FDA Approves iDose TR (travoprost intracameral implant) for the Treatment of Glaucoma

Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, announced   the U.S. Food and Drug Administration (FDA) approval of its New Drug Application (NDA) for a single administration per eye of iDose® TR (travoprost intracameral implant) 75 mcg, a prostaglandin analog indicated for the reduction of intraocular pressure (IOP) in patients with ocular hypertension (OHT) or open-angle glaucoma (OAG).

“With the next generation of procedural pharmaceutical solutions for glaucoma such as iDose TR, we now have a new tool that will confront the standard legacy practice of relying on topical drops, which are known to cause uncomfortable side effects and present a myriad of challenges such as treatment adherence, complex dosing regimens, and difficulty with self-administration,” said John Berdahl, MD, clinician and researcher at Vance Thompson Vision. “The clinical data suggest that iDoseTR is not only effective with a favorable safety profile, but it has potential to relieve patients from the burdens of prescription eye drops for an extended period of time. I look forward to adding this novel therapy into my treatment toolbox for the benefit of my patients.”

The 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. The FDA approval and Phase 3 data referenced below is for the slow-release iDose TR model, consistent with the company’s NDA submission and commercialization plans.

Both Phase 3 trials successfully achieved the pre-specified primary efficacy endpoints through 3 months and demonstrated a favorable tolerability and safety profile through 12 months. IOP reductions from baseline over the first 3 months were 6.6-8.4 mmHg in the iDose TR arm, versus 6.5-7.7 mmHg in the timolol control arm (mmHg range represents IOP reduction means across the six U.S. FDA pre-specified timepoints of 8 a.m. and 10 a.m. at Day 10, Week 6 and Month 3). Based on these outcomes, the FDA concluded in the prescribing information that iDose TR demonstrated non-inferiority to timolol ophthalmic solution in IOP reduction during the first 3 months. The FDA also noted that subsequently iDose TR did not demonstrate non-inferiority over the next 9 months.

iDose TR is a first-of-its-kind, long-duration, intracameral procedural pharmaceutical therapy designed to continuously deliver 24/7 therapeutic levels of a proprietary formulation of travoprost inside the eye for extended periods of time. iDose TR is intended to improve the standard of care by addressing the ubiquitous patient non-compliance issues and chronic side effects associated with topical glaucoma medications.

“The FDA approval of iDose TR represents a significant milestone for Glaukos following an extensive pioneering journey since the inception of the original idea nearly 15 years ago. Today’s approval ushers in a new era of interventional glaucoma therapy by enabling a more proactive and reliable approach for patients in need,” said Thomas Burns, Glaukos chairman and chief executive officer. “We believe iDose TR can be a transformative, novel technology able to fundamentally improve the treatment paradigm for patients with open-angle glaucoma or ocular hypertension. We are grateful to the clinical investigators and study participants in the clinical trials for their instrumental roles in helping us reach this important advancement for glaucoma patient care. At Glaukos, we are relentlessly focused on delivering novel therapies for chronic eye diseases and now iDoseTR has the potential to redefine the standard of care for patients in the U.S. affected by open-angle glaucoma and ocular hypertension.”

Ref : https://en.wikipedia.org/wiki/Travoprost

FDA Approves iDose TR (travoprost intracameral implant) for the Treatment of Glaucoma

Most Commonly Used Glaucoma Drug Can Cause Droopy Eyelids | Massachusetts Eye and Ear Infirmary

Prostaglandin analogues (PGAs), drugs which lower intraocular pressure, are often the first line of treatment for people with glaucoma, but their use is not without risks. PGAs have long been associated with blurred vision, dryness, changes in eye color and other side effects. Now a new study has found that these drugs also cause upper and lower eyelid drooping and other issues that can interfere with vision.

"We identified important side effects of PGAs, namely the loss of periorbital fat in the upper and lower lid and the presence of ptosis," said senior author Louis R. Pasquale, M.D., F.A.R.V.O., director of the Glaucoma Service at Mass. Eye and Ear and associate professor of ophthalmology at Harvard Medical School. "The loss of periorbital fat was previously described by us in a small series of unilateral PGA users. In fact, those observations did ultimately lead to a change in drug labeling. These new findings could change labeling for the PGAs, as the upper lid ptosis could aggravate pre-existing visual field loss."

Researchers performed this study to confirm whether prostaglandin-associated periorbitopathy (PAP) is clearly associated with PGA application among bilateral users using a validated grading scheme applied by masked observers and confirmed by clinical examination. They performed multivariable analyses to assess whether PAP was independently associated with PGA use or if it was the result of confounding features such as age, ethnicity, BMI or use of other classes of glaucoma medications. They studied 343 patients (186 females and 157 males) over the course of seven months in 2011.

The study showed associations between current bilateral PGA use and deepened upper eyelid sulci, hollowing of the inferior periorbital fat pads, upper eyelid ptosis with levator muscle dysfunction, and lower lid retraction. Their work demonstrated that PAP is fairly common and consists of findings that extend beyond deepening of the upper eyelid sulcus.

Most Commonly Used Glaucoma Drug Can Cause Droopy Eyelids | Massachusetts Eye and Ear Infirmary

Ref : http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0061638