What happened
Glaukos (GKOS 2.17%), a specialty healthcare company that concentrates on eye disorders, enjoyed a very healthy pop in its share price on Wednesday. This followed the company's latest clinical update. Investors traded the stock up by almost 19%.
So what
That update was about iDose TR, a drug aimed at treating intraocular pressure in ocular hypertension.
In a complementary pair of phase 3 trials, iDose TR achieved its primary efficacy endpoints through a three-month treatment cycle. The drug also demonstrated a favorable safety profile and was extremely well tolerated, Glaukos said.
With these results in hand, the company said, it plans to file a New Drug Application with the Food and Drug Administration for the slow-release iDose TR. It said it expects the regulator to complete its review and render a decision by the end of next year.
In its press release announcing these results, Glaukos quoted CEO Thomas Burns as saying that they "mark a major milestone for our company and powerfully reaffirms our view that iDose TR can be a transformative novel technology able to fundamentally improve the glaucoma treatment paradigm for patients."
Burns added that there remains an "unmet clinical need" for safe and effective alternatives to traditional topical solutions. iDose TR is a dropless treatment.
Now what
As any biotech investor can attest, companies like Glaukos rise and fall on the success (or lack of it) in their clinical trials. Happily for this company, the latest rounds appear to have gone smoothly and confirmed the efficacy and potential of iDose TR. It's little wonder, then, that investors reacted so positively to the news.
