Glaukos Shares Positive iDose Clinical Updates

Glaukos has shared several promising clinical updates for its iDose sustained-release procedural pharmaceutical platform, which aims to revolutionize the treatment of open-angle glaucoma (OAG) and ocular hypertension (OHT).

iDose TR: Key Features and Clinical Highlights

The iDose TR is a long-duration prostaglandin analog implant approved for a single administration to reduce intraocular pressure (IOP) in patients with OAG or OHT. Implanted through the trabecular meshwork and Schlemm's canal, the device is designed to deliver sustained IOP reduction directly into the scleral tissue.

36-Month Phase 3 Analysis

A follow-up analysis of Glaukos' two pivotal Phase 3 clinical trials has revealed:

• Sustained IOP Reduction: The 75 mcg dose of iDose TR demonstrated long-lasting and substantial IOP reductions over 36 months.

• Reduced Dependence on Topical Medications: Approximately 70% of iDose TR patients maintained well-controlled IOP with the same or fewer topical medications, compared to 58% of timolol control subjects.

Advancements with iDose TREX

The company has also launched a Phase 2b/3 clinical program for iDose TREX, an enhanced version of iDose TR. The iDose TREX shares a nearly identical design to its predecessor but features double the drug capacity, potentially extending its duration of efficacy.

New Insights from Phase 4 Study

In a separate Phase 4 single-arm clinical study involving 60 OAG patients, iDose TR was evaluated in combination with cataract surgery. Key findings at the 6-month follow-up include:

• A mean IOP reduction of 11.3 mmHg, representing a 44% decrease from baseline.

Leadership Perspective

Thomas Burns, Chairman and CEO of Glaukos, emphasized the significance of these updates:

“We are pleased to share these positive clinical updates on our iDose procedural pharmaceutical platform, helping to further advance our goal to position iDose as a transformative novel platform technology able to fundamentally improve the treatment paradigm for patients with glaucoma or ocular hypertension. We continue to believe there is an important unmet clinical need and strong appetite within the ophthalmic community for safe, effective, and sustained procedural pharmaceutical alternatives to traditional topical medications.”

Addressing Key Challenges

The iDose platform is specifically designed to overcome the limitations of traditional topical medications, such as:

• Non-Adherence: Addressing patient challenges with daily compliance.

• Chronic Side Effects: Providing a safer, long-duration alternative with 24/7 efficacy and minimal side effects.

Looking Ahead

These clinical advancements underscore the potential of the iDose platform to transform the management of glaucoma and ocular hypertension. By offering sustained, effective, and patient-friendly solutions, Glaukos aims to address critical unmet needs and improve outcomes for individuals with chronic eye conditions.