Eyeworld

MAY 2019 | SUPPLEMENT TO EYEWORLD | 9 illustrates that it is as effective as branded prednisolone in a postoperative cataract study." 1 MPP technology Meanwhile, there is exciting new technology, under review by the U.S. FDA, for treat- ment of dry eye. This inves- tigational product (KPI-121 0.25% ophthalmic suspension, Kala Pharmaceuticals) uses loteprednol etabonate, but in a unique way. It uses mucus- penetrating nanoparticles (MPP) to enhance delivery to target tissues of the eye, which allows for better and even distribution of the corti- costeroid. 2 MPPs allows for better penetration of the corticoste- roid through mucus, which acts as a natural barrier in the tear film and works to prevent penetration of foreign parti- cles, pathogens, etc., including topical therapeutics. "The aim has been to find a way to allow for better penetration," said Elizabeth Yeu, MD. "If we could find a way to achieve better penetration, it would potentially lead to better efficacy with the medication," she said. "We already know Five out of six respondents agree that a different therapeutic strategy is required for patients who have chronic dry eye disease versus patients experiencing dry eye flares. Is there any difference in your therapeutic strategy for patients who have chronic dry eye disease versus patients experiencing dry eye flares? No 17% Yes 83% loteprednol is extremely effec- tive as a steroid, so by being embedded within nanopar- ticles the corticosteroid can effectively penetrate through the mucus pores, thus poten- tially increasing its therapeutic effects." Dr. Gupta pointed out that loteprednol is a familiar and trusted therapeutic within the ophthalmic community, and this new nanoparticle vehicle enables this traditional drug to be just as safe but more effective. 3 Terry Kim, MD, sees the use of mucus-penetrating nanoparticles as an exciting development. "The MPP technology allows the drug to get through the mucin layers of the tear film and ocular surface to penetrate better and evenly," Dr. Kim said. "We see breakthrough flares, despite patients being on maintenance therapy, so it makes sense that what we need in terms of the treatment gap is a corticoste- roid that is not only effective but also safe, and in the Phase 2 and both STRIDE trials it was very effective in terms of meeting the primary endpoint of reduction in conjunctival hyperemia. Equally important, the IOP elevation profile is excellent with this molecule." Dr. Gupta suggested that this technology would benefit a dry eye flare management plan. "It will be something that patients will be able to use for a limited, short-term, 1- to 2-week period, on a one drop BID basis, and I think patients will be very receptive to this because they are look- ing for fast relief," she said. Dr. Holland said, "Dry eye patients have often been to multiple eyecare providers and they want something to manage their symptoms right away. No matter what main- tenance therapy we're consid- ering, I'd like to immediately relieve their symptoms with a safe and effective topical ste- roid, then talk about using it periodically for dry eye flares as well." Dr. Lindstrom pointed out that corticosteroids have long been used off-label for these indications, but he sug- gested that eyecare providers would much prefer having a formulation approved and la- beled for dye eye treatment. n References 1. Lane SS, Holland EJ. Loteprednol etabonate 0.5% versus prednisolone acetate 1.0% for the treatment of inflammation after cataract surgery. J Cataract Refract Surg. 2013;39: 168–73. 2. Schopf L, et al. Ocular pharmacoki- netics of a novel loteprednol etabonate 0.4% ophthalmic formulation. Ophthal- mol Ther. 2014;3:63–72. 3. Kim T, et al. Safety and efficacy of twice daily administration of KPI-121 1% for ocular inflammation and pain following cataract surgery. Clin Oph- thalmol. 2018;13:69–86.

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