Dr. Yehia Hashad reports

BAUSCH + LOMB ANNOUNCES NEW SCIENTIFIC DATA AND ANALYSES FEATURING CONSUMER, VISION CARE AND PHARMACEUTICAL PRODUCTS WILL BE PRESENTED DURING AMERICAN OPTOMETRIC ASSOCIATION'S OPTOMETRY'S MEETING

Researchers will present the results of 11 scientific poster presentations involving Bausch + Lomb Corp.'s consumer, vision care and pharmaceutical products during the American Optometric Association (AOA) Optometry's Meeting e-posters virtual event, which is taking place from June 13 to 14, 2023. In addition, the company will host several sponsored education events at the Optometry's Meeting in Washington, D.C., from June 21 to 24, 2023.

The poster presentations will include data from the two pivotal phase 3 trials, Gobi and Mojave, and 12-month Kalahari safety extension study of Miebo (perfluorohexyloctane ophthalmic solution). Miebo was approved by the U.S. Food and Drug Administration on May 18, 2023, for the treatment of the signs and symptoms of dry eye disease (DED). It is the first and only FDA-approved prescription eye drop that directly targets tear evaporation in individuals with DED. Three posters will highlight the benefits of new Biotrue hydration boost contact lens rehydrating drops, and two others will feature new data on the company's recently launched Bausch + Lomb Infuse multifocal silicone hydrogel (SiHy) daily disposable contact lenses designed for presbyopic patients: a comparison of the power profiles across the near, intermediate and distance vision zones and an eye care practitioner fitting assessment of the lens.

"Bausch + Lomb is committed to investing in, and bringing to market, new innovations that help eye care practitioners meet the evolving vision needs of their patients," said Yehia Hashad, MD, executive vice-president, research and development and chief medical officer, Bausch + Lomb. "We will share some of these new innovations, including Miebo, Biotrue hydration boost for contacts, and Bausch + Lomb Infuse multifocal lenses, with attendees during the Optometry's Meeting. We also look forward to presenting a variety of new data on these products and some of our other consumer and pharmaceutical products, as well as hosting attendees at our education events."

The complete list of scientific e-poster presentations, as well as details for the featured education events, is as follows:

E-poster presentations:

• "A New Preservative-free Lubricating and Rewetting drop with Antioxidant Erythritol Protects Hyaluronan (HA) from Free Radicals," Siverling et al.;
• "Clinical Evaluation of the Safety and Tolerability of Lumify Eye Illuminations(TM) (LEI) Cosmetic Products," Wesley et al.;
• "Clinical Performance of Unique Preservative Free Contact Lens Lubricating and Rewetting Drop," Shafer et al.;
• "Contemporary Progressive Daily Disposable Silicone Hydrogel Multifocal Contact Lenses: A Comparison of Power Profiles Across Near, Intermediate and Distance Zones," Reindel et al.;
• "Cumulative Irritation Testing and Repeated Insult Patch Testing with Lumify Eye Illuminations(TM) (LEI) Cosmetic Products," Wesley et al.;
• "Hyaluronan (HA) from a new preservative-free lubricating and rewetting drop is retained and released by conventional and silicone hydrogel contact lenses," Scheuer et al.;
• "Latanoprostene bunod 0.024 per cent in patients switched from prior pharmacotherapy: a multicenter retrospective chart review," Cothran et al.;
• "Long-term Safety and Efficacy of NOV03 (Perfluorohexyloctane) for the Treatment of Patients with Dry Eye Disease Associated with Meibomian Gland Dysfunction: the Kalahari Study," Evans et al.;
• "Perfluorohexyloctane (NOV03) for Dry Eye Disease Associated with Meibomian Gland Dysfunction: In Vitro Inhibition of Evaporation," Vollmer et al.;
• "Perfluorohexyloctane (NOV03) for Dry Eye Disease Associated with Meibomian Gland Dysfunction: Pooled Analysis of Gobi and Mojave Studies," Fahmy et al.;
• "Practitioner Assessment of Fitting a Novel Silicone Hydrogel Daily Disposable Multifocal Contact Lens," Rah et al.

Featured education events

Wednesday, June 21:

• "Showcasing Inflammation and IOP Control" -- 7 p.m. ET at Del Frisco's (950 St. NW, suite 501, Washington, D.C.). Derek Cunningham, OD, and Justin Schweitzer, OD, will discuss the benefits of using Lotemax SM (loteprednol etabonate ophthalmic gel), 0.38 per cent, and Vyzulta (latanoprostene bunod ophthalmic solution), 0.024 per cent.

Thursday, June 22:

• "Eyeing Up Evaporation: Getting at the Heart of Dry Eye Disease" -- 8 a.m. to 9 a.m. ET in room No. 207B (level 2) in the Walter E. Washington Convention Center. Jade Coats, OD, and James Deom, OD, will discuss current thinking on the role of evaporation in DED, reviewing causative factors, DED pathophysiology, diagnostic approaches and current treatments.
• "Believe in the Power of Multifocals: Introducing Bausch + Lomb Infuse Multifocal" -- 12 p.m. to 1 p.m. ET in room No. 207B (level 2) in the Walter E. Washington Convention Center. Mile Brujic, OD, and Paul Karpecki, OD, will lead a conversation on the new Bausch + Lomb Infuse multifocal contact lenses, which were designed to directly address the common problems that presbyopic patients experience with multifocal lenses, including contact lens dryness.
• "All Eyes on Evaporation" -- 7 p.m. ET at Mastro's Steakhouse (600 13th St. NW, Washington, D.C.). Melissa Barnett, OD, and Dr. Karpecki, OD, will discuss current thinking on the role of evaporation in DED, reviewing causative factors, DED pathophysiology diagnostic approaches and current treatments.

Friday, June 23:

• "Showcasing Inflammation and IOP Control" -- 8 a.m. to 9 a.m. ET in room No. 207A (level 2) in the Walter E. Washington Convention Center. Nora Cothran, OD, and Jessica Steen, OD, will discuss two of the company's pharmaceutical advancements: Lotemax SM (loteprednol etabonate ophthalmic gel), 0.38 per cent, and Vyzulta (latanoprostene bunod ophthalmic solution), 0.024 per cent.
• "Bausch + Lomb Practice Pearls & Innovative Products" -- 12 p.m. to 1 p.m. ET in room No. 207A (level 2) in the Walter E. Washington Convention Center. Ben Gaddie, OD, and Dr. Brujic, OD, FAAO, will share practical patient cases using products from across the Bausch + Lomb consumer, vision care and pharmaceutical portfolios.

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 per cent to 3 per cent of patients reported blurred vision and eye redness).

Important safety information for Lotemax SM

Indication

Lotemax SM (loteprednol etabonate ophthalmic gel), 0.38 per cent, is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery.

Important safety information:

• Lotemax SM, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.
• Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. If Lotemax SM is used for 10 days or longer, IOP (intraocular pressure) should be monitored.
• Use of corticosteroids may result in posterior subcapsular cataract formation.
• The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those with diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.
• Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infections.
• Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).
• Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal cultures should be taken when appropriate.
• Contact lenses should not be worn when the eyes are inflamed.
• There were no treatment-emergent adverse drug reactions that occurred in more than 1 per cent of subjects in the three times daily group compared with vehicle.

Important safety information for Vyzulta

Indication

Vyzulta (latanoprostene bunod ophthalmic solution), 0.024 per cent, is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Important safety information:

• Increased pigmentation of the iris and periorbital tissue (eyelid) can occur. Iris pigmentation is likely to be permanent.
• Gradual changes to eyelashes, including increased length, increased thickness and number of eyelashes, may occur. These changes are usually reversible upon treatment discontinuation.
• Use with caution in patients with a history of intraocular inflammation (iritis/uveitis). Vyzulta should generally not be used in patients with active intraocular inflammation.
• Macular edema, including cystoid macular edema, has been reported during treatment with prostaglandin analogs. Use with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule or in patients with known risk factors for macular edema.
• There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products that were inadvertently contaminated by patients.
• Contact lenses should be removed prior to the administration of Vyzulta and may be reinserted 15 minutes after administration.
• Most common ocular adverse reactions with incidence greater than or equal to 2 per cent are conjunctival hyperemia (6 per cent), eye irritation (4 per cent), eye pain (3 per cent) and instillation site pain (2 per cent).

Patients are encouraged to report negative side effects of these prescription drugs to the FDA.

About Bausch + Lomb Corp.

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, Ont., with corporate offices in Bridgewater, N.J.

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