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Dexamethasone/povidone-iodine effective against adenoviral conjunctivitis
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CHICAGO – A phase 2 study showed SHP640 to have significantly better outcomes in clinical resolution and adenoviral eradication compared with vehicle in patients with acute adenoviral conjunctivitis, Abhijit Narvekar, MBBS, DPM, MS, reported here at the American Academy of Optometry meeting.
“It could be a single treatment option for both adenoviral and bacterial conjunctivitis,” Narvekar, director of global clinical development at Shire, said at an academy-sponsored press conference.
He shared results from a multicenter, randomized, double-masked study comparing 0.1% dexamethasone/0.6% povidone-iodine (SHP640) against povidone-iodine (PVP-I) and vehicle in 144 patients with adenoviral conjunctivitis.
Patients’ mean age was 34.5 years, 66.3% were male, and all were Asian.
To be included in the study, Narvekar said patients must have had a positive RPS AdenoDetector Plus test, reported signs and symptoms of adenoviral conjunctivitis of at least 5 days, best corrected visual acuity of at least 0.60 logMAR in each eye, a diagnosis of suspected acute adenoviral conjunctivitis in at least one eye, plus watery discharge and a bulbar conjunctival redness score of at least 1 (out of 3) in the same eye.
Patients received one drop in both eyes four times a day for 5 days.
Key assessments included clinical resolution and absence of watery conjunctival discharge and bulbar conjunctival redness, Narvekar said. Safety measures included slit lamp biomicroscopy, best corrected visual acuity and adverse events.
At day 6, the percentage of patients with clinical resolution in the study eye was 31.3% for the SHP640 group, 10.9% in the vehicle group and 18% in the PVP-I group, Narvekar reported.
He also said that adenoviral eradication was significantly higher in the SHP640 group (79.2%) compared to vehicle (56.5%) and numerically higher than the PVP-I group (62.0%). Adenoviral eradication was noted in both non-vehicle groups as early as day 3.
The safety analysis population included 176 patients, Narvekar said, and no serious adverse events were seen. The most common were corneal infiltrates, punctate keratitis and eyelid edema.
“SHP640 had significantly better outcomes in clinical resolution and adenoviral eradication compared with vehicle,” Narvekar concluded. “These study results support continued investigation.”
He said that phase 3 studies are being conducted for adenoviral and bacterial conjunctivitis. – by Nancy Hemphill, ELS, FAAO
Disclosure: Narvekar is director of global clinical development at Shire.