Glaukos plans to file for US approval of its iLink corneal cross-linking therapy Epioxa (Epi-on) for treating keratoconus after the therapy met the primary endpoint in a Phase III trial.
The study met its pre-specified primary efficacy endpoint showing a statistically significant change in maximum corneal curvature (Kmax) at 12 months compared with placebo. The California-based company noted that the primary endpoint fulfils the US FDA's efficacy criteria for keratoconus trials as it considers Kmax a key indicator of disease progression.
The company intends to file for the therapy’s approval by the end of the year. This Phase III trial, along with the first Phase III pivotal trial (NCT03442751), will form the basis of the new drug application (NDA) for Epioxa. Glaukos noted that the “proposed clinical data package is sufficient to support an NDA submission and review” as part of a pre-NDA meeting with the FDA.
The news was favourably viewed by the company’s investors. Glaukos stock was up by 1.6% in pre-market trading today. The company’s market cap currently stands at $7bn.
Epioxa is to be used during the corneal cross-linking procedure to treat keratoconus, a non-inflammatory eye disease characterised by progressive thinning and weakening of the cornea, leading to vision problems. The minimally invasive procedure uses ultraviolet light and eye drops to strengthen the collagen fibres in the cornea.
The placebo and sham-controlled Phase III trial evaluated 312 eyes with progressive keratoconus. The study achieved its primary efficacy outcome by demonstrating a Kmax treatment effect of –1.0 diopter (D). The 1.0D improvement difference between the two groups at 12 months was set as pre-defined success criteria as part of the special protocol assessment agreement with the FDA.
The Epioxa treatment was well tolerated, with no discontinuations due to treatment-emergent adverse events in the Epioxa arm. Glaukos noted that there was “no evidence of treatment-related systemic effects” and there was no change in corneal endothelial cell counts over 12 months.
Keratoconus leads to corneal thinning and can result in severe vision loss or the need for a corneal transplant if untreated. Current disease management is primarily symptomatic treatment. Another option is Glaukos' iLink therapy, Photrexa, which is approved by the FDA as part of the corneal cross-linking device to slow or halt disease progression.
Photrexa uses a cross-linking procedure, which requires the removal of the outermost layer of the cornea. Epioxa, also referred to as ‘epi-off’ crosslinking, offers an improvement on Photrexa as it does not involve the removal of the epithelium.
The corneal therapies and device segment is a growing one for Glaukos. The segment contributed 20.6% of the total sales of $95.7m in the second quarter of this year, as per the company’s financials.
