Quick Hits

Large blepharitis trial yields mixed results

A cure may be out of reach.

InSite Vision says the largest study of an investigational blepharitis therapy ever attempted has resulted in mixed results. While the DOUBle phase 3 clinical trial of AzaSite Plus and DexaSite for moderate-to-severe blepharitis did not meet the primary endpoint of complete resolution of all clinical signs and symptoms of blepharitis, the company says the combination did demonstrate statistically significant improvements in the clinical signs and symptoms at day 15.

InSite Vision says the results of this multi-product, 907-patient phase 3 study “further reinforce the emerging clinical viewpoint that blepharitis is a chronic and persistent disease that may require a different approach based on clinically achievable and meaningful improvement rather than a cure that is sought for an acute disease.” The company says this finding is consistent with the views of an increasing number of clinicians.

InSite Vision has scheduled a meeting with the FDA to review the overall results of the DOUBle (Dual Ophthalmic agents Used in Blepharitis) study. The company says blepharitis affects an estimated 34 million Americans.

“Currently, there is no pharmaceutical agent approved to help these patients,” says Kamran Hosseini, MD, PhD, chief medical officer of InSite Vision. “This phase 3 trial was designed to improve our understanding of this complex ophthalmic condition by defining quantitative and qualitative measures of meaningful clinical improvement by which our clinical candidates could be evaluated. Our preliminary findings indicate that AzaSite Plus and DexaSite may have clinical benefit even though they did not meet the primary endpoint of the study.”

The DOUBle study was a randomized, double-blind, four-arm clinical trial designed to evaluate the efficacy and safety of both product candidates simultaneously. Across all four arms, fewer than 7% of subjects reached a disease severity score of zero, which would have indicated a clinical “cure” of all signs and symptoms of their disease. Although the AzaSite and DexaSite combination had the most patients who achieved a disease severity score of zero with 25 (8.4%), none of the four arms reached statistical significance.

Pain thresholds may affect symptoms of dry eye disease

Large study measures pain sensitivity and tolerance.

High pain sensitivity and low pain tolerance appear to be associated with symptoms of dry eye disease (DED), according to a study by Jelle Vehof, PhD, of University Medical Center Groningen, the Netherlands, and colleagues. The study was published in August in JAMA Ophthalmology online.¹

A total of 1,635 female twin volunteers, ages 20 to 83 years from the Twins UK adult registry, participated in the population-based cross-sectional study, and 438 (27%) were categorized as having DED. A subset of 689 women completed the Ocular Surface Disease Index (OSDI) questionnaire.

Quantitative sensory testing using heat stimulus on the forearm was used to assess pain sensitivity (heat pain threshold [HPT]) and pain tolerance (heat pain suprathreshold [HPST]).

Women with DED showed a significantly lower HPT and HPST and hence had higher pain sensitivity than those without DED. The study found a strong association between the presence of pain symptoms on the OSDI and the HPT and HPST.

Participants with an HPT below the median had DED pain symptoms more often than those with HPT above the median (31.2% versus 20.5%), according to study results.

The researchers found strong evidence that high pain sensitivity and low pain tolerance are associated with symptoms of DED, adding to previous associations of the severity of tear insufficiency, cell damage and psychological factors.

“Management of DED symptoms is complex, and physicians need to consider the holistic picture, rather than simply treating ocular signs,” the authors concluded.

REFERENCE

1. Vehof J, Kozareva D, Hysi PG, et al. Relationship between dry eye symptoms and pain sensitivity. AMA Ophthalmol. 2013; Aug 1. [Epub ahead of print]

Group sets sights on medical mission to Grenada

Ophthalmologists pitch in to help inhabitants of Caribbean island.

By Bill Kekevian, Senior Associate Editor

Orazio Giliberti, MD, has been committed to mission programs and volunteerism for decades. He serves as the director of ophthalmology at St. George’s University in Grenada, as well the director of ophthalmology at Seton Hall University, but about five years ago, the government of Grenada approached him formally.

The island’s 110,000 inhabitants have few eye-care options. Dr. Giliberti along with Grenadian ophthalmologist Elliot McGuire, MD, dedicated their time and energies to bringing quality eye care to the island. With financial assistance from ophthalmic companies, Dr. Giliberti says, “we were able to put together about 27 ophthalmologists from the United States and the United Kingdom to rotate through Grenada over the last few years. We’re asking them for seven to 14 days.”

Dr. Giliberti says medical students today are taught in bioethics courses to engage in charitable causes, but when he was a student that was just called “doing good.” That altruism is something he taught his daughter, herself an ophthalmologist who started a clinic in Grenada.

Those who have joined his cause, he says, are “some really big names, godfathers of ophthalmology. And the list just gets longer and longer.”

“We are always looking to get more doctors involved in the project,” says Danielle Pennisi, front office customer service representative at Giliberti Eye and Laser Center in Totowa, N.J. Ophthalmologists interested in joining the mission may call Dr. Giliberti’s office at (973) 595-0011.