Lotemax Gel ( Loteprednol Etabonate Gel )
According to presentation at the ARVO (Association for Research in Vision and Ophthalmology) annual meeting in Fort Lauderdale, Florida 2012, a new Corticosteroid Gel (Loteprednol Etabonate Gel, 0.5%) can be used to treat intraocular inflammation after cataract surgery.
Bausch+Lomb presents Loteprednol Etabonate Gel Formulation which acts as anti-inflammatory drug and reduces inflammatory cells in the anterior chamber after cataract surgery and also reduce pain and redness.
Multicenter clinical studies were held on 810 patients who underwent cataract surgery. Patients who used Loteprednol gel showed significant resolution of inflammatory cells in the anterior chamber of the eye with no pain at day 8 of the study till day 18 compared with patients who were treated with placebo.
Mild side effects such as red eye and foreign body sensation were resolved at the end of the study. The mean intraocular pressure between the two groups were similar and no serious ocular and systemic side effects were reported.
Loteprednol Etabonate is a known anti-inflammatory medication and was approved in 1998 by the FDA for the treatment of inflammation following ocular surgery such as cataract surgery. It is used worldwide as a suspension under the name of Lotemax. It can also be used in ocular diseases such as allergic conjunctivitis and iritis.
What are the advantages of the new Lotemax gel formulation?
1- Viscosity. Increase the duration of contact between the drug and ocular surface.
2- Suspension formulations required shaking the bottle before applying the drug to the eye while gel it is not required in gel formulation.
3- The drug particles can settle within the suspension form but not the gel form.
4- PH of the gel form is closer to that of ocular surface and tears.
5- Suspension form has 0.01% of preservative BAK (Benzalkonium Chloride) while the gel form has 0.003%. Preservative can be harmful for the epithelial surface of the cornea.
On October, 2012, The U.S. Food and Drug Administration (FDA) has approved Lotemax (Loteprednol Etabonate gel )0.5% for the treatment of pain and post operation inflammation after ocular surgery.