GKOS Stock Rises on Positive Phase 3 Confirmatory Trial for Epioxa
Glaukos Corporation GKOS recently announced that the second Phase 3 confirmatory pivotal trial for Epioxa, the company’s next-generation corneal cross-linking iLink therapy for the treatment of keratoconus, successfully met the study’s pre-specified primary efficacy endpoint. The results demonstrated a clinically relevant and statistically significant improvement in maximum corneal curvature (Kmax) at 12 months from baseline between the Epioxa treated arm and the sham/placebo-controlled arm.
Kmax is a FDA-approved primary efficacy outcome for keratoconus pivotal trials and an objective measurement of the steepest corneal curvature based on corneal topography, where an increasing Kmax denotes corneal steepening and keratoconus disease progression.
Likely Trend of GKOS Stock Following the News
Following the announcement, shares of the company moved north 0.5% and closed at $128.20 on Wednesday.
For the year-to-date period, GKOS shares have rallied 61.3% compared with the industry’s rise of 6.2%. The S&P 500 increased 22.5% in the same time frame.
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More on GKOS’s Epioxa
Keratoconus is a severe eye condition that is typically identified in adolescence and is characterized by progressive corneal thinning and weakness. Keratoconus is one of the main reasons for corneal transplants performed in the United States. If this condition is left untreated, it can lead to loss of vision.
GKOS’s Epioxa, which is designed to preserve the corneal epithelium, reduce procedure times, improve patient comfort and shorten recovery time, utilizes a proprietary, novel drug formulation designed to penetrate the epithelial layer of the cornea, a stronger UV-A irradiation protocol and the ability to deliver increased levels of supplemental oxygen to enhance cross-linking.
Glaukos recently completed a successful clinical pre-NDA meeting with the FDA regarding Epioxa as a novel treatment for keratoconus. The purpose of the meeting was to obtain agreement from the FDA on the content of the proposed NDA, and in particular, to confirm that the company’s clinical data package, including the two completed Phase 3 pivotal studies, would be sufficient to support an NDA submission and review. As an outcome of this pre-NDA meeting, the FDA agreed that the proposed clinical data package is sufficient to support an NDA submission and review.
More on Epioxa’s Study Data
The multi-center, randomized, placebo and sham-controlled Phase 3 confirmatory pivotal trial randomized 312 eyes and was designed to evaluate the safety and efficacy of Glaukos’ Epioxa therapy in impeding the progression of, and/or reducing Kmax, in eyes with progressive keratoconus. The study eyes were randomized in a 2:1 ratio to receive Epioxa therapy or placebo and sham procedure control treatment.
The study’s primary efficacy endpoint was the mean change in Kmax from baseline to Month 12. Based on a special protocol assessment agreement with the FDA, the study was considered a success if the difference between the treatment and control arm in the primary efficacy endpoint is statistically significant and the difference is ≥ 1.0 D.
Per the topline summary results and observations from the Phase 3 confirmatory pivotal trial, the trial successfully achieved its primary efficacy outcome. With 91.5% of enrolled treatment patients finishing the 12-month trial compared with 90.9% of enrolled control patients, the treatment was generally well-tolerated. No significant adverse events involving the eyes were documented, and no patients randomized to receive Epioxa medication had to stop treatment early because of an adverse event.
Most adverse events that were documented were of a moderate and temporary type. During the 12-month evaluation period, there was no change in the counts of corneal endothelial cells, nor was there any indication of systemic effects connected to the treatment, as described in the study.
GKOS’s Zacks Rank & Stocks to Consider
GKOS carries a Zacks Rank #3 (Hold) at present.
Some better-ranked stocks in the broader medical space are DaVita Inc. DVA, Baxter International Inc. BAX, and Boston Scientific Corporation BSX.
DaVita, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 17.5%. DVA’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 24.2%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
DaVita’s shares have gained 116.4% compared with the industry’s 38.3% rise in the past year.
Baxter, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 10%. BAX’s earnings surpassed estimates in each of the trailing four quarters, with the average being 3.7%.
Baxter has gained 15% compared with the industry’s 30.7% rise in the past year.
Boston Scientific, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 12.6%. BSX’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 7.2%.
Boston Scientific’s shares have rallied 74.7% compared with the industry’s 30.7% rise in the past year.
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