According to Glaukos, the Prescription Drug User Fee Act’s target date for completion of the FDA’s review of the iDose TR NDA is set for December 22, 2023. (Image courtesy of Adobe Stock )
Glaukos Corp. announced today that it has received the FDA’s “Day 74” notification recognizing that its previously submitted New Drug Application (NDA) for iDose TR (travoprost intraocular implant) is sufficiently complete to permit substantial review.
According to the company, the Prescription Drug User Fee Act (PDUFA) target date for the completion of FDA review of the iDose TR NDA is set for December 22, 2023. This date reflects a standard 10-month review period and is consistent with management’s expectations for 505(b)(2) filing.
Thomas Burns, president and CEO of Glaukos, noted that the intraocular implant could change the paradigm of patient treatment.
“The acceptance of the iDose TR NDA represents another important step in bringing this potentially game-changing therapy one step closer to patients who may need a new treatment alternative,” Burns said in a press release. “We look forward to working closely with the FDA throughout its review process and continue to believe that iDose TR can be a transformative new technology capable of fundamentally improving the treatment paradigm for patients with open-angle glaucoma or ocular hypertension.”
The NDA submission includes data from two pivotal Phase 3 trials of iDose TR, which successfully met the pre-specified primary efficacy endpoints at 3 months and demonstrated a favorable tolerability and safety profile at 12 months. In addition, the presentation also includes data from the iDose TR exchange trial, which included a second administration of iDose TR and removal of the original iDose TR, with the second administration of iDose TR demonstrating a favorable safety profile over a 12-month evaluation period.
According to Glaukos, iDose TR is a microinvasive intraocular implant designed to lower IOP in patients with open-angle glaucoma or ocular hypertension. iDose TR is designed to continuously deliver therapeutic levels of a proprietary formulation of travoprost from the eye for extended periods of time.
In addition, the company noted that it is designed so that it can be removed and replaced with a new iDose TR, thus providing a long-term drop-free alternative to daily eye drop treatment. iDose TR is intended to address the ubiquitous patient noncompliance and chronic side effects associated with topical IOP-lowering medications.
Glaukos announced positive data from two pivotal Phase 3 trials of iDose TR that met its pre-specified primary efficacy endpoints over three months in both Phase 3 trials and demonstrated an excellent tolerability and profile of favorable security for 12 months.
“We believe there is a significant unmet clinical need and a strong appetite within the ophthalmic community for safe, effective, and sustained non-drop pharmaceutical alternatives to traditional topical medications,” Burns said in a statement at the time. “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 eye disease patients worldwide chronicles”.
Administered during a microinvasive procedure, iDose TR contains a new formulation of travoprost, a prostaglandin analog used to lower IOP, according to the press release. Once all the travoprost was released, the iDose TR was designed to remove it and replace it with a new iDose TR, thus offering an alternative to daily eye drop treatment.
The iDose TR Phase 3 clinical program consists of two prospective, randomized, double-masked, pivotal clinical trials designed to compare the safety and efficacy of a single administration of one of two iDose TR models with different travoprost release rates (known as fast). and iDose TR slow-release models, respectively) to topical timolol ophthalmic solution, 0.5% BID (twice daily), to reduce elevated IOP in subjects with open-angle glaucoma (OAG) or ocular hypertension . The two pivotal iDose TR trials are nearly identical in design, protocol, pre-defined endpoints, size and randomisation.
The first of two pivotal Phase 3 trials, called GC-010, randomized a total of 590 subjects, consisting of 200 subjects in the slow-release iDose TR arm, 197 subjects in the rapid-release iDose TR arm, and 193 subjects in the timolol active comparator arm. The second of the two pivotal Phase 3 trials, called GC-012, randomized a total of 560 subjects, consisting of 183 subjects in the slow-release iDose TR arm, 185 subjects in the rapid-release iDose TR arm, and 193 subjects in the timolol active comparator arm. In total, the phase 3 trials randomized a total of 1,150 subjects at 89 clinical sites.
The primary efficacy endpoint of the phase 3 studies was a non-inferiority comparison with topical timolol 0.5% BID during the first 3 months, defined as time-matched daytime IOP measurements at 8 and 10 of day 10, week 6 and month 3. Primary safety assessments were performed over 12 months.
The mean baseline IOP was approximately 24 mm Hg in each arm of each study. Approximately 81% of iDose TR slow-release subjects had OAG while the remaining 19% had ocular hypertension. Approximately 67% of iDose TR slow-release subjects were taking one or more IOP-lowering medications at screening, including 23% of subjects taking two or more IOP-lowering medications at screening.
