Glaukos Wins FDA Nod for Glaucoma Treatment Implant

In case you missed it, Glaukos, a prominent player in the Microinvasive Glaucoma Surgery (MIGS) space completed a 15-year regulatory journey.

The San Clemente, CA-based company won a nod from FDA for the iDose travoprost intracameral (TR) implant, indicated for use in patients with primary open-angle glaucoma (OAG) or ocular hypertension.

“It’s really a novel product,” Cody McKenzie, VP, Franchise Head - Glaucoma at Glaukos, told MD+DI. “It’s a first of kind here as we think about the glaucoma landscape. It took over a hundred-thousand-page submission to get this approved because again we had to meet all of the different device and drug regulations. The indication for the product is quite open. In fact, what we did was follow the 505(b)(2) pathway, which essentially lets you take an existing therapy and you don’t have to prove the molecule itself. The path to market took us about 15 years but the indication for the product is exactly the same as a topical medication. It’s broad and it will enable broad patient access.”

FDA approval is based on results from two prospective, randomized, multicenter, double-masked, Phase 3 pivotal trials (GC-010 and GC-012) designed to compare the safety and efficacy of a single administration of one of two iDose TR models with different travoprost release rates (referred to as the fast- and slow-release iDose TR models, respectively) to topical timolol ophthalmic solution, 0.5% BID (twice a day), in reducing IOP in subjects with open-angle glaucoma or ocular hypertension. In total, the Phase 3 trials randomized 1,150 subjects across 89 clinical sites.

Related:7 Moments that Defined the MIGS Market

John Berdahl, MD, an ophthalmologist in Sioux Falls, SD told MD+DI, “By putting microdosages in the eye and only delivering the drug to where its mechanism of action works and not where the side effects occur - provides a huge opportunity and advantage for patients to help them prevent progression of the second leading cause of blindness in the world.”

Now that approval is out of the way the company has to contend with reimbursement. BTIG analyst, Ryan Zimmerman pointed out the what the reimbursement landscape would look like for the company.  

“Glaukos will need to establish reimbursement for iDose with a J-Code,” Zimmerman wrote in a research note. “Given there are four application deadlines per year to establish a J-Code, we think it’s likely Glaukos would target a July 1, 2024, or Oct. 1, 2024, which sets up submission on the first business date on either March or June 2024. Glaukos will need to provide a number of pieces of information for its application (dosage, labeling, usage, administration method, etc.). Most importantly Glaukos will provide a copy of the most recent average wholesale price or wholesale acquisition cost along with the average sales price.”

He noted that companies in the MIGS space would have to also contend with Palmetto GBA announcement of the implementation of its MIGS LCDs would not become final on January 29th as previously expected.

“This leaves us with several questions around the finality of the decision; will the LCD be removed or has the MAC once again changed its thinking on MIGS coverage,” Zimmerman wrote.  “Will the other MACs follow suit and remove the current LCDs before they are to be implemented? What is the potential impact for Glaukos? We walk through our thoughts on these questions below, but in short, ultimately believe that if the MACs walk back their changes to MIGS coverage, Glaukos iDose trajectory wouldn't be impacted but upside to numbers in the stent business would be hampered by the loss of competitive share gains.”