Preservative-free tafluprost in the treatment of naive patients with glaucoma and ocular hypertension

Abstract

Ines Lanzl,1 Thomas Hamacher,2 Klaus Rosbach,3 Mohammed Osman Ramez,4 Robert Rothe,5 Eva Ružicková,6 Marta Karhanová,7 Friedemann Kimmich81Private practice, Prien, Germany; 2Private practice, Starnberg, Germany; 3Private practice, Mainz, Germany; 4Private practice, Buxtehude, Germany; 5Private practice, Minden, Germany; 6General Faculty Hospital, Praha Czech Republic; 7Faculty Hospital Olomouc, Czech Republic; 8eyecons, Pfinztal, GermanyPurpose: The study reported here investigated the efficacy, tolerability, and safety of the preservative-free prostaglandin analog tafluprost 0.0015% in treatment-naive patients.Patients and methods: Data were collected in two non-interventional, prospective, multicenter, observational, open-label studies of identical design that were conducted in Germany and the Czech Republic. All subjects received preservative-free tafluprost 0.0015% once daily. Intraocular pressure (IOP) levels were recorded for each eye at untreated baseline and 3 months after initiation of medical treatment. The primary outcome was change in mean IOP from baseline to month 3. In the primary open-angle glaucoma (POAG) and ocular hypertension (OH) patient subgroups, analyses were stratified by the level of baseline IOP: ≥20 to 23 mmHg versus ≥24 mmHg. In addition, responder rates and the achievement of pre-specified IOP levels at month 3 were evaluated. Local tolerance of preservative-free tafluprost was evaluated by the patients at final visit. Overall satisfaction with the medical treatment was evaluated by both patients and physicians. All adverse events were recorded.Results: A total of 579 treatment-naive patients with POAG (n = 349), OH (n = 105), normal tension glaucoma (n = 71), exfoliative glaucoma (n = 27), or other glaucomas (n = 27) were included in this observational study. Mean IOP level at baseline for all patients was 23.6 ± 4.0 mmHg. Mean IOP at month 3 was 16.8 ± 2.9 mmHg (—28.8% vs baseline). At month 3, significant reductions in mean IOP (P < 0.001) were seen in all patients and all subgroups. Preservative-free tafluprost lowered mean IOP significantly in patients with POAG and OH with IOP levels ≥ 20 to 23 mmHg from 21.9 ± 1.1 mmHg at baseline to 16.5 ± 2.2 mmHg, and in the subgroup with IOP levels ≥ 24 mmHg from 26.2 ± 2.4 mmHg to 17.9 ± 2.4 mmHg. In the subgroups of patients with POAG and OH, an IOP response ≥20%, ≥30%, and ≥40% was achieved by 83.4%, 44.1%, and 12.8%, respectively. Overall, patients with higher baseline IOP values showed a better response than patients with lower baseline IOP levels. Preservative-free tafluprost was well tolerated and safe. After 3 months, 97.9% of all patients remained on therapy.Conclusion: In this real-world observational study, treatment with once-daily preservative-free tafluprost proved efficacious, well tolerated, and safe in treatment-naive patients.Keywords: intraocular pressure, prostaglandin analogs, responders, first-line treatment, preservatives, local tolerability