitivity in the IDE clinical study, it is essential that prospective patients be fully informed of this visual effect in the implanted eye before giving their consent for unilateral implantation of the lens. Patients should be informed that they may need to exercise caution when engaging in activities that require good vision in dimly lit environments (such as driving at night or in poor visibility conditions). There is a possibility that visual symptoms due to reduced contrast sensitivity may be significant enough that a patient may request removal of the lens. This lens should not be implanted bilaterally because bilateral implantation is expected to cause significant reduction in contrast sensitivity under all lighting conditions. The use of this lens in patients with corneal astigmatism greater than 1.5 D is not recommended. Diagnostic tests in patients implanted with the lens may take longer and require some additional effort from the patient and the physician to perform. Use of some medical lasers to treat certain eye conditions may present potential risks of damaging the FilterRing component of the lens. Removal of the lens may be necessary prior to retinal or vitreal procedures. Surgeons should perform a careful benefit-risk assessment based on individual patient characteristics, weighing all the risks disclosed in the Directions for Use labeling against the benefit of extended depth of focus. Nd:YAG laser capsulotomy treatments may be more difficult to perform and may be less effective in an IC-8 Apthera IOL implanted eye. Specific training from Bausch & Lomb, Inc. or its authorized representative related to YAG capsulotomy is required before a surgeon is authorized to implant the IC-8 Apthera IOL.
PRECAUTIONS: Prior to surgery, prospective patients should be informed of the possible risks and benefits associated with this lens and a Patient Information Brochure should be provided to the patient. Patients with a predicted postoperative astigmatism between 1.0 D and 1.5 D may not obtain as great an amount of improvement in intermediate vision compared to patients with lower amounts of astigmatism.
CAUTION: Federal law restricts this device to sale by or on the order of a licensed physician.
ATTENTION: Reference the Directions for Use labeling for a complete listing of important safety information.
Important Safety Information about XIPERE
INDICATION
XIPERE (triamcinolone acetonide injectable suspension) for suprachoroidal use is a corticosteroid indicated for the treatment of macular edema associated with uveitis.
IMPORTANT SAFETY INFORMATION
Patients should be monitored following injection for elevated intraocular pressure. See Dosage and Administration instructions in full Prescribing Information.
XIPERE is contraindicated in patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
XIPERE is contraindicated in patients with known hypersensitivity to triamcinolone acetonide or any other components of this product.
Use of corticosteroids may produce cataracts, increased intraocular pressure, and glaucoma. Use of corticosteroids may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses, and should be used cautiously in patients with a history of ocular herpes simplex.
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and hyperglycemia can occur following administration of a corticosteroid. Monitor patients for these conditions with chronic use.
In controlled studies, the most common ocular adverse reactions were increased ocular pressure, non-acute (14%), eye pain, non-acute (12%), cataract (7%), increased intraocular pressure, acute (6%), vitreous detachment (5%), injection site pain (4%), conjunctival hemorrhage (4%), visual acuity reduced (4%), dry eye (3%), eye pain, acute (3%), photophobia (3%), and vitreous floaters (3%), and in 2% of patients: uveitis, conjunctival hyperaemia, punctate keratitis, conjunctival oedema, meibomianitis, anterior capsule contraction, chalazion, eye irritation, eye pruritus, eyelid ptosis, photopsia, and vision blurred.
The most common non-ocular adverse event was headache (5%).
Corticosteroids should be used during pregnancy or nursing only if the potential benefit justifies the potential risk to the fetus or nursing infant.
To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit .
Please click here for full Prescribing Information.
About Bausch + Lomb
Bausch + Lomb is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Its comprehensive portfolio of more than 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 and connect with us on Twitter, LinkedIn, Facebook and Instagram.
Forward-looking Statements
This news release may contain forward-looking statements, which may generally be identified by the use of the words “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “estimates,” “potential,” “target,” or “continue” 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
Craig JP, Nelson JD, Azar DT, et al. TFOS DEWS II report executive summary. Ocul Surf. 2017;15(4):802-812. doi:10.1016/j.jtos.2017.08.003.
Lemp MA, Crews LA, Bron AJ, Foulks GN, Sullivan BD. Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study. Cornea. 2012;31(5):472-478. doi:10.1097/ICO.0b013e318225415a.
Pflugfelder SC, de Paiva CS. The pathophysiology of dry eye disease: what we know and future directions for research. Ophthalmology. 2017;124(11S):S4-S13. doi:10.1016/j.ophtha.2017.07.010.
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