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OTX-101 ophthalmic solution 0.09% proven safe, effective for dry eye disease

Stephen Padilla
02 Sep 2019

Treatment with OTX-101 0.09% markedly improves signs of dry eye disease (DED), including tear production and ocular surface integrity, results of a phase III trial have shown.

“Differentiation between the OTX-101 0.09% and vehicle groups in the improvements for multiple clinical signs occurred within 28 days of OTX-101 0.09% treatment initiation,” the researchers said. “The clinical improvement demonstrated in this study supports the continued development of OTX-101 as a treatment for DED.”

Adults with a history and clinical diagnosis of DED, a global symptom score of 40 (range, 0–100), and a lissamine green conjunctival staining score of 3 or 9 (range, 0–12) in at least one eye were included in this randomized, multicentre, vehicle-controlled, double-masked, phase III clinical trial.

Eligible patients had a run-in period of 14–20 days in which all patients administered vehicle twice daily. Those who remained eligible at the baseline (day 0) visit were randomized 1:1 to twice-daily treatment with OTX-101 0.09% (n=371) or vehicle (n=373) for 84 days.

A significantly greater percentage of eyes in the OTX-101 0.09% group achieved the primary endpoint of a clinically meaningful improvement (increase of 10 mm) in Schirmer test score at day 84 compared with those in the vehicle group (16.6 percent vs 9.2 percent; p<0.001). There were also significant improvements observed for corneal (days 28, 56 and 84) and conjunctival (days 56 and 84) staining relative to vehicle. [Ophthalmology 2019;126:1230-1237]

“Improvements in clinical signs were observed as early as day 28 in the present study,” the researchers said. “These … may be the result of the higher ocular tissue concentrations of cyclosporine produced by this novel nanomicellar formulation relative to the currently marketed emulsion.”

Both treatment groups had a reduction in the global symptom score from baseline by approximately 30 percent, but no significant between-group separation was observed. Furthermore, the OTX-101 0.09% formulation was well tolerated, with only mild treatment-emergent adverse events.

“This result is not unexpected, given the well-established discordant relationship between the signs and symptoms of DED and the complex causes of the condition,” the researchers said. [Invest Opthalmol Vis Sci 2003;44:4753-4761]

“The large mean improvement from baseline in both groups may be attributable partially to the regression to the mean effect arising from the requirement of a minimum threshold of 40 in the [Symptom Assessment iN Dry Eye] score,” they added.

The present study was limited by the selection criteria for enrolment, including minimum or maximum characteristics (or both) for conjunctival staining as a clinical sign of DED and the frequency and severity of symptoms of dryness or discomfort related to DED, as well as the relatively short period of treatment (84 days), among others.

“OTX-101 0.09% is a clear aqueous nanomicellar formulation of cyclosporine that may prove to be a useful addition to the armamentarium of agents for the treatment of DED,” the researchers said. “The technology used in the OTX-101 0.09% formulation allows for a stable solution with more than a tenfold increase in the aqueous solubility of cyclosporine.”

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