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2/25/2019, Monday

Media Contact:
Kristy Marks
Kristy.marks@bausch.com
(908) 927-0683

BAUSCH + LOMB ANNOUNCES FDA APPROVAL OF LOTEMAX® SM (LOTEPREDNOL ETABONATE OPHTHALMIC GEL) 0.38% FOR THE TREATMENT OF POSTOPERATIVE INFLAMMATION AND PAIN FOLLOWING OCULAR SURGERY

Designed with SM Technology for Efficient Penetration at a Low Preservative (BAK) Level1,2

 

BRIDGEWATER, N.J., Feb. 25, 2019 – Bausch + Lomb, a leading global health company, today announced that the U.S. Food and Drug Administration (FDA) has approved LOTEMAX® SM (loteprednol etabonate ophthalmic gel) 0.38%, a new gel formulation for the treatment of postoperative inflammation and pain following ocular surgery.1 LOTEMAX SM was expertly formulated using novel SubMicron (SM) Technology to control ocular pain and inflammation after all ocular surgeries. Compared to LOTEMAX® GEL (loteprednol etabonate ophthalmic gel) 0.5%, LOTEMAX SM delivers a submicron particle size for faster drug dissolution in tears,3,4 and provides two times greater penetration to the aqueous humor.2

 

“More than 20 years ago, Bausch + Lomb introduced the first formulation of loteprednol etabonate. Since then, we have continued to advance formulations that meet the changing needs of eyecare professionals and their patients, culminating in LOTEMAX SM, our most advanced loteprednol etabonate formulation to date,” said Tracy Valorie, general manager and senior vice president, U.S. Pharmaceuticals and Surgical, Bausch + Lomb. “We plan to make LOTEMAX SM available by April 2019.”

Based on Bausch + Lomb’s history and experience in loteprednol etabonate innovation over the last two decades, the company developed LOTEMAX SM, which uses SubMicron (SM) Technology to adhere to the ocular surface and then penetrate key ocular tissues.2,6 The submicron particles in LOTEMAX SM help improve drug exposure into the aqueous humor.2 Similar to LOTEMAX GEL, LOTEMAX SM was formulated with patients in mind, with moisturizing ingredients (glycerin and propylene glycol),6 a pH close to that of human tears7 and the lowest preservative percentage (0.003% benzalkonium chloride [BAK]), in a loteprednol etabonate formulation.1,5,8-12

“Patients undergoing ocular surgery, including cataract surgery, often experience inflammation that needs to be treated. This inflammation can be painful and result in serious complications,” said Marguerite McDonald, M.D., F.A.C.S., ophthalmologist and clinical professor of ophthalmology, New York University (NYU) School of Medicine. “In two clinical trials, LOTEMAX SM was significantly more effective than vehicle in completely resolving ocular inflammation and pain following cataract surgery, one of the most common operations performed in the United States. LOTEMAX SM provides proven efficacy, efficient penetration, and less frequent dosing than LOTEMAX GEL, and the tolerability profile that we have come to expect from the loteprednol etabonate molecule. Together these factors support LOTEMAX SM as an important new option for many of my patients who require treatment for inflammation and pain following ocular surgery.”

LOTEMAX SM Clinical Data
The FDA approval of LOTEMAX SM was based on data from two randomized, multicenter, double-masked, parallel-group, vehicle-controlled studies in 742 patients with postoperative inflammation following cataract surgery.1 LOTEMAX SM was administered three times daily to the affected eye beginning the day after surgery and was shown to be significantly more effective than vehicle in completely resolving ocular inflammation and pain following cataract surgery.1 In these two studies, twice as many patients treated with LOTEMAX SM achieved complete inflammation resolution at day eight compared to vehicle (30 percent vs. 15 percent, p<0.0001).1 Additionally, significantly more patients treated with LOTEMAX SM were pain-free compared to vehicle at day eight (74 percent vs. 49 percent, p<0.0001) and day three (secondary endpoint; 72 percent vs. 50 percent, p<0.0001).1,13 

In the studies, LOTEMAX SM had a proven safety profile. There were no treatment-emergent adverse drug reactions that occurred in more than one percent of the subjects in the three times daily group compared to vehicle. 

INDICATION
LOTEMAX® SM (loteprednol etabonate ophthalmic gel) 0.38% is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.

IMPORTANT SAFETY INFORMATION

  • LOTEMAX® SM, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.
  • Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. If LOTEMAX® SM is used for 10 days or longer, IOP should be monitored.
  • Use of corticosteroids may result in posterior subcapsular cataract formation.
  • The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those with diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.
  • Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infections.
  • Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).
  • Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal cultures should be taken when appropriate.
  • Contact lenses should not be worn when the eyes are inflamed.
  • There were no treatment-emergent adverse drug reactions that occurred in more than 1% of subjects in the three times daily group compared to vehicle

 

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

Click here for Prescribing Information for LOTEMAX® SM.

About Bausch + Lomb
Bausch + Lomb, a wholly owned subsidiary of Bausch Health Companies Inc., is a leading global eye health organization that is solely focused on helping people see. Its core businesses include over-the-counter products, dietary supplements, eye care products, ophthalmic pharmaceuticals, contact lenses, lens care products, ophthalmic surgical devices and instruments. Bausch + Lomb develops, manufactures and markets one of the most comprehensive product portfolios in the industry, which is available in more than 100 countries. For more information, visit www.bausch.com.  

References

  1. LOTEMAX SM [prescribing information]. Bridgewater, NJ: Bausch & Lomb Incorporated. 
  2. Cavet ME, Glogowski S, DiSalvo C, Richardson ME. Ocular pharmacokinetics of submicron loteprednol etabonate ophthalmic gel 0.38% following topical administration in rabbits. Invest Ophthalmol Vis Sci. 2015;56(7):1524.
  3. Khadka P, Ro J, Kim H, et al. Pharmaceutical particle technologies: an approach to improve drug solubility, dissolution and bioavailability. Asian J Pharm Sci. 2014;9(6):304-316.
  4. Phillips E, Coffey MJ, Shawer M. Viscoelastic and dissolution characterization of submicron loteprednol etabonate ophthalmic gel, 0.38%. Invest Ophthalmol Vis Sci. 2015;56(7):1525.
  5. Compared to LOTEMAX GEL [prescribing information]. Bridgewater, NJ: Bausch & Lomb Incorporated.
  6. Coffey MJ, DeCory HH, Lane SS. Development of a non-settling gel formulation of 0.5% loteprednol etabonate for anti-inflammatory use as an ophthalmic drop. Clin Ophthalmol. 2013;7:299-312.
  7. Fong R, Silverstein BE, Peace JH, Williams JI, Vittitow JL. Submicron loteprednol etabonate ophthalmic gel 0.38% for the treatment of inflammation and pain after cataract surgery. J Cataract Refract Surg. 2018;44(10):1220-1229.
  8. LOTEMAX ophthalmic suspension [prescribing information]. Bridgewater, NJ: Bausch & Lomb Incorporated.
  9. LOTEMAX OINTMENT [prescribing information]. Bridgewater, NJ: Bausch & Lomb Incorporated.
  10. Alrex [prescribing information]. Bridgewater, NJ: Bausch & Lomb Incorporated.
  11. Zylet [prescribing information]. Bridgewater, NJ: Bausch & Lomb Incorporated.
  12. Inveltys [prescribing information]. Waltham, MA. Kala Pharmaceuticals, Inc.
  13. Data on File

 

 

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LOTEMAX is a trademark of Bausch & Lomb Incorporated or its affiliates. 
Any other product/brand names are trademarks of the respective owners.
© 2019 Bausch & Lomb Incorporated.
LSM.0031.USA.19

 

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