Santen Publishes New Data in Glaucoma and Dry Eye Drug Candidates

Santen EMEA shared the preliminary results of its two real world evidence (RWE) studies, VISIONARY and PERSPECTIVE, at this year’s European Society of Ophthalmology (SOE) congress. The studies assessed the impact of the effectiveness, tolerability, and safety of topical preservative-free tafluprost (0.0015%) and timolol (0.5%) fixed-dose combination (taf-tim FC) and cyclosporine (CsA) respectively.

“We are delighted to share the preliminary results of these real world studies in glaucoma and dry eye disease,” Luis Iglesias, Head of Santen EMEA, said in a company news release. “Patients are at the heart of everything we do, so it is our duty to continually assess the impact of our products in different patient segments. And with rising patient populations and pressures on eye health such as increased screen use, and against the backdrop of a number of industry players departing the market in recent years, our commitment and focus on ophthalmology has never been more critical.”

VISIONARY, a recently completed, 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 open-angle glaucoma (OAG) and ocular hypertension (OHT) 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 both at 4 and 12 weeks post initiation of taf-tim FC, and was well tolerated with no serious treatment related adverse events (AEs), whilst key symptoms of ocular surface health improved compared with previous treatments at 3 months. Key findings¹ included:

• Mean IOP reduction from baseline was 5.32±3.45 mmHg (23.3%) at Week 4 and 5.73±3.45 mm Hg (25.3%) at Week 12 (both p<0.001; n=161). Week 12 responder rate (IOP reduction from baseline >20%) was 71.4% (p<0.0001; n=161).
• Conjunctival hyperaemia decreased in 43.6% (p<0.001; n=149) at Week 12 and improvements were seen in dry eye related symptoms (34.6%); (overall improvement p<0.001; n=130), irritation (34.1%; overall improvement p<0.001; n=129) and foreign body sensation (31.8%; overall improvement p=0.005; n=129). Corneal fluorescein staining was reduced in 49.2% at Week 12 (p<0.0001; n=63).
• Most physicians (92.5%) reported improved IOP control with taf-tim FC, versus prior medication.
• Tolerability was rated as good or very good by 87.1% of patients.

PERSPECTIVE, an ongoing non-interventional, multicenter, European, prospective study, evaluated the effectiveness, tolerability and safety of cyclosporine (CsA) in the treatment of severe keratitis in patients with dry eye disease (DED) who had previously failed to respond to artificial tear treatments. Three month data demonstrates CsA provides effective treatment in these patients and is generally well tolerated. Key findings² included:

• Statistically significant reductions in mean CFS score, from baseline (2.64±1.16; n=162), were seen at Week 4 (1.77±1.21; P<0.001; n=94) and Week 12 (1.36±1.10; P<0.001; n=117).
• At Week 4, subjects showed improvements (71.8%) or no change (22.9%) in CFS grade. Week 12 CFS grade was improved for 75.0% and unchanged for 23.1%.
• All subjective symptoms were improved at Weeks 4 and 12. For example, statistically significant improvements were seen at Week 12 in severity of foreign body sensation (p<0.001; n=111), which was mostly improved (45.9%) or maintained (42.3%), and blurred vision (p<0.001; n=112), where 42.0% showed improvements while 51.8% were unchanged. Week 12 conjunctival erythema was reduced (45.8%) or unchanged (46.6%) from baseline (change in severity P<0.001; n=131).

The full results of VISIONARY will be submitted in the autumn, and come amidst numerous recent activities from Santen in EMEA that place emphasis on the importance of patient empowerment in ophthalmology. This includes the recent launch of Santen’s preservative-free multi-dose products in glaucoma, that results in fewer adverse reactions (that can impact patient adherence to medications) and provides people with glaucoma greater control over how they manage their conditions.^3,4 The preliminary results of VISIONARY and PERSPECTIVE also preceed upcoming product launches in the surgical device space, as well as a swathe of ongoing research and development initiatives in numerous therapeutic areas that illustrate how Santen is constantly exploring new possibilities in eye care in an effort to advance the ocular health of patients.

References:

1. PERSPECTIVE ePoster : EP-OCS-16
2. VISIONARY ePoster: EP-GLA-06
3. Steven, DW et al. Preservative in glaucoma medication. British Journal of Ophthalmology. 2018;102:1497-1503
4. Renieri G et al. Efficacy and tolerability of preservative-free eye drops containing a fixed combination of dorzolamide and timolol in glaucoma patients. Journal of Ocular Pharmacology and Therapeutics. 2010;26 (6):597–603