P.J. : Sylentis basa su actividad en la búsqueda de fármacos innovadores empleando la tecnología del ARN de interferencia. Orientada principalmente al área terapéutica de oftalmología, Sylentis cuenta con dos fármacos en ensayos clínicos para las indicaciones de glaucoma y dolor ocular asociado al ojo seco. *************************************
These are the posters that Sylentis will present at ARVO-2016. 1-5 MAY SEATTLE .
1*.- Presentation Number - Posterboard Number: 3040 - A0389
Abstract/Presentation Title: Stability study of Bamosiran (a siRNA compound) in ophthalmic solution in different containers .
Session Number: 314
Session
Title: Glaucoma Clinical studies / Pharmacology Session Date/
Times: May 3, 2016 from 8:30 AM to 10:15 AM
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2*.- Presentation Number - Posterboard Number: 3023 - A0372
Abstract/Presentation Title: Results of Phase IIB SYLTAG clinical trial with bamosiran in patients with glaucoma .
Session Number: 314
Session Title: Glaucoma Clinical studies / Pharmacology
Session Date/ Times: May 3, 2016 from 8:30 AM to 10:15 AM.
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3*.- Presentation Number - Posterboard Number: 2878 - A0087
Abstract/Presentation Title: Results of clinical trials with a novel RNA-based therapy (SYL1001) to treat patients with ocular pain associated to dry eye disease.
Session Number: 310
Session Title: Dry Eye II
Session Date/ Times: May 3, 2016 from 8:30 AM to 10:15 AM
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Martes 3 Mayo 2016 . Congreso ARVO ( Seatle ) .
Results of clinical trials with a novel RNA-based therapy (SYL1001) to treat patients with ocular pain associated to dry eye disease .
Posterboard #: A0087
Abstract Number: 2878 - A0087
Author Block:
Ana Isabel Jimenez , Jose M. Benitez Del Castillo , Javier Moreno-Montanes , Ignacio Jimenez-Alfaro , Francisco Muñoz-Negrete, , Kadi Palumaa , Krista Turman , Covadonga Paneda , Tamara Martinez , Veronica Ruz , Victoria Gonzalez .
Purpose:
To present the results of 2 dose-finding clinical trials (NCT01776658, EudraCT No: 2012-001177-93 & NCT02455999, EudraCT No: 2014-004857-15) to assess the safety and efficacy of SYL1001 in patients suffering of ocular pain associated to dry eye disease.
Methods:
SYL1001 eye drops is a novel RNAi based drug in development by Sylentis. Two phase 2, multicenter, randomised, parallel groups, placebo-controlled, double-masked clinical trials have been run in parallel to evaluate the safety and efficacy of SYL1001.
The primary objective was to compare the analgesic effect (VAS & OSDI scales) and ocular tolerance (Oxford scale & conjunctival hyperaemia) of 4 doses of SYL1001 after 10 days of treatment.
The secondary objective was to assess the local (visual acuity, intraocular pressure (IOP), Schirmer’s test and tear break-up time (BUT)), systemic tolerance and adverse events (AEs) occurrence.
Statistics:
The Tukey or Wilcoxon method was used for pairwise comparisons between treatments, and the variable treatment was assessed using the ANOVA test. The level of statistical significance for all tests is set at p = 0.05.
Results:
A total of 127 patients were randomized into five arms (0.375%, 0.75%, 1.125% and 2.25% of SYL1001 q.d and Placebo (vehicle) q.d) in two clinical trials conducted in Spain and Estonia. All doses of SYL1001 reduced the VAS scale. The dose of 1.125% was significant better (p=0.016) than placebo. There were not significant differences in the OSDI value between placebo and SYL1001 groups after 10 days of treatment. The corneal staining indicated that the dose of 1.125% of SYL1001 was better tolerated than placebo.
Safety results:
No deaths, no unexpected or serious AEs related to SYL1001 have been reported. No statistical differences were found between the numbers of AEs reported in the SYL1001 groups and placebo. Vital signs, physical examination, biomicroscopy, ophthalmoscopy assessment and electrocardiogram did not show significant abnormalities.
Conclusions:
Ocular pain is a high incidence disease with no specific treatments. SYL1001 is a new RNA based drug on development for the treatment of ocular pain associated to dry eye disease. The results of Phase 2 clinical trials indicate that SYL1001 is an ideal candidate for treating this pathology. Phase 3 results should confirm the promising results obtained in these clinical trials.
Layman Abstract (optional):
Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details.:SYL1001 eye drops is a novel RNAi based drug in development by Sylentis for the ocular pain asociated to dry eye. Ocular pain is a high incidence disease with no specific treatments.
The results of Phase 2 clinical trials indicate that SYL1001 is an ideal candidate for treating this pathology. Phase 3 results should confirm the promising results obtained in these clinical trials.