Bausch + Lomb Announces Publication of Data From a Prospective Study Evaluating the Efficacy of XIIDRA® in Alleviating Discomfort in Symptomatic Contact Lens Wearers

• XIIDRA significantly improved end-of-day eye dryness and discomfort and delivered longer comfortable contact lens wear time in as little as two weeks
• Continued use further improved discomfort

Bausch + Lomb Corporation (NYSE/TSX:BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced Clinical Ophthalmology has published results from an investigator-initiated study which evaluated the effectiveness of XIIDRA (lifitegrast ophthalmic solution) 5% in alleviating end-of-day (EOD) eye dryness and discomfort in symptomatic contact lens (CL) wearers.* XIIDRA is a prescription eye drop used to treat the signs and symptoms of dry eye disease (DED) by targeting a source of inflammation. These results reinforce the results from four previous clinical studies which demonstrated that XIIDRA significantly reduced symptoms of eye dryness over 12 weeks.

"Although the use of OTC rewetting drops provides temporary relief for some wearers, their benefit is only moderate and contact lens discomfort typically worsens as the day progresses," said Andrew Stewart, president, Global Pharmaceuticals and International Consumer, Bausch + Lomb. "This study showed that XIIDRA may be a suitable alternative for symptomatic contact lens wearers who can't achieve comfort or relieve dryness by switching their contact lenses or using OTC drops."

The investigator-initiated, prospective, open-label study evaluated whether comfort and dryness in symptomatic soft CL wearers improved after using XIIDRA twice a day for 12 weeks while continuing to wear their usual contact lenses. In total, 40 participants completed the study, which assessed the performance of XIIDRA by comparing ratings on a visual analog scale (VAS; 0-100 scale; 100 worst) at two, six and 12 weeks for EOD dryness and discomfort and Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) scores to baseline levels.

Key points from the trial (for all results P<0.01):

• The study met its primary endpoints and showed that there was a significant improvement in CL wear-related EOD eye dryness and discomfort over time.
  • Median VAS scores improved by 61 and 59 points on a 100-point scale for EOD dryness and discomfort, respectively, after 12 weeks of XIIDRA use.
  • XIIDRA use also resulted in a significant reduction in CL wear-related EOD eye dryness and discomfort after two and six weeks compared to baseline.
  • EOD dryness symptoms improved in about half of the 40 study participants (18/40 = 45%) to such a degree that they would not have met the symptom-related eligibility criteria for this study after just two weeks of treatment.
• XIIDRA use resulted in statistically significantly reduced CLDEQ-8 scores in comparison to baseline at the 2-week, 6-week and 12-week follow-up visit.
  • There was a 6-point reduction in CLDEQ-8 scores for the symptomatic wearers of 17 different contact lens types after just two weeks, with CLDEQ-8 scores continuing to decrease over the 12-week study period.
  • After 12 weeks, 90% of participants achieved a clinically meaningful improvement of at least three points in CLDEQ-8 scores compared to baseline.
• Significant improvement in ratings for each of the five VAS symptoms of burning/stinging, itching, foreign body sensation, photophobia and pain was seen as early as two weeks of XIIDRA use and continued throughout the study period.
• XIIDRA use showed an increase in mean comfortable CL wear time (6.5 hours at baseline compared to 9.1 hours at 12 weeks, respectively).
  • There were no changes in total wear time during the study.
• Study findings indicated that XIIDRA could be safely used by CL wearers.

XIIDRA was well tolerated with two reports of treatment-related adverse events.

"The significant improvements in symptoms of end-of-day dryness and discomfort for contact lens wearers in as little as two weeks highlighted the effectiveness of XIIDRA, even after a short period of use," said Marc-Matthias Schulze, Ph.D., principal investigator and senior clinical scientist at Centre for Ocular Research & Education (CORE) at the School of Optometry and Vision Science, University of Waterloo in Waterloo, ON. "Additionally, results showed continued use of XIIDRA throughout the study further improved symptoms, demonstrating that XIIDRA remains an effective treatment over time and may allow contact lens wearers to enjoy their lenses throughout the entire day."

For more information on XIIDRA, visit www.xiidra.com.

*The study was investigator-initiated and independently conducted by CORE at the University of Waterloo, with Bausch + Lomb providing study medication and support.

Study limitations: Single-center, open-label design, lack of control group. Participants used ATs or rewetting drops ≥1 time in month prior to study start; it is possible that more frequent use of XIIDRA vs previous drops in some patients could have contributed to symptom reduction. Data should be interpreted with the study design and these limitations in mind. No formal conclusions should be drawn.

WHAT IS XIIDRA?

XIIDRA (lifitegrast ophthalmic solution) 5% is a prescription eye drop used to treat the signs and symptoms of dry eye disease.

IMPORTANT SAFETY INFORMATION

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 include eye irritation, discomfort or blurred vision when the drops are applied to the eyes, and 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 you wear 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.

Click here for full Prescribing Information for XIIDRA.

About Bausch + Lomb

Our mission is simple – we help people see better to live better, all over the world. For nearly two centuries, we've evolved with the changing needs of patients and customers, and our commitment to innovation and improving the standard of care in eye health has never been stronger. From contact lenses to prescription products, over-the-counter options, surgical devices and more, we're turning bold ideas into better outcomes through passion, perseverance and purpose. Learn more at www.bausch.com and connect with us on Facebook, Instagram, LinkedIn, X and YouTube.

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