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Medtech Co. Meets Primary Endpoints in Ph. 3 Glaucoma Trials
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Glaukos Corp.'s shares traded 18% higher yesterday after the company reported that in two separate Phase 3 trials, its iDose TR met its primary efficacy endpoints by lowering intraocular pressure in glaucoma patients.

Ophthalmic medtech and pharmaceutical company Glaukos Corp. (GKOS:NYSE), which is focused on the development of new therapies for use in treating glaucoma, corneal disorders, and retinal diseases, yesterday announced "positive topline data for both Phase 3 pivotal trials of iDose TR that successfully achieved its pre-specified primary efficacy endpoints through three months in both Phase 3 trials and demonstrated excellent tolerability and a favorable safety profile through 12 months."

Glaukos reported that following three months of treatment in the iDose TR Phase 3 pivotal trials, both the fast- and slow-release arms successfully met the primary efficacy endpoint, which was identified as "non-inferiority to the active comparator arm (twice-daily topical timolol ophthalmic solution, 0.5%) through three months."

The firm advised that in the Ph. 3 GC-010 study's slow-release iDose TR arm, intraocular pressure (IOP) decreased by 6.6-8.5 mmHg from baseline, compared to a reduction of 6.6-7.7 mmHg in the timolol control arm. Similar results were reported in the Ph. 3 GC-012 trial, where IOP decreased by 6.7-8.4 mmHg in the slow-release iDose TR arm versus a reduction of 6.8-7.2 mmHg recorded in the timolol control arm.

The company pointed out that "93% of slow-release iDose TR subjects remained well-controlled on the same or fewer IOP-lowering topical medications at 12 months compared to screening after a single administration of iDose TR, versus 67% of timolol control subjects in both Phase 3 trials, and in addition, 81% of slow-release iDose TR subjects were completely free of IOP-lowering topical medications at 12 months across both trials."

The firm noted that in both studies, the iDose TR produced consistent outcomes across multiple sites and demonstrated effective and convenient in-office administration.

Glaukos Corp.'s Chairman and CEO Thomas Burns stated, "We are very pleased to announce these robust and replicative positive Phase 3 pivotal data results for iDose TR, which 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 … We believe there is an important unmet clinical need and strong appetite within the ophthalmic community for safe, effective and sustained dropless pharmaceutical alternatives to traditional topical medications. These data leave us ideally positioned for an upcoming NDA submission and FDA review for iDose TR as we continue to advance our mission to transform vision for the benefit of patients around the globe suffering from chronic eye diseases."

The company advised that based upon the results achieved in the two Phase 3 studies, it plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the slow-release iDose TR model. The firm indicated that it anticipates that the FDA will complete its review and issue a decision by the end of CY/23.

The company explained that the iDose TR is administered during a micro-invasive procedure. The iDose TR contains a formulation of travoprost, which is a prostaglandin analog drug utilized to reduce IOP. After the travoprost medication has been time-released, the iDose TR can be removed and replaced with a new iDose TR system, thus providing patients with an alternative to daily eye drop treatments with pressure-reducing drops such as Timolol.

The company noted that the two Phase 3 studies were designed similarly with the same primary objectives except for the timing of medication release (slow vs. fast). In total, the trials enrolled and randomized 1,150 subjects at 89 clinical sites. The firm indicated that about 67% of slow-release iDose TR subjects enrolled in the studies had currently been taking at least one IOP-lowering medication.

In the GC-010 trial, 590 subject participants were split into three roughly equal groups into either a slow-release or fast-release iDose TR arm or a timolol active comparator arm. Similarly, 560 patients in the GC-012 study were separated into equal groups and were randomized to receive one of the three treatment options.

In a separate news release yesterday, Glaukos Corp. announced that it had achieved a major milestone reporting that "its iStent® family of technologies has now been implanted in more than one million procedures worldwide."

The company commented that reaching this level of acceptance by the market is a testament to its decades-long history of investment in the micro-invasive glaucoma surgery (MIGS) space.

Ike Ahmed M.D., Professor, Dept. of Ophthalmology and Visual Sciences at Utah's John A. Moran Eye Center and Chief Innovation Officer at Prism Eye Institute in Toronto, commented, "One million iStents implanted is a tremendous accomplishment, and I'm grateful to Glaukos for their continued dedication, investment, and pioneering spirit to advance the development of innovative glaucoma technologies designed to improve the treatment paradigm for the benefit of patients worldwide."

"As one of the early adopters, I have experienced first-hand how iStent, as the first MIGS device, and subsequent generations have fundamentally revolutionized the way we think and treat glaucoma over the last decade," Dr. Ahmed added.

John Berdahl, M.D. of Vance Thompson Vision in South Dakota, stated, "iStent technologies have allowed me to change the way I treat my patients for the better…iStent inject W is my most commonly used surgical option for glaucoma patients undergoing cataract surgery. We now have patient data out past 9 years in my practice showing the iStent is still effective and safe at lowering IOP and reducing medications."

CEO Burns remarked, "I am proud of this tremendous achievement for our company and the MIGS marketplace, reflecting decades of investment and successful advancement of our strategic vision to transform the treatment of chronic, debilitating eye diseases through the development of novel, sustainable therapies."

Glaukos is an ophthalmic-focused medical technology and pharmaceutical firm based in Aliso Viejo, Calif. The company is working to develop and commercialize novel therapies for use in treating glaucoma, retinal diseases, and corneal disorders.

The company indicated that "it first developed Micro-Invasive Glaucoma Surgery (MIGS) as an alternative to the traditional glaucoma treatment paradigm." The company advised that "its iStent inject W Trabecular Micro-Bypass System Model G2-W is indicated for use in the U.S. in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma."

Glaukos Corp. started off yesterday with a market cap of around $2.29 billion, with approximately 47.6 million shares outstanding and a short interest of about 3.5%. GKOS shares opened yesterday nearly 10% higher at $52.76 (+$4.66, +9.69%) over the previous day's $48.10 closing price. The stock traded yesterday between $51.49 and $60.92 per share and closed for trading at $57.01 (+$8.91, +18.52%). It is currently trading at $58.27.

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