New fluoroquinolone shows promising results in early trials

FORT LAUDERDALE, Fla. — Besifloxacin ophthalmic solution 0.6% showed good results in six clinical trials, according to a poster presentation here at the Association for Research in Vision and Ophthalmology annual meeting.

Michael R. Paterno, OD, and colleagues reported on phase 1 data on besifloxacin (Bausch & Lomb), a novel fluoroquinolone used for the treatment of bacterial conjunctivitis, as well as safety data from three other randomized, double-masked, parallel group studies.

The researchers looked at the results from treatment on 1,350 patients given besifloxacin for bacterial conjunctivitis. According to the poster, there were no changes in endothelial cell density, with negligible systemic exposure from topical administration. Treatment was not needed for any adverse events, all of which were reported as mild, with the most common being headache, reported in 1.8% of cases.

“Data from six trials with 1,350 subjects demonstrate that besifloxacin ophthalmic suspension 0.6% is safe and well-tolerated,” Dr. Paterno said in the poster.

Besifloxacin is currently under review by the U.S. Food and Drug Administration.

Polymorphism linked to risk of AMD, reduced visual acuity

Analysis of data from the DAWN genetics substudy of ranibizumab trials found that the C5 I802V polymorphism was associated with a risk of age-related macular degeneration, with a noted reaction to the anti-VEGF drug.

“The C5 I802V polymorphism was associated with differential response to ranibizumab, even after adjustments for important baseline covariates,” Jason S. Ehrlich, MD, and colleagues said.

The study analyzed DNA sample results from 352 wet AMD patients. All patients had choroidal neovascularization.

Dr. Ehrlich and colleagues found that the genotype at C5 tended to have worse visual acuity loss in patients who had undergone photodynamic therapy/sham treatment. In patients who underwent Lucentis (ranibizumab, Genentech) treatment, the response was “superior” for each genotype, with the extent of the difference “in the same order as for mean [visual acuity] change,” Dr. Ehrlich and colleagues said.

Corneal measurements unaffected by long-term soft contact lens wear

Use of soft contact lenses for up to 32 years does not appear to have a significant impact on key corneal measurements, a study found.

“Long-term soft contact lens wear seems not to alter the corneal biomechanical properties,” Anja Kissner, MD, and colleagues said.

Dr. Kissner and colleagues conducted a prospective clinical trial of 34 eyes of 17 subjects who wore soft contact lenses. The eyes were divided into two groups: intermediate contact lens wear or long-term wear. Contact lens wear ranged from 2 years to 32 years.

In addition, a control group of 34 eyes of 17 subjects had no history of contact lens use.

The study examined corneal hysteresis and corneal resistance factor by Ocular Response Analyzer (Reichert) and central corneal thickness by ultrasound pachymetry. A formula was used to define results.

The researchers found no statistically significant differences between the two contact lens wear groups and the control group for all measurements and results.

Ophthalmic inserts improve dry eye symptoms

A hydroxypropyl cellulose ophthalmic insert was shown to effectively treat dry eye symptoms and improve the quality of life of patients suffering from moderate to severe dry eye, according to a presenter.

Bruce H. Koffler, MD, presented results of a study of 418 dry eye patients who were given the Lacrisert implant (Aton Pharma).

After an initial general dry eye screening, patients also filled out the Ocular Surface Disease Index questionnaire to measure quality of life. Patients were then trained on inserting the device and contacted by phone at day 3 for follow-up and reinstruction.

“Patient education is very important,” Dr. Koffler said in an interview. “It’s about a 10-minute training session, very similar to contact lens application instruction.”

According to Dr. Koffler’s study, after 1 month of treatment with Lacrisert, patients experienced a significant reduction of dry eye symptoms with fewer occurrences of symptoms, which led to less difficulty performing daily functions and reduced discomfort in situations that exacerbate symptoms, such as driving at night. Other objective measures, such as tear film breakup time and Schirmer’s tests, showed an improvement in symptoms as well.

“We had about 42% patient compliance, which is very good, and there was only one adverse event,” Dr. Koffler said in the interview. Of those who missed doses, 69.4% missed one to five treatments.

Overall, patients reported a 21.3% improvement in OSDI score, according to the poster.

Transpalpebral tonometer tests accurately

The Diaton tonometer measured IOP within 3 mm Hg of the gold standard applanation tonometer in a majority of glaucomatous and nonglaucomatous cases, a study found.

Mark A. Latina, MD, and colleagues found that the Diaton tonometer (BiCOM) measured within 3 mm Hg in 83.3% of eyes when correlated with measurements by Goldmann applanation tonometry.

In an interview, Dr. Latina said IOP measurements with the Diaton tonometer are equivalent to Goldmann applanation tonometry. The Diaton device offers a safe, noncontact method of measuring pressure via the eyelid.

“It works,” he said. “It gives you a reasonable estimation of the pressure without having to anesthetize the cornea through a transpalpebral approach.”

Dr. Latina and colleagues presented results of the study in a poster presentation. The study examined IOP measurements in 66 eyes of 33 consecutive subjects; 46 eyes had glaucoma and 20 did not. Measurements were masked, with one researcher using Goldmann tonometry and another using the Diaton.

Home-based perimeter helps detect early CNV

The Foresee Home preferential hyperacuity perimeter has been shown to accurately detect early choroidal neovascularization in patients using the device at home without supervision, according to a researcher.

Anat Loewenstein, MD, of the Tel Aviv Medical Center, presented the results of a study of 109 patients at risk for developing wet age-related macular degeneration who used the Foresee Home PHP (Notal Vision/MSS).

According to Dr. Loewenstein, the study enrolled intermediate AMD and CNV patients at eight centers in Israel. The patients were given a standard tutorial and short training session and then began using the unsupervised home test. The patients were also given biomicroscopy and fluorescein angiography.

The results of the tests showed a sensitivity of 85% and specificity of 84% with 95% confidence intervals.

“The Foresee Home test distinguishes between intermediate AMD and CNV eyes with high specificity and sensitivity,” she said.

Dr. Loewenstein said in an interview, “These patients are scared to death of losing their vision, especially those who have already lost vision in one eye, so this gives them confidence that we can detect CNV early.”

Seventeen patients were excluded because of early AMD or geographic atrophy, and one was excluded because of poor photographic quality, she said.

According to company literature, the device is expected to be available in the U.S. in 2010.

Topical formulation shown to improve blepharitis

Topical azithromycin solution 1% was shown safe and effective in improving the signs and symptoms of blepharitis in a study.

Gail Torkildsen, MD, and colleagues performed an 8-week, multicenter, clinical study of AzaSite ophthalmic solution (Inspire Pharmaceuticals) on 26 chronic blepharitis sufferers. Twenty-three patients completed the study.

“Treatment with topical azithromycin ophthalmic solution 1% resulted in a significant reduction in the most common eyelid bacterial flora and provided significant improvement in both signs and symptoms of blepharitis,” the researchers said in the poster.

Patients were given drops twice on day 1 and day 2 and then once daily for the remaining 28 days.

The authors added that the improvements lasted up to 4 weeks after treatment.