Non-settling gel preparation delivers uniform dose without shaking

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The new gel formulation of loteprednol etabonate 0.5% (Lotemax Gel, Bausch + Lomb) is a non-settling preparation that provides dose uniformity without need for shaking.

By Cheryl Guttman Krader; Reviewed by Ehsan Sadri, MD

Newport Beach, CA-A new gel formulation of loteprednol etabonate 0.5% (Lotemax Gel, Bausch + Lomb) is a valuable addition to the post-laser vision correction surgery medication regimen, according to Ehsan Sadri, MD.

“Controlling inflammation is critical for achieving good outcomes after laser vision correction surgery, because inflammation is associated with pain, delayed visual recovery, development of haze, and a risk of regression,” said Dr. Sadri, private practice, Atlantis Eyecare, Newport Beach, CA. “Therefore, a topical corticosteroid is standard for postoperative treatment of patients who have had LASIK or a surface ablation procedure.

“I consider the new gel formulation of loteprednol etabonate a game changer in these cases, because its novel vehicle brings multiple advantages that build onto the efficacy and safety of the C-20-ester steroid,” he said. “With refractive surgery patients where surgeons are aiming to provide a ‘wow factor’ that will generate word-of-mouth referrals, loteprednol etabonate gel really comes through.”

Non-settling gel preparation

Although the suspension formulation of loteprednol etabonate was very effective for controlling inflammation after laser refractive surgery, the new non-settling gel preparation assures that the patient receives a uniform dose with every instilled drop and without any need for shaking.

Homogenous distribution of the active ingredient in a suspension depends on optimal agitation of the bottle prior to use, Dr. Sadri noted. However, studies have shown that most patients do not follow instructions to ‘shake well’, and that with failure to do so, the administered dose may be suboptimal early in the course of therapy and increase in concentration toward the end. Additionally, drop size with a suspension can vary, depending on how forcibly the bottle is squeezed, so that overuse of the medication is an issue.

Viscosity characteristics

“As a result of the viscosity and non-settling characteristics of the new gel formulation, patients receive the same effective dose of loteprednol etabonate with each instillation,” he said.

Even though it is a gel, this new formulation of loteprednol has adaptive viscosity characteristics that favor ocular surface retention while minimizing the potential for causing bothersome blur. The product is a semisolid gel in the bottle, but dispenses as a drop, thinning to a liquid when exposed to shearing forces as it is squeezed through the tip. On mixing with the tear film, the gel is converted to a liquid on the ocular surface. Therefore, it minimizes problems with the flap or blur, and yet the product retains sufficient viscosity for increased residence time.

The gel is also very comfortable and ocular surface-friendly. It has a pH of 6.5 (versus 5.5 for the suspension), incorporates glycerin and propylene glycol, which have known demulcent and lubricating benefits, and contains a low concentration of benzalkonium chloride (0.007% versus 0.01% in the suspension).

Dr. Sadri said he typically prescribes loteprednol etabonate 0.5% twice daily in his refractive surgery patients and combines it with a nonsteroidal anti-inflammatory drug, for which he has been using bromfenac 0.09% (Bromday, Bausch + Lomb) once daily and recently switched to the new 0.07% formulation (Prolensa, Bausch + Lomb). The postoperative treatment duration for the corticosteroid ranges from 4 to 6 weeks in LASIK patients and is up to 3 months after LASEK or PRK as the risk for inflammation-related collagen deposition and haze is greater after those procedures.

“Since loteprednol etabonate has low potential to raise IOP, it has been the go-to steroid for situations where a steroid-induced IOP response is a concern, including when longer treatment courses are needed,” Dr. Sadri said.

In order to confirm his anecdotal impressions of the benefits of the new gel formulation of loteprednol etabonate, Dr. Sadri has undertaken a prospective, fellow eye-controlled study in which 20 consecutive patients undergoing bilateral LASIK are using the suspension formulation in one eye and the gel contralaterally.

“The study has yet to be completed, but so far, the results with the gel are great,” Dr. Sadri said. “Patients love the comfort of this new formulation and are not expressing any complaints about visual blur.”

Ehsan Sadri, MD

E: esadrii@gmail.com

Dr. Sadri is a consultant to Abbott Medical Optics and Bausch + Lomb.