Mr. Andrew Stewart reports

BAUSCH + LOMB LAUNCHES MIEBO(TM) (PERFLUOROHEXYLOCTANE OPHTHALMIC SOLUTION) IN THE UNITED STATES

Bausch + Lomb Corp. has commercially launched in the United States Miebo (perfluorohexyloctane ophthalmic solution) for the treatment of the signs and symptoms of dry eye disease (DED). Miebo is the first and only prescription eye drop approved for DED that directly targets tear evaporation.

"More and more Americans are suffering from dry eye disease, due in large part to today's multiscreen lifestyles," said Andrew Stewart, president, global pharmaceuticals and international consumer, Bausch + Lomb. "With Miebo, eye care professionals now have a prescription eye drop that directly addresses tear evaporation, the leading cause of dry eye disease."

DED affects more than 38 million Americans, with approximately nine in 10 experiencing evaporative dry eye. When not addressed, tear evaporation may lead to worsening of the condition by triggering a cycle of inflammation and ocular surface damage. Miebo is a single-ingredient, water-, preservative- and steroid-free prescription eye drop that spreads quickly and comfortably. It is designed to address the signs and symptoms of DED by reducing tear evaporation at the ocular surface.

The U.S. Food and Drug Administration (FDA) approved Miebo in May, 2023, based on consistent results from two pivotal phase 3 trials. Its clinical development program includes the first and only phase 3 program for any FDA-approved prescription DED product composed entirely of patients with both DED and clinical signs of Meibomian gland dysfunction (MGD). MGD is a major cause of DED development and progression, with approximately 86 per cent of people with DED having excessive tear evaporation associated with MGD. In the clinical trials, Miebo delivered significant improvements in the signs and symptoms of DED and consistently met its primary clinical sign and patient-reported symptom end point. The most common adverse reactions experienced with Miebo was blurred vision (1 per cent to 3 per cent of patients reported blurred vision and eye redness).

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).

Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA website or call 1-800-FDA-1088.

About dry eye disease

DED is a chronic inflammatory ocular surface disease that is commonly characterized by dryness, stinging, burning, grittiness and/or episodes of blurred vision. The two main types of dry eye disease are aqueous deficient and evaporative. Aqueous-deficient dry eye occurs when the eyes do not produce enough tears. Evaporative dry eye is due to a deficient tear film lipid layer. The most common type of dry eye is evaporative.

About Miebo phase 3 clinical trials

FDA approval of Miebo was based on results from two 57-day, multicentre, randomized, double-masked, saline-controlled studies, Gobi and Mojave. The studies assessed a total of 1,217 patients who received Miebo or hypotonic saline (0.6 per cent) in a 1:1 ratio.

In these studies, Miebo met both primary sign and symptom efficacy end points. The two primary end points were change from baseline at week 8 (day 57 plus or minus two) in total corneal fluorescein staining (tCFS) and eye dryness visual analogue scale (VAS) score. Patients experienced relief of symptoms as early as day 15 and through day 57 with statistically significant reduction in VAS eye dryness score favouring Miebo observed in both studies. Additionally, at days 15 and day 57, a significant reduction in tCFS favouring Miebo was observed in both studies.

The most common adverse reactions experienced with Miebo was blurred vision (1 per cent to 3 per cent of patients reported blurred vision and eye redness).

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.

We seek Safe Harbor.