Glaukos Lowers Q3, FY17 Sales Guidance Below Street

Glaukos (GKOS) said Thursday it is lowering its sales guidance for Q3 and full year 2017, below Street estimates during its Investor Day Presentation.

The ophthalmic medical technology company said that it now expects Q3 sales of $38 million-$40 million, from the prior guidance range of $41 million-$43 million. Analysts on Capital IQ are expecting sales of $42.6 million.

For FY17, it sees net sales of $155 million-$160 million, versus the Street view of $165.9 million. The prior guidance range was for $162 million-$167 million.

The company said the revised guidance reflects its current assessment of certain transitory impacts to iStent procedure volumes, including commercial carrier reimbursement, recent hurricanes, and reimbursement changes in Australia, together with less transitory factors, including new MIGS competition entering the market.

Glaukos will also announce plans to pursue U.S. FDA approval of iStent infinite, a three-stent trabecular bypass standalone solution for refractory open-angle glaucoma patients. In Q4, the company expects to submit an Investigational Device Evaluation filing with the FDA, with plans to conduct a one-year clinical study of approximately 65 subjects, followed by a 510(k) submission.

The company will also report preliminary efficacy and safety results from the U.S. Investigational New Drug phase II clinical trial to evaluate the reduction of intraocular pressure by its Travoprost Intraocular Implant with the iDose delivery system in patients with open-angle glaucoma.

Preliminary results showed that both models of the iDose Travoprost are currently achieving an approximate 8 mm Hg reduction in mean intraocular pressure in the cohort of patients followed through nine months postoperative. In addition, the preliminary study results showed a favorable safety profile for iDose Travoprost, with no incidents of hyperemia reported.

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