Bausch + Lomb announces acquisition of Xiidra from Novartis

(Adobe Stock / Alex from the Rock)

Bausch + Lomb has announced that it will acquire Xiidra (liftegrast ophthalmic solution 5%) in a deal with Novartis, which will bolster their foothold in the dry eye disease (DED) space.¹ Bausch + Lomb acquired the non-steroid eye drop, which was specifically approved to treat the signs and symptoms of DED via inflammation management. Under the agreement, Bausch + Lomb will also acquire SAF312 (libvatrep), an investigative therapy for chronic ocular surface pain; AcuStream, a delivery device in dry eye indications; and OJL332, a second generation TRPV1 antagonist in pre-clinical development, from Novartis for $2.5 billion.²

This acquisition was strategic, as Bausch + Lomb looks to fill out its dry eye portfolio, which currently features a slew of eye and contact lens drops and the newly FDA-approved Miebo (perfluorohexyloctane ophthalmic solution). Miebo is the first and only water-free drop to target tear evaporation to relieve signs and symptoms of DED. Both Xiidra and Miebo target signs and symptoms of dry eye, but each targets distinct elements of the DED cycle, making the therapies complementary to Bausch + Lomb’s portfolio.

“This acquisition is a prime example of our strategy in action, as it provides needed scale for the company and transforms our pharmaceuticals business by making us a leader in ocular surface diseases,” Brent Saunders, chairman and CEO, Bausch + Lomb, said in a press release.

“The deal is also expected to accelerate margin expansion through a larger mix of pharmaceutical products in our portfolio, provide strong and immediate earnings accretion and presents a clear path to deleverage, making it financially compelling.”

Under the agreement, Bausch + Lomb acquires Xiidra, libvatrep, AcuStream, and OJL332 from Novartis for up to $2.5 billion. The Board of Directors of each respective company approved the transaction of $1.75 billion in cash upfront with milestone obligations up to $750 million for meeting sales thresholds and pipeline commercialization. Bausch + Lomb is supported by JP Morgan, who will finance the $1.75 billion purchase price with new debt prior to closing. The transaction is expected to close by the end of 2023.

Dry eye disease

Dry eye disease (DED) is one of the most common ocular surface disorders,³ affecting approximately 38 million people in the United States and approximately 739 million people worldwide.⁴ Research has shown a higher prevalence of DED in the US over the past 10 years, including in younger adult populations (ages 18 to 34), largely due to lifestyle changes and more time spent on digital screens.⁵

“Dry eye disease is multifactorial and can stem from varying root causes, which means differing treatment options are needed,” said Marguerite McDonald, MD, FACS, OCLI Vision, Oceanside, NY, in a press release.

“With the acquisition of Xiidra and recent approval of Miebo, Bausch + Lomb enhances its approach to different facets of dry eye and is well positioned to ensure both medicines reach as many patients as possible.”

Over the next five years, the United States’s prescription DED field is expected to grow at a double-digit compounded annual growth rate.⁶ Xiidra is patented through 2033, and generated approximately $487 million in sales in 2022.

Important safety information for Xiidra and Miebo

Do not use Xiidra if you are allergic to any of its ingredients. Seek medical care immediately if you get any symptoms of an allergic reaction.

The most common side effects of Xiidra:

• eye irritation
• discomfort or blurred vision when the drops are applied to the eyes
• an unusual taste sensation.

To help avoid eye injury or contamination of the solution, do not touch the container tip to your eye or any surface. If wearing contact lenses, remove them before using Xiidra and wait for at least 15 minutes before placing them back in your eyes.

It is not known if Xiidra is safe and effective in children under 17 years of age.

For full prescribing information of Xiidra, visit here.

Miebo (perfluorohexyloctane ophthalmic solution) is the first and only water-free drop to target tear evaporation to relieve signs and symptoms of DED.

• Patients should remove contact lenses before using Miebo and wait for at least 30 minutes before reinserting.
• Patients should use Miebo only as prescribed
• It is not known if Miebo is safe and effective in children under the age of 18.
• Blurred vision (1% to 3% of patients reported blurred vision and eye redness) was the most common reported side effect

Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For full prescribing information on Miebo, visit here.

References

1. Bausch + Lomb will acquire XIIDRA. www.bausch.com. June 30, 2023. Accessed June 30, 2023. https://www.bausch.com/news/releases/?id=163

‌2. Novartis signs agreement to divest “front of eye” ophthalmology assets in line with focused strategy. Press release. Novartis.com. June 30, 2023. Accessed June 30, 2023. https://www.novartis.com/news/media-releases/novartis-signs-agreement-divest-front-eye-ophthalmology-assets-line-focused-strategy

3. National Eye Institute. Dry Eye. Last updated April 8, 2022. Accessed May 2, 2023. https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/dry-eye

4. Downs P. 2020 Dry Eye Products Market Report: A Global Analysis for 2019 to 2025. Market Scope; 2020.

5. Modern technology and a multi-screen lifestyle viewed as important factors in rising prevalence of dry eye disease. News release. PR Newswire; October 17, 2016. Accessed October 4, 2022. https://www.multivu.com/players/English/7893551-shire-dry-eye-disease-awareness/

6. U.S. dry-eye size including aqueous supplements, secretagogues, corticosteroids, LFA-1 antagonists, calcineurin inhibitors across anti-inflammatory and non-anti-inflammatory drug classes. Source: DRG (12/2022); Expert interviews; Analyst reports.