Santen: VISIONARY Study Demonstrates Effectiveness of Tafluprost/Timolol Combination Therapy in Open-Angle Glaucoma
Santen has announced that the results of its real world evidence study, VISIONARY, have been published in Advances in Therapy. The study, which was conducted in 12 countries from across Europe with up to 6-months follow up, demonstrates that preservative-free tafluprost/timolol fixed-dose combination (Taptiqom) provides statistically and clinically significant IOP reductions in the real-world setting. This was demonstrated in patients with open-angle glaucoma (OAG) and ocular hypertension that were insufficiently controlled on or intolerant to prostaglandin analogue (PGA) or beta-receptor blocker monotherapy.[1]
“The VISIONARY study should have a positive impact on the management of glaucoma, because the study generated real-world data based on a large patient population, which provides a clear view into what we can expect in the clinical setting,” Dr. Francesco Oddone, Principal Investigator, VISIONARY, said in a company news release. “The data shows that using preservative-free tafluprost/timolol fixed dose combination therapy can lead to significant IOP reductions and improvements in ocular surface health in those patients who are insufficiently controlled with, or did not tolerate, prostaglandin analogue or beta-blocker monotherapy.”
VISIONARY, a non-interventional, multicenter, European prospective study evaluated the effectiveness, tolerability, and safety of topical preservative-free tafluprost (0.0015%) and timolol (0.5%) fixed-dose combination (taf-tim FC) treatment in routine clinical practice in adults with OAG and ocular hypertension who demonstrated an insufficient response to previous monotherapy treatment with topical beta-blockers or prostaglandin analogues.
Taf-tim FC demonstrated statistically and clinically significant IOP reduction in patients insufficiently controlled on other medications starting at 4 weeks post initiation of taf-tim FC, and this was maintained over the 6-month study period regardless of prior treatment. Key findings included:
Mean IOP reduction from baseline was 5.4±3.76 mmHg (23.7%) at Week 4, 5.9±3.9 mm Hg (25.6%) at Week 12 and 5.7±4.11 mmHg (24.9%) at Month 6 (P<0.0001 at all visits; week 4 n=541; week 12 n=503; month 6 n=577).
Month 6 responder rate (IOP reduction from baseline >20%) was 69.2% (P<0.0001; n=577)
The treatment was well tolerated with no serious treatment related adverse events (AEs), whilst key symptoms of ocular surface health improved compared with previous treatments at week 4 and maintained throughout.
- Conjunctival hyperaemia from Week 4 was significantly reduced, irrespective of prior PGA, and this was maintained throughout all time points up to 38.7% (P<0.0001; n=577) at Month 6.
For patients presenting signs and symptoms at baseline, statistically significant improvements were seen in dry eye related symptoms. At Month 6, overall dry eye severity was reduced by 30.8%, irritation by 31.0% and foreign body sensation in 23.0% of the patients.
Corneal fluorescein staining was reduced in 32.7% of patients at Month 6 (P<0.0001). The mean (SD) CFS score at Month 6 was 0.47 (0.71), which was a statistically significant reduction compared with the mean baseline value (0.76 [0.94]; P<0.0001)
Most physicians (84.7%) reported improved IOP control with taf-tim FC, versus prior medication.
Tolerability was rated as good or very good by 91.4% of patients at Month 6.
Side effects such as redness, itching and streaming, eyelash growth and dark circles under the eyes can occur with some glaucoma medications. These factors can negatively impact patient quality of life, which in turn can result in lower adherence and ultimately, increases to IOP and further progression of glaucoma.[2,3] In addition, complex regimens can further compound adherence problems.[3]
References:
Treatment of open-angle glaucoma and ocular hypertension with preservative-free tafluprost/timolol fixed-dose combination therapy: the VISIONARY study Oddone F, Tanga L, Kothy P, Hollo G and the VISIONARY study group. Adv Ther (2020). https://doi.org/10.1007/s12325-020-01239-8
Do Adherence Rates and Glaucomatous Visual Field Progression Correlate? Rossi et al Eur J Ophthalmol 2011; 21 (4): 410-414
EGS Guidelines 4th Edition. Br J Ophthalmol. 2017 Jun;101(6):130-195. doi: 10.1136/bjophthalmol-2016-EGS guideline.003