The US Food and Drug Administration (FDA) recently announced the approval of Kala Pharmaceuticals’ Eysuvis, a topical steroid (0.25% loteprednol etabonate ophthalmic suspension), for short-term treatment of the signs and symptoms of dry eye syndrome (DES). In order to smoothen market access for this new therapy and facilitate its uptake, Kala Pharmaceuticals will need to focus on educating ophthalmologists and choose a favorable price point, says GlobalData, a leading data and analytics company.

According to GlobalData, the drug sales in the DES market is expected to grow at a compound annual growth rate (CAGR) of 10.6% from 2018 to 2028 to reach a value of $10.7bn in 2028. A significant driver of this market is an anticipated increase in the global aging population.

Vinie Varkey, MSc, Senior Pharma Analyst at GlobalData, comments: “Off-label use of corticosteroids for short-term use is fairly common among DES patients. Therefore, the approval of Eysuvis will definitely boost the confidence of this treatment modality among ophthalmologists. However, while approval of Eysuvis is positive news for an indication that has historically witnessed few new product launches or innovative therapy options, Kala can anticipate some challenges.

“Positioning of Eysuvis to target patients experiencing flare-up episodes of DES may pose a tangible challenge to Kala. Key opinion leaders interviewed by GlobalData have indicated that this model of dry eye may be an area that some ophthalmologists may not be familiar with as something that requires short-term treatment option as opposed to a chronic treatment setting. Educating ophthalmologists on this aspect of Eysuvis is likely to increase awareness and bridge this gap.”

The other formidable challenge likely to be faced by Eysuvis is from corticosteroids that are currently used as off-label options, some of which have the same active ingredient as Eysuvis, that is, loteprednol etabonate. For example, Lotemax is a topical steroid used for DES and has the same active molecule as Eysuvis but differs in concentration – Lotemax is 0.5% loteprednol etabonate.

Varkey continues: “Ophthalmologists are likely to favor cheaper versions of the molecule that are available as off-label options compared to branded versions. Kala will be doing itself and Eysuvis a favor if it can raise awareness among ophthalmologists of the difference between Eysuvis and other loteprednol-based molecules that are being used as off-label options. Additionally, the price point of Eysuvis will be a critical factor that will determine its penetration into the wider market versus off-label corticosteroid options.

“In addition to the need to establish a favorable safety and efficacy profile is the dire need for therapies to be cost-effective options; this is especially important for DES, as it is a chronic condition with no curative treatment options currently available. Having a therapy that is cost-effective increases the chances it will experience higher market penetration once it launches.”