Since its founding in 2001, the Glaukos core objective has been to transform glaucoma therapy. Today, Glaukos still is dedicated exclusively to treating glaucoma, the leading cause of permanent blindness worldwide.¹

In the evolution of ophthalmic procedures, certain developments — for example, phacoemulsification in cataract surgery, laser correction for refractive error, and anti-VEGF injections for diabetic retinopathy — have produced a fundamental change in treatment paradigms and prognoses for certain diseases.

In the treatment of glaucoma, the approach to surgical interventions has been altered substantially by the introduction of minimally invasive glaucoma surgery (MIGS) technology. MIGS procedures have filled a key gap in glaucoma management, providing an intermediate surgical option between topical medication and traditional filtering surgery. Glaukos was the only company with an FDA-approved MIGS device (the iStent) for many years, and still plays an active role in developing advanced glaucoma technologies.

FULL SPECTRUM

Building upon expertise in micro-scale technology, the company’s overarching goal is to introduce treatments for the full spectrum of glaucoma, from ocular hypertension to refractory disease. Glaukos accomplishes this by designing devices to be used in stand-alone procedures or in combination with each other.

ROBUST RESEARCH

Each product, rather than being a top-down directive, acts as a catalyst for a robust research program. Indeed, for a company of its size, Glaukos has a surprisingly large number of clinical studies and publications — more than 45 total international and domestic trials, including more than 20 ongoing studies and five major FDA trials, and more than 55 peer-reviewed publications, which incorporate Glaukos-affiliated studies and personal data from surgeons.

The value of this research is twofold. First, it provides important information on the performance of the company’s marketed and pipeline products. Second, it does so across a spectrum of glaucoma severities. The iStent trabecular micro-bypass stent, Glaukos’ first and signature device, has been evaluated in subjects with mild to moderate glaucoma in several Glaukos studies, including the pivotal FDA trial,² GCF-017,³ GCF-033⁴; and in numerous surgeons’ independent reports.^5-8 Meanwhile, Glaukos study GCF-022 evaluates the iStent in newly-diagnosed glaucoma;⁹ and study GCF-018¹⁰ and the cohort of Gallardo and colleagues¹¹ examined the iStent in more moderate to severe stages of glaucoma.

Other Glaukos devices have similarly aggressive research profiles. For example, the second-generation trabecular micro-bypass stent, iStent inject, has been studied in subjects with glaucoma ranging from mild to more advanced disease.^12-15 The iStent Supra suprachoroidal stent, designed to be a second-line or adjunctive procedure to trabecular stent(s), is being investigated in at least five ongoing Glaukos studies, including a pivotal FDA trial (GC-007). Finally, the iDose travoprost intraocular implant, targeting ocular hypertension and mild to moderate glaucoma, is being evaluated in another pivotal FDA trial (GC-009).

Glaukos is the corporate founder of micro-invasive glaucoma surgery, so it comes as no surprise that Glaukos has a strong commitment to research and clinical studies. The volume and diversity of its research demonstrate the company’s longstanding commitment to glaucoma — both in terms of advancing new treatments as well as improving the lives of patients with the disease. GP

References

1. Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014;121(11):2081-2090.
2. Samuelson TW, Katz LJ, Wells JM, Duh YJ, Giamporcaro J; US iStent Study Group. Randomized evaluation of the trabecular micro-bypass stent with phacoemulsification in patients with glaucoma and cataract. Ophthalmology. 2011;118(3):459-467.
3. Donnenfeld ED, Solomon KD, Voskanyan L, Chang DF, Samuelson TW, Ahmed II6, et al. A prospective 3-year follow-up trial of implantation of two trabecular microbypass stents in open-angle glaucoma. Clin Ophthalmol. 2015;9:2057-2065.
4. Katz LJ, Erb C, Carceller Guillamet AC, et al. Prospective, randomized study of one, two, or three trabecular bypass stents in open-angle glaucoma subjects on topical hypotensive medication. Clin Ophthalmol. 2015;9:2313-2320.
5. Neuhann TH. Trabecular micro-bypass stent implantation during small-incision cataract surgery for open-angle glaucoma or ocular hypertension: Long-term results. J Cataract Refract Surg. 2015; 41:2664-2671.
6. Fea AM. Phacoemulsification versus phacoemulsification with micro-bypass stent implantation in primary open-angle glaucoma. J Cataract Refract Surg. 2010;36:407-412.
7. Arriola-Villalobos P, Martinez-de-la-Casa J, Diaz-Valle D, et al. Combined iStent trabecular micro-bypass stent implantation and phacoemulsification for coexistent open-angle glaucoma and cataract: a long-term study. Br J Ophthalmol. 2012;96(5):645-649.
8. Ferguson TJ, Berdahl JP, Schweitzer JA, Sudhagoni RG. Clinical evaluation of a trabecular micro-bypass stent with phacoemulsification in patients with open-angle glaucoma and cataract. Clin Ophthal. 2016;10:1767-1773.
9. Vold SD, Voskanyan L, Tetz M, et al. Newly diagnosed primary open-angle glaucoma randomized to 2 trabecular bypass stents or prostaglandin: outcomes through 36 months. Ophthalmol Ther. 2016;5(2):161-172.
10. Ahmed II, Katz LJ, Chang DF, Donnenfeld ED, Solomon KD, Voskanyan L, et al. Prospective evaluation of microinvasive glaucoma surgery with trabecular microbypass stents and prostaglandin in open-angle glaucoma. J Cataract Refract Surg. 2014;40(8):1295–300.
11. Gallardo M, Supnet R, Giamporcaro JE, Hornbeak DM. Outcomes of combined trabecular micro-bypass and phacoemulsification in a predominantly Hispanic patient population. Clin Ophthalmol. 2016;10:1931-1937.
12. Arriola-Villalobos P, Martínez-de-la-Casa JM, Díaz-Valle D, García-Vidal SE, Fernández-Pérez C, García-Sánchez J, et al. Mid-term evaluation of the new Glaukos iStent with phacoemulsification in coexistent open-angle glaucoma or ocular hypertension and cataract. Br J Ophthalmol. 2013;97:1250-1255.
13. Fea AM, Belda JI, Rękas M, Jünemann A, Chang L, Pablo L, et all. Prospective unmasked randomized evaluation of the iStent inject versus two ocular hypotensive agents in patients with primary open-angle glaucoma. Clin Ophthalmol. 2014;8:875-882.
14. Voskanyan L, García-Feijoó J, Belda J, Fea A, Jünemann A, Baudouin C. Prospective, unmasked evaluation of the iStent inject system for open-angle glaucoma: synergy trial. Adv Ther. 2014;31(2):189-201.
15. Lindstrom R, Lewis R, Hornbeak DM, Voskanyan L, Giamporcaro JE, Hovanesian J, Sarkisian S. Outcomes following implantation of two second-generation trabecular micro-bypass stents in patients with open-angle glaucoma on one medication: 18-month follow-up. Adv Ther. 2016;33(11):2082-2090.