Bonjour,
Sur Alerterading, apparemment déjà connus mais résultats positifs confirmés....
http://www.alertetrading.com/vesneo-de-nicox-ameri can-glaucoma-society-2015 /
Lors de l’American Glaucoma Society 2015, le docteur Liu a présenté les dernières avancées concernant les recherches sur bunod latanoprostene (VESNEO). Bien que ces résultats soient très prometteurs, ils doivent encore être finalisés et validés. Le docteur Liu indique qu’un essai clinique de plus grande envergure est actuellement en cours.
Si les données venaient à se confirmer, il semblerait que le Vesneo se révèle supérieur à celui du traitement de comparaison, la différence étant semble-t-il statistiquement significative.
Pour rappel : En septembre 2014, Bausch + Lomb et Nicox ont annoncé les premiers résultats positifs obtenus dans les études pivotales de phase 3 conduites avec VESNEO. Ces études ont atteint leur critère d’évaluation principal d’efficacité et ont montré des résultats positifs sur plusieurs critères d’évaluation secondaires. Les pics de ventes de ce médicament pourraient atteindre environ 500 millions de dollars aux États-Unis et environ 1 milliard de dollars à l’échelle mondiale.
Bausch + Lomb prévoit de soumettre un dossier de demande d’autorisation de mise sur le marché (New Drug Application, NDA) pour VESNEO auprès de la FDA américaine (Food and Drug Administration) mi-2015. Le lancement du produit pourrait intervenir au cours du premier semestre 2016, sous réserve d’approbation de la FDA.
Affaire à suivre !
Source de l’information : Latanoprostene Beats Timolol for Ocular Perfusion Pressure (Laird Harrison – February 27, 2015)
« CORONADO, California — In patients with open-angle glaucoma, the experimental drug latanoprostene bunod improves ocular perfusion pressure more than the beta-blocker timolol maleate, and fewer doses are required, according to a new study.
Latanoprostene is « much better than beta blockers, but whether it’s better than other prostaglandins » is not clear from these data, said study investigator John Liu, PhD, from the University of California at San Diego.
Dr Liu presented the findings here at the American Glaucoma Society 2015 Annual Meeting.
Latanoprostene bunod is a novel nitric-oxide-donating prostaglandin F₂-alpha analog. It is rapidly metabolized in situ to latanoprost acid and butanediol mononitrate.
Nicox and Bausch & Lomb are conducting research on latanoprostene bunod. The companies hope to market the agent as Vesneo for the treatment for intraocular pressure in open-angle glaucoma.
Last September, the companies announced that their phase 3 studies demonstrated that latanoprostene reduced intraocular pressure during both the day and night, whereas timolol only reduced it at night.
In their study, Dr Liu’s team looked at the effect of latanoprostene on ocular perfusion pressure. Previous studies have suggested that ocular perfusion pressure is a risk factor for glaucoma progression because it causes hypoperfusion of the optic nerve head.
Sitting ocular perfusion pressure was calculated as 95/140 times the mean blood pressure minus intraocular pressure. Supine pressure was calculated as 115/130 times the mean blood pressure minus intraocular pressure.
In the 25 patients with open-angle glaucoma or ocular hypertension, intraocular pressure was at least 22 mm Hg in one eye, and at least 36 mm Hg in both eyes.
Patients were randomly assigned to 4 weeks of treatment with one drop of 0.024% latanoprostene ophthalmic solution each evening at 8:00 or timolol 0.5% twice a day.
The patients then switched treatments and continued on the other study drug for another 4 weeks.
Of the 25 patients, one discontinued because of an adverse reaction, two withdrew their consent, and one was lost to follow-up.
During the latanoprostene phase, the mean increase from baseline in daytime sitting ocular perfusion pressure was 3.8 mm Hg (P < .01) and in nighttime supine pressure was 2.2 mm Hg (P < .01).
During the timolol phase, the mean increase from baseline in daytime sitting pressure was 2.0 mm Hg, the mean increase in daytime supine pressure was 2.2 mm Hg, and the mean decrease in nighttime supine pressure was –1.3 mm Hg.
The difference in the change from baseline between latanoprostene and timolol was significant for daytime sitting and nighttime supine pressure (P ≤ .02).
Although these findings are promising, they need to be validated, said Dr Liu. A larger clinical trial of these effects is underway, he reported.
Getting the same or better effects from fewer doses of medication could help glaucoma patients a lot, said Robert Stamper, MD, from the University of California at San Francisco, who was not involved in the study.
« If the data hold, it looks like it’s a slightly more powerful medication, » Dr Stamper told Medscape Medical News. For some patients, latanoprostene could make the difference « between taking a medication that they are more likely to adhere to and one they are less likely to adhere to. »
This study was funded by Bausch & Lomb. Dr Liu has disclosed no relevant financial relationships. Dr Stamper reports that he is principal investigator of a study of a drug made by Aerie Pharmaceuticals. »
American Glaucoma Society (AGS) 2015 Annual Meeting: Abstract 15. Presented February 26, 2015.
http://www.medscape.com/viewarticle/840657
