According to the company, a PDUFA date has been set for December 22, 2023.
Glaukos Corp. announced it has received the “Day 74” notification from the FDA acknowledging its previously submitted New Drug Application (NDA) for iDose TR (travoprost intraocular implant) is sufficiently complete to permit a substantive review.
According to the company, the Prescription Drug User Fee Act (PDUFA) goal date for the completion of the FDA’s 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 the 505(b)(2) filing.
Thomas Burns, Glaukos chairman and CEO, noted the intraocular implant could shift the paradigm for patient treatment.
"The acceptance of the iDose TR NDA represents another important step in bringing this potential game-changing therapy one step closer to patients who may need a new treatment alternative," Burns said in a news release. "We look forward to working closely with the FDA throughout their review process and continue to 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."
The NDA submission includes data from two Phase 3 pivotal trials of iDose TR, which both successfully achieved the pre-specified primary efficacy endpoints through 3 months and demonstrated a favorable tolerability and safety profile through 12 months. In addition, the submission 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 iDose TR administration demonstrating a favorable safety profile over a 12-month evaluation period.
According to Glaukos, iDose TR is a micro-invasive 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 within the eye for extended periods of time.
Moreover, the company noted it is designed such that it can be removed and replaced with a new iDose TR, thus potentially offering a long-term dropless alternative to daily eye drop treatment. iDose TR is intended to address ubiquitous patient non-compliance and chronic side effects associated with topical IOP-lowering medications.
Glaukos announced the positive topline data for both Phase 3 pivotal trials of iDose TR that achieved its prespecified primary efficacy endpoints through three months in both Phase 3 trials and demonstrated excellent tolerability and a favorable safety profile through 12 months.
“We believe there is an important unmet clinical need and strong appetite within the ophthalmic community for safe, effective and sustained dropless 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 patients around the globe suffering from chronic eye diseases.”
According to the news release, administered during a micro-invasive procedure, the iDose TR contains a novel formulation of travoprost, a prostaglandin analog used to reduce IOP. Once all travoprost is released, the iDose TR was designed to be removed and replaced with a new iDose TR, thus potentially 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 (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 elevated IOP in subjects with open-angle glaucoma (OAG) or ocular hypertension. The two iDose TR pivotal trials are nearly identical in terms of design, protocol, predefined endpoints, size and randomization.
The first of the two Phase 3 pivotal trials, referred to as GC-010, randomized a total of 590 subjects, comprised of 200 subjects in the slow-release iDose TR arm, 197 subjects in the fast-release iDose TR arm and 193 subjects in the timolol active comparator arm. The second of the two Phase 3 pivotal trials, referred to as GC-012, randomized a total of 560 subjects, comprised of 183 subjects in the slow-release iDose TR arm, 185 subjects in the fast-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 across 89 clinical sites.
The primary efficacy endpoint of the Phase 3 studies was a non-inferiority comparison to topical timolol 0.5% BID over the first 3 months, defined as time-matched diurnal IOP measurements at 8 a.m. and 10 a.m. at Day 10, Week 6 and Month 3. Primary safety evaluations were performed through 12 months.
Mean baseline IOP was approximately 24 mm Hg across each arm in each study. Approximately 81% of slow-release iDose TR subjects had OAG while the remaining 19% had ocular hypertension. Approximately 67% of slow-release iDose TR subjects were on one or more IOP-lowering medications at screening, including 23% of subjects who were on two or more IOP-lowering medications at screening.