Kala’s Dry Eye Treatment Meets Primary and Secondary Endpoints in Phase 3 Trial
Darrell E. White, MD
Kala’s announcement of success with STRIDE 3, essentially replicating the positive results found in STRIDE 1 and STRIDE 2, is expected to solidify her bid for Eysuvis approval by the FDA later this year. As stated in its press release, the primary endpoint of symptom relief was met both for the overall treatment group as well as for a subgroup consisting of patients with more severe dry eye. Secondary endpoints clinically significant for us – conjunctival hyperemia and total corneal staining – also found statistically significant superiority of Eysuvis over vehicle. The study drug met safety requirements and was generally well tolerated.
Public statements from Kala leaders over the past 2 years tell us that they will proceed with their application for approval for the short-term treatment of symptoms of DED. Eysuvis is likely to have a label calling for dosing four times a day for 2 weeks. Considering the proven safety of loteprednol in general and Eysuvis in several trials, this seems reasonable. One could easily see this drug being used as part of an “induction” treatment for DED, starting a chronic care program with a prescription for Eysuvis along with an immunomodulator such as cyclosporin A or lifitegrast. While patients with chronic DED would continue to take the immunomodulator, Eysuvis could then be used to manage the inevitable acute exacerbations seen in virtually all patients with DED.
Eysuvis’s approval will give us the first topical steroid with on-label approval for the treatment of dry eye (note: Flarex [fluorometholone acetate ophthalmic suspension, Eyevance Pharmaceuticals] is approved for virtually all inflammatory entities of the ocular surface; “Dry eye” is not mentioned on its label). It should also be noted that Eysuvis is likely to receive approval to treat both the signs and symptoms of DED, previously the call sign of Xiidra (lifitegrast 5% ophthalmic solution, Novartis) alone. This will hopefully mean removing one more barrier that is holding back the wider use of steroids in the treatment of DED.
Darrell E. White, MD
Member of the board of directors of Healio / OSN
Disclosures: White reports that he is a consultant for Kala Pharmaceuticals.