Bausch + Lomb Corporation announced it has officially completed its acquisition of Novartis’s Xiidra (lifitegrast ophthalmic solution) 5% and two other front-of-eye assets.
Refresh me on Xiidra.
FDA-approved in 2016 as a non-steroid eye drop, Xiidra is specifically indicated to treat the signs and symptoms of dry eye disease (DED).
The recommended dosage is one drop twice daily in each eye, administered approximately 12 hours apart, according to the prescribing information.
I could have sworn B+L already has a DED eye drop …
You’re right. The company’s dry eye portfolio already includes various ophthalmic and contact lens topical formulations—including MIEBO (perfluorohexyloctane ophthalmic solution).
To note: MIEBO was just approved by the FDA in May 2023 as the first and only DED treatment directly targeting tear evaporation (compared to Xiidra’s focus on chronic inflammation).
So these two products are different, right?
Absolutely. One targets DED signs and symptoms (Xiidra), while the other targets tear evaporation (MIEBO).
Plus, the dosages differ:
- Xiidra → one drop, twice daily (BID)
- MIEBO→ one drop, four times a day (QID)
Now talk about these ‘front-of-eye’ assets.
B+L’s acquisition also extends to the following:
- Libvatrep (SAF312) → an investigational compound for the treatment of chronic ocular surface pain.
- Currently undergoing phase 2b clinical trial (NCT04630158); results are expected in the second half of 2023.
- OJL332 → a second generation TRPV1 antagonist
- Currently in the pre-clinical development stage
- AcuStream technology → a preservative-free, electromechanical topical ocular delivery device with the potential to coordinate precise dosing and accurate delivery of specific topical ophthalmic medications to the eye.
- To note: Acustream was originally developed by Kedalion Therapeutics before being acquired by Novartis in June 2022.
What else?
Per the agreement, Novartis is continuing to supply Xiidra (on behalf of B+L) for a limited period following in order to ensure consistent supply to patients.
Additionally, B+L has also brought on the sales force associated with Xiidra.
Remind me … how much is this deal worth?
Purchased via an affiliate of B+L, the price tag clicks in at up to $2.5 billion—including an upfront payment of $1.75 billion in cash and potential milestone obligations of up to $750 million that will depend on sales thresholds and pipeline commercialization.
Gotcha. And significance?
This latest deal for Novartis follows the company’ plans to sell off its ophthalmology assets, which was reportedly announced earlier this year.
B+L CEO Brent Saunders stated that, with this deal officially signed and sealed, the company expects to take a “leading position in the growing prescription dry eye category” with the ownership of both DED eye drops.