On the horizon
Kala Pharmaceuticals has submitted a new drug application to the U.S. Food and Drug Administration (FDA) for KPI-121 (0.25%) for the treatment of dry eye based on the strength of one phase 2 trial and two phase 3 trials, STRIDE 1 and STRIDE 2.
The trials enrolled almost 2,000 patients, and indicated statistical significance for the primary endpoint of conjunctival hyperemia, as well as the primary symptom endpoint of ocular discomfort severity.
If approved, KPI-121 would be first product indicated for the temporary relief of the signs and symptoms of dry eye disease and flares. The agent uses Kala’s AMPPLIFY drug delivery technology to better penetrate the target tissues.
Data from the phase 3 clinical trial, STRIDE 3 (ClinicalTrials.gov Identifier: NCT03616899), is expected to be released later this year.
In the pipeline
Aldeyra Therapeutics is now enrolling patients into the RENEW phase 3 clinical trial, which will evaluate the efficacy of reproxalap ophthalmic solution (0.25%) versus vehicle in 400 patients with moderate and severe DED.
Co-primary endpoints are ocular dryness and fluorescein nasal region ocular staining (ClinicalTrials.gov Identifier: NCT03879863).
The phase 3 trial comes on the heels of successful phase 2b trial results, which demonstrated statistical superiority of reproxalap versus vehicle across multiple dry eye signs and symptoms.
In the new study, patients will be randomly assigned to one of four arms: reproxalap 0.25% administered QID for 12 weeks; reproxalap 0.25% administered QID for four weeks, then BID for eight weeks, or vehicle comparators to each of the active arms. Targeted trial completion is April 2021.
Aurinia Pharmaceuticals recently announced phase 2 data of its 100-person, double-masked, head-to-head trial comparing voclosporin ophthalmic solution (VOS) to Restasis. Both drugs were well-tolerated and there was no statistical difference between VOS and Restasis for the primary endpoint; both drugs exhibited low drop-discomfort scores.
VOS did show statistically significant improvements over Restasis at week 4 for objective tests, including Schirmer’s and fluorescein corneal staining.
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