Dextenza (sustained release dexamethasone) intracanalicular depot showed benefit in efficacy measure of corneal staining signs of inflammatory dry eye disease for total corneal staining change from baseline at day 30 in a phase 2 study for the treatment of inflammatory dry eye disease, developer Ocular Therapeutix (Bedford, Mass.) said in a news release. Dextenza is designed for extended drug release to the ocular surface for 30 days.

The phase 2 exploratory clinical trial was a prospective, multicenter, randomized, parallel-arm, bilateral, double-masked, vehicle-controlled study to explore the safety and efficacy of Dextenza for the treatment of subjects exhibiting signs and symptoms of moderate to severe dry eye disease. The trial was conducted at 2 sites in the United States that included 43 patients (86 eyes) and was not powered for statistical significance.

Patients achieved significantly greater reduction in intraocular pressure (IOP) at 18 months with use of each additional iStent Trabecular Micro-Bypass Stent, according to Glaukos (Laguna Hills, Calif.), adding study results had been recently published in the peer review literature.

These results "demonstrate the potential of implanting one or more iStents as titratable therapy to achieve different levels of IOP reduction," the company said.

In this prospective, randomized study conducted by multiple surgeons at a single investigational site, 119 subjects with open-angle glaucoma and preoperative unmedicated IOP between 22 mm Hg and 38 mm Hg received 1, 2, or 3 iStents in a standalone procedure. In this study design, selection for the number of stents was based on randomization and not on each glaucoma patient's specific needs. The study design included a primary efficacy endpoint of ≥20% IOP reduction at 12 months from baseline unmedicated IOP without use of prescription eye drops or secondary glaucoma procedures. The secondary efficacy endpoint was IOP ≤18 mm Hg at 12 months without use of prescription eye drops or secondary glaucoma procedures.

Approximately 89%, 90% and 92% of the 1-, 2- and 3-stent groups met the primary and secondary endpoints, respectively. Importantly, nearly two-thirds of patients on single stent therapy alone achieved postoperative pressures of ≤15 mm Hg without medication at 12 months. Moreover, at 18 months, mean unmedicated IOP was 15.9 mm Hg, 14.1 mm Hg, and 12.2 mm Hg in the 1-, 2- and 3-stent groups, respectively. No intraoperative ocular adverse events occurred, and safety data were similar across all stent groups. By month 18, 4 eyes had undergone cataract surgery due to progression of cataract.

NovaTears significantly improve 4 of 5 measures associated with evaporative dry eye disease, developer Novaliq (Heidelberg, Germany) said in a press release. NovaTears was also shown to be safe and well tolerated, and caused no changes in visual acuity or intraocular pressure (IOP). The decrease of the Ocular Surface Disease Index (OSDI) by a mean of 21 points exceeded minimal, clinically important differences for mild or moderate and severe disease.

Of additional interest, the compound's non-blurring, water-free formulation demonstrates "strong spreading abilities due to an extremely low surface tension of just 19.65 mNm compared to water at 72 mNm," study authors said.

In this multicenter, observational, 6-week study, 25 subjects applied one drop of NovaTears to both eyes 4 times daily (24 subjects were female). After 6 weeks, NovaTears treatment led to a "significant reduction of corneal staining, and a significant increase in Schirmer I and tear film break-up time." The OSDI score dropped from a mean of 55 to 34.