Glaukos Corporation ( GKOS Quick Quote GKOS - Free Report) is focused on the development and commercialization of novel surgical devices and sustained pharmaceutical therapies designed to treat glaucoma. The strength in the iStent product line and solid execution across its global glaucoma and Corneal Health franchises augur well. The sustained recovery trends across segments and solid business prospects in spite of the pandemic-induced uncertainties raise optimism. Recent strategic alliances instill confidence in the stock.
The company is also engaged in boosting its portfolio through the development of new products. The company currently has 13 publicly-disclosed programs and another 10 yet-to-be-disclosed development programs underway. A number of these pipeline programs are in active pivotal clinical trials, including iStent infinite and iDose TR.
However, stiff competition in the medical device industry and vendor uncertainty are other headwinds. Meanwhile, a stringent regulatory approval process for the iDose platform and products is a woe.
Clinical trials are the primary means to evaluate the efficacy and safety of new medical technologies.
In January, Glaukos announced that its iDose TR sustained-release travoprost implant continued to deliver sustained substantial reductions in intraocular pressure (IOP) in a 36-month analysis in a phase IIb clinical trial conducted under a U.S. Investigational New Drug (IND) protocol.
In the same month, the company announced that it has enrolled the first patient in a phase II clinical trial of GLK-302 for the treatment of presbyopia and the first patient into a phase II clinical trial of GLK-301 for the treatment of signs and symptoms of Dry Eye Disease (DED).
In March, the company announced the commencement of the phase II clinical program for its third-generation iLink therapy designed to treat keratoconus. Glaukos, on its fiscal third-quarter earnings call, confirmed that it is on track to advance its pipeline following the recent clearances of iAccess and iPRIME, while the FDA 510(K) review of iStent infinite is ongoing as GKOS remains focused on a potential FDA clearance for this important product in the second half of 2022. These developments raise our optimism about the stock.
In September 2021, Glaukos inked a licensing agreement with Attillaps Holdings, Inc., wherein Glaukos obtained the exclusive global right to research, develop, manufacture and commercialize products, utilizing certain acetylcholinesterase inhibitors for the treatment of ophthalmic diseases caused by Demodex mites. Glaukos entered into a new development and commercialization license agreement with Santen Pharmaceutical in May for the PRESERFLO MicroShunt.
In April, Glaukos entered into an amended licensing agreement with Intratus. Per the agreement, the latter granted Glaukos a global exclusive license to research, develop, manufacture and commercialize its patented, non-invasive drug delivery platform (the Eyelid Drug Delivery Platform) for application in the treatment of presbyopia.
Factor Hurting the Stock
Glaukos’ competitors include medical companies, academic and research institutions, and others that develop new drugs, therapies, medical devices or surgical procedures to treat glaucoma. Thus, intense competition continues to weigh on the company’s overall performance.
Glaukos competes with companies like
Johnson & Johnson ( JNJ Quick Quote JNJ - Free Report) (through its acquisition of Abbott Medical Optics Inc.), STAAR Surgical Company ( STAA Quick Quote STAA - Free Report) and Iridex Corporation ( IRIX Quick Quote IRIX - Free Report) .
Johnson & Johnson has a diverse portfolio of branded drugs as well as it also sells various medical devices. JNJ’s medical device unit has four divisions — Surgery, Orthopedics, Vision and Interventional solutions.
STAAR Surgical develops and sells implantable lenses for the eye and companion delivery systems used to deliver the lenses into the eye. During the first half of fiscal 2022, STAA’s revenues grew 27.6% on the back of strong demand for its products.
Iridex is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures used to treat sight-threatening eye conditions, including glaucoma and retinal diseases. STAA has a varied product line, including laser consoles for treating glaucoma, medical retina and surgical retina.