Adjunctive Use of Tafluprost with Timolol Provides Additive Effects for Reduction of Intraocular Pressure in Patients with Glaucoma
Authors: Egorov Evgeny , Ropo Auli ,   Tafluprost adjunctive therapy Study Group, Egorov Evgeny , Erichev Valery , Astakhov Yury , Alekseev Vladimir , Takhchidi Khristo , Zhaboedov Gennadiy , Pasechnikova Natalija , Kaljurand Kuldar , Palumaa Kadi , Laganovska Guna , Eugeny Russia–Egorov , Eugeny Alexeevich , Staritskaya Tatianavasi Lierna , Evgen'evna Egorova Tatyana , Borisovna Romanova Tatyana , Sheremetyeva Svetlana Sergeevna , Oganezova Janna Grigorievna , Petrovich Erichev Valeriy , Vagizona Yakoubova Liya , Sergueevich Astakhov Yuri , Alekseevna Dal Galina , Borisovna Lisochkina Alla , Kasimovna Atlasov Aliya , Victorovich Pani Nandrey , Alexeev Vladimir , Levko Michael , Martynova Elena , Kolotov Alexander , Takhchidi Khristoperi Klovich , Mironova Emilia Mikhailovna , Proshina Olga I. , Kozlova Elena E. , Sochinskaya Valentina K. , Grishina Tamara S. , Zhaboedov Gennadiy D. , Zhaboedov Ukraine–Gennadiy D. , Petrenko Oksana V. , Tymoshenkova Oksana Vladymyrivna , Vitovska Oksana P. , Kurilina Olena I. , Parkhomenko Oleg G. , Pasechnokova Natalija V. , Korol Andriy Rostislavovich , Klyuev Georgiy O. , Romodanova Kateryna Sergeevna , Nevska Alla , Padanevych Emiliya , Kaljurand Estonia–Kuldar , Pastak Marko , Seljagina Natalia , Palumaa Kadi , Somma Kaire , Laganovska Latvia–Guna , Baumane Kristine 
Published: January 2018

Purpose

This study investigated the efficacy and safety of tafluprost as an adjunctive therapy to timolol in patients with open-angle glaucoma or ocular hypertension, uncontrolled by timolol monotherapy.

Methods

This was a randomized, double-masked, parallel-group, multinational and multicenter 12-week phase III study. Tafluprost 0.0015% (once daily: 20:10) or vehicle were administered as adjunctive therapy to timolol 0.5% (twice daily: 08:00 and 20:00) for 6 weeks, after which all patients received tafluprost for 6 weeks. Intraocular pressure (IOP) measurements were conducted at 08:00, 10:00, and 16:00 at baseline, and weeks 2, 4, 6, and 12.

Results

A total of 185 patients were randomized to tafluprost (n = 96) or vehicle (n = 89). Reductions in IOP were seen in both groups, which were consistently more pronounced with tafluprost. At week 6, the change from baseline in diurnal IOP ranged from −5.49 to −5.82 mm Hg, and the overall treatment difference (tafluprost vehicle) was −1.49 mmHg (upper 95% confidence interval, −0.66; p<0.001, intention-to-treat population, repeated measurements of the analysis of covariance model). At week 12, the change from baseline ranged from −6.22 to −6.79 mmHg in the tafluprost group. Patients switched from vehicle to tafluprost achieved a similar decrease in IOP to those who received tafluprost throughout the study (group difference at 12 weeks, −0.09 mmHg, p=0.812). There were more ocular adverse events with tafluprost compared with vehicle (42% vs. 29%, respectively), but most were mild in severity.

Conclusions

As adjunctive therapy to timolol, tafluprost achieved a consistently greater reduction in IOP compared with vehicle, and was well tolerated.