WASHINGTON — A nanomicellar formulation of cyclosporine A was well tolerated with a low rate of ocular adverse events or instillation site pain, according to a study presented here.
“The OTX-101 formulation was found in this clinical trial to be superior to vehicle in both increasing tear production and improving corneal and conjunctival staining after 12 weeks of therapy in patients with keratoconjunctivitis sicca,” Jodi Luchs, MD, FACS, said at the American Society of Cataract and Refractive Surgery meeting.
Luchs reported the results of a phase 3 study assessing the ocular safety, tolerability and efficacy of OTX-101 (Sun Pharmaceutical Industries), a cyclosporine A 0.09% formulation, compared with vehicle when dosed for 84 days in subjects with keratoconjunctivitis sicca. The study was randomized 1:1 with 372 patients in each group, according to the presentation.
Efficacy was statistically significantly better in the treatment arm (P < .0001) compared with the vehicle arm as demonstrated by percent of eyes with 10 mm or more increase from baseline in Schirmer’s test score, which was the primary efficacy endpoint.
Total conjunctival staining score, a secondary endpoint, was statistically significantly better than vehicle (P = .0007) as well.
Regarding safety, the overall incidence of adverse events was low, Luchs said, with most adverse events related to instillation site pain graded as mild and not requiring treatment.
“These data confirm the results of the previous phase 2b/3 studies,” he said. – by Patricia Nale, ELS
Luchs J. Phase 3 clinical results of cyclosporine 0.09% in a new nanomicellar ophthalmic solution for treatment keratoconjunctivitis sicca. Presented at: American Society of Cataract and Refractive Surgery annual meeting; April 13-17, 2018; Washington.
Disclosure: Luchs reports he is co-medical director of Eyevance Pharmaceuticals and has financial interest in Alcon, Allergan, Avedro, Bausch + Lomb, Bruder, Calhoun Vision, CXLO, Eyevance Pharmaceuticals, iCare, Insightful Solutions, Kala Pharmaceuticals, Omeros, RPS, Shire, Sun Pharmaceutical Industries, TearLab and Trefoil.