Mr. Brent Saunders reports

BAUSCH + LOMB AND NOVALIQ ANNOUNCE FDA APPROVAL OF MIEBO (PERFLUOROHEXYLOCTANE OPHTHALMIC SOLUTION) FOR THE TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE

Bausch + Lomb Corp. and Novaliq GmbH, a biopharmaceutical company focusing on first-in-class and best-in class ocular therapeutics, have received U.S. Food and Drug Administration approval for Miebo (perfluorohexyloctane ophthalmic solution; formerly known as NOV03), for the treatment of the signs and symptoms of dry eye disease (DED). Miebo is the first and only FDA-approved treatment for DED that directly targets tear evaporation.

"Today's FDA approval of Miebo further advances DED treatment by addressing a significant unmet need for millions of people suffering with this disease," said Brent Saunders, chairman and chief executive officer of Bausch + Lomb. "We are proud to bring to market the first and only prescription eye drop approved in the United States for the treatment of DED that directly targets evaporation. We expect to make Miebo commercially available in the second half of this year."

DED affects millions of Americans and is one of the most common ocular surface disorders. A leading cause of DED is excessive tear evaporation, which, due to an altered tear lipid layer, is often associated with the clinical signs of meibomian gland dysfunction (MGD). An unstable tear film triggers increased ocular surface desiccation, inflammation and damage to the ocular surface. Miebo is designed to reduce tear evaporation at the ocular surface.

In Gobi and Mojave, two phase 3 pivotal clinical trials that enrolled more than 1,200 patients (randomized 1:1 to Miebo or hypotonic saline) with a history of DED and clinical signs of MGD, Miebo consistently met its primary clinical sign and patient-reported symptom end point.

"In the two pivotal clinical trials, Miebo addressed the persistent and chronic nature of DED by providing sustained improvement in both the signs and symptoms of DED," said Dr. Preeya Gupta, MD, cornea and cataract surgeon, Triangle Eye Consultants, Raleigh, N.C. "Because Miebo inhibits evaporation, it may be an appropriate treatment option for patients whose tear evaporation exceeds tear supply."

"Tear evaporation, which is a leading driver of DED, presents a significant treatment challenge. With the approval of Miebo, eye care professionals can now take a new approach to DED therapy with a first-in-class water- and preservative-free prescription treatment option that specifically addresses tear evaporation," said Dr. Paul Karpecki, OD, director, cornea and external disease, Kentucky Eye Institute, and associate professor, University of Pikeville, Kentucky College of Optometry.

Miebo clinical data

The FDA approval of Miebo was based on results from two 57-day, multicentre, randomized, double-masked, saline-controlled studies, Gobi and Mojave, which enrolled a total of 1,217 patients with a history of DED and clinical signs of MGD, a major cause of development and disease progression. An estimated 86 per cent of people with DED have excessive tear evaporation whereby MGD is the major contributor.

In the Gobi and Mojave phase 3 pivotal 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 days) 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 day 15 and day 57, a significant reduction in tCFS favouring Miebo was observed in both studies.

The most common adverse reactions experienced with Miebo were blurred vision (1.3 per cent to 3 per cent) and eye redness (1 per cent to 3 per cent).

Additional executive commentary

"Today's FDA decision marks a tremendous milestone for Bausch + Lomb as Miebo becomes our first prescription pharmaceutical eye treatment to be approved by the FDA since becoming an independent, publicly traded eye health company," said Andrew Stewart, president, ophthalmic pharmaceuticals, Bausch + Lomb. "We are proud to further deliver on our promise to bringing innovative new options to help patients improve their treatment journey."

"Bausch + Lomb is deeply committed to bringing forward medicines that address unmet medical needs, and Miebo is a prime example of this commitment being realized," said Dr. Yehia Hashad, MD, executive vice-president, research and development, and chief medical officer of Bausch + Lomb. "We are extremely grateful to all of our collaborators, including trial patients, clinical investigators, and our R&D team, for their tireless contributions to this important milestone."

"We believe that Miebo will address a significant unmet need for the many Americans who struggle with evaporative dry eye," said Dr. Christian Roesky, PhD, chief executive officer of Novaliq. "We are grateful to Bausch + Lomb for their continued collaboration in bringing this unique new treatment option to market."

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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