FDA Approves New Drug Application for Travoprost Intracameral Implant

News
Article

Announced by Glaukos on December 14, 2023, the prostaglandin analog approval is indicated for the reduction of intraocular pressure among patients with ocular hypertension or open-angle glaucoma.

US Food and Drug Administration logo | Image Credit: FDA

Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has approved the new drug application (NDA) for a single administration of travoprost intracameral implant (iDose® TR), a long-duration prostaglandin analog indicated for intraocular pressure (IOP) reduction among patients with ocular hypertension (OHT) or open-angle glaucoma (OAG).1

Announced by Glaukos on December 14, 2023, the first-of-its-kind intracameral implant is designed to continuously deliver therapeutic levels of a proprietary formulation of travoprost inside the eye for extended durations of time. According to Glaukos, the product is intended to enhance the standard of care for patients by addressing non-compliance issues and chronic side effects associated with topical medications for glaucoma.

“With the next generation of procedural pharmaceutical solutions 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,” John Berdhal, MD, a clinician and researcher at Vance Thompson Vision, said in a statement.1

Agency approval was based on results from the prospective, randomized, multicenter, double-masked, pivotal phase 3 GC-010 and GC-012 trials.2 These trials were designed to compare the safety and efficacy of a single administration of 1 of 2 intracameral implants with slow- or fast-release rates of travoprost to topical, twice-daily timolol ophthalmic solution, 0.5% BID among a patient population with OAG or OHT.

Overall, the phase 3 trials randomized 1,150 subjects across 89 clinical sites. FDA approval and relevant phase 3 data were based on the slow release travoprost intracameral implant model, consistent with the NDA submission and commercialization plans from Glaukos. Both phase 3 trials met the pre-specified primary efficacy endpoint through 3 months, showing favorable tolerability and safety through 12 months.

Analyses showed the IOP reductions from baseline in the first 3 months were 6.6–8.4 mmHg in the travoprost intracameral implant arm, compared with 6.5–7.7 mmHg in the timolol control arm. The ranges illustrated IOP reduction means across 6 pre-specified time points of 8 am and 10 am at Day 10, Week 6, and Month 3.

Given these study results, the FDA concluded in the prescribing information that the travoprost intracameral implant exhibited non-inferiority to timolol ophthalmic solution in IOP reduction during the first 3 months.1 However, the agency noted the intracameral implant did not demonstrate non-inferiority over the following 9 months.

At month 12 of study, approximately 81% of participants in the travoprost intracameral implant arm were completely free of IOP-lowering topical medications across both phase 3 trials. Across both trials, Glaukos indicated the intracameral implant showed strong tolerability and participant retention, with 98% of participants continuing in the trial at 12 months, compared with 95% of control participants.

Safety data revealed the most common ocular adverse reactions reported in 2-6% of travoprost intracameral implant participants were rises in IOP, iritis, dry eye, and visual field defects. Glaukos noted in the release that most of these events were mild and transient.

“The clinical data suggest that iDose TR is not only effective with a favorable safety profile, but it has the potential to relieve patients from the burdens of prescription eye drops for an extended period of time,” Berdhal said.1

Glaukos noted its intent to initiate the initial commercial launch for the travoprost intracameral implant in the first quarter of 2024. According to the release, the FDA approval has marked a significant milestone for the company and marked a new era of proactive interventional glaucoma therapy

“Today’s approval ushers in a new era of interventional glaucoma therapy by enabling a more proactive and reliable approach for patients in need,” Thomas Burns, chairman and chief executive officer at Glaukos, said in a statement.1 “We believe iDose TR can be a transformative, novel technology able to fundamentally improve the treatment paradigm for patients with OAG or OHT.”

References

  1. Glaukos Announces FDA Approval of iDose®TR (travoprost intracameral implant). Glaukos. December 14, 2023. Accessed December 14, 2023.
  2. Glaukos Announces Positive Topline Outcomes for Both Phase 3 Pivotal Trials of iDose TR, Achieving Primary Efficacy Endpoints and Demonstrating Favorable Tolerability and Safety Profiles. Glaukos. September 7, 2023. Accessed December 14, 2023.
Related Videos
Jonathan Barratt, MD | Credit: IgA Nephropathy Foundation
HCPLive Five at ACC 2024 | Image Credit: HCPLive
Jonathan Barratt, MD | Credit: IgA Nephropathy Foundation
Sunny Rai, PhD: “I” Language Markers Do Not Detect Depression in Black Individuals
Ankeet Bhatt, MD, MBA | Credit: X.com
Ankeet Bhatt, MD, MBA | Credit: X.com
© 2024 MJH Life Sciences

All rights reserved.