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Auf der Suche nach Erfahrungen mit Iluvien bin ich auf diesen Artikel gestoßen. Ist zwar vom Juni dieses Jahres, ich glaube aber, dass er noch nicht gepostet wurde.
http://www.egms.de/static/de/meetings/doc2015/15doc170.shtml
http://www.egms.de/static/de/meetings/doc2015/15doc170.shtml
Und noch eine Nachricht von heute:
Alimera Sciences Limited Announces ILUVIEN® Study Results Presented At 15th Euretina Congress
By PR Newswire, September 24, 2015, 07:30:00 AM EDT
Vote up AAA
Interim six-month data confirms ILUVIEN was well tolerated and effective in reducing retinal thickness and increasing best corrected visual acuity
ATLANTA and LONDON, Sept. 24, 2015 /PRNewswire/ -- Alimera Sciences, Inc., (NASDAQ:ALIM) (Alimera), a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, announced that Alimera Sciences Limited, its European subsidiary based in London, revealed interim six-month data on ILUVIEN® (Fluocinolone Acetonide 190 micrograms intravitreal implant in applicator) from the ongoing study referred to as RESPOND, a non-Randomised, open-label, multicenter phase 4 pilot study on the Effect and Safety of ILUVIEN® Fluocinolone Acetonide in chronic diabetic macular edema Patients cOnsidered iNsufficiently responsive to available therapies with or without intravitreal corticosteroiD therapy. The study is focused on the efficacy and safety of ILUVIEN, the first sustained release pharmaceutical product for the treatment of vision impairment associated with chronic diabetic macular edema (DME), considered insufficiently responsive to available therapies. The study data were presented at the 15th EURETINA Congress in Nice, France on September 17, 2015.
RESPOND is sponsored by AIBILI (Association for Innovation and Biomedical Research on Light and Image), funded by Alimera Sciences Limited, and is being conducted at four sites in Portugal. RESPOND enrolled 12 patients with chronic DME that did not respond sufficiently to previous treatments, laser and/or anti-vascular endothelial growth factor agents with or without corticosteroids. Each received a single injection of ILUVIEN (190 micrograms intravitreal implant in applicator) and will be followed for 12 months to gauge the effectiveness of the drug to improve visual acuity and reduce retinal thickness. The study will also closely monitor safety variables, such as a rise in intraocular pressure (IOP) and cataract progression.
The interim 6-month results showed that ILUVIEN was well tolerated and effective in reducing retinal thickness and increasing visual acuity. Of 11 patients completing their six-month visit, nine (82%) maintained or improved their Best Corrected Visual Acuity (BCVA) from baseline and 10 patients (91%) experienced a decrease in central subfield thickness (CST). The 11 patients with six months of follow up gained an average of 7.1 letters in BCVA from baseline and experienced an average decrease in CST of 300.6 microns from baseline.
"From clinical practice, we now understand that ILUVIEN provides a confirmed, sustained and fast efficacy with less safety concerns than initially presumed," said Dr. Joao Figueira, RESPOND coordinating investigator and principal investigator for the Center for Clinical Trials at AIBILI in Portugal.
"It is gratifying that ILUVIEN continues to show excellent results both in phase 4 clinical studies and in European physician's practices in patients who were considered insufficiently responsive to other treatments," said Dan Myers, president and chief executive officer, Alimera Sciences. "These early results are consistent with our belief that ILUVIEN would perform as well in clinical practice as was experienced in the FAME Study. We are pleased to work with the AIBILI team as they continue to follow the RESPOND patients, and we look forward to the 12-month results."
Read more: http://www.nasdaq.com/press-release/alimera-sciences-limited…
Alimera Sciences Limited Announces ILUVIEN® Study Results Presented At 15th Euretina Congress
By PR Newswire, September 24, 2015, 07:30:00 AM EDT
Vote up AAA
Interim six-month data confirms ILUVIEN was well tolerated and effective in reducing retinal thickness and increasing best corrected visual acuity
ATLANTA and LONDON, Sept. 24, 2015 /PRNewswire/ -- Alimera Sciences, Inc., (NASDAQ:ALIM) (Alimera), a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, announced that Alimera Sciences Limited, its European subsidiary based in London, revealed interim six-month data on ILUVIEN® (Fluocinolone Acetonide 190 micrograms intravitreal implant in applicator) from the ongoing study referred to as RESPOND, a non-Randomised, open-label, multicenter phase 4 pilot study on the Effect and Safety of ILUVIEN® Fluocinolone Acetonide in chronic diabetic macular edema Patients cOnsidered iNsufficiently responsive to available therapies with or without intravitreal corticosteroiD therapy. The study is focused on the efficacy and safety of ILUVIEN, the first sustained release pharmaceutical product for the treatment of vision impairment associated with chronic diabetic macular edema (DME), considered insufficiently responsive to available therapies. The study data were presented at the 15th EURETINA Congress in Nice, France on September 17, 2015.
RESPOND is sponsored by AIBILI (Association for Innovation and Biomedical Research on Light and Image), funded by Alimera Sciences Limited, and is being conducted at four sites in Portugal. RESPOND enrolled 12 patients with chronic DME that did not respond sufficiently to previous treatments, laser and/or anti-vascular endothelial growth factor agents with or without corticosteroids. Each received a single injection of ILUVIEN (190 micrograms intravitreal implant in applicator) and will be followed for 12 months to gauge the effectiveness of the drug to improve visual acuity and reduce retinal thickness. The study will also closely monitor safety variables, such as a rise in intraocular pressure (IOP) and cataract progression.
The interim 6-month results showed that ILUVIEN was well tolerated and effective in reducing retinal thickness and increasing visual acuity. Of 11 patients completing their six-month visit, nine (82%) maintained or improved their Best Corrected Visual Acuity (BCVA) from baseline and 10 patients (91%) experienced a decrease in central subfield thickness (CST). The 11 patients with six months of follow up gained an average of 7.1 letters in BCVA from baseline and experienced an average decrease in CST of 300.6 microns from baseline.
"From clinical practice, we now understand that ILUVIEN provides a confirmed, sustained and fast efficacy with less safety concerns than initially presumed," said Dr. Joao Figueira, RESPOND coordinating investigator and principal investigator for the Center for Clinical Trials at AIBILI in Portugal.
"It is gratifying that ILUVIEN continues to show excellent results both in phase 4 clinical studies and in European physician's practices in patients who were considered insufficiently responsive to other treatments," said Dan Myers, president and chief executive officer, Alimera Sciences. "These early results are consistent with our belief that ILUVIEN would perform as well in clinical practice as was experienced in the FAME Study. We are pleased to work with the AIBILI team as they continue to follow the RESPOND patients, and we look forward to the 12-month results."
Read more: http://www.nasdaq.com/press-release/alimera-sciences-limited…
Antwort auf Beitrag Nr.: 50.700.102 von wuenschmirwas am 24.09.15 14:45:24Und was macht den Kurs? GO GO RICHTUNG KELLER!!! Schon seltsam, warum?
Eigentlich sollte den Kurs bei 47€ sein
Aber?
Kommt noch?
Eigentlich sollte den Kurs bei 47€ sein
Aber?
Kommt noch?
Trading Spotlight
Zusammenfassung: Erfolgreich nach 8 Monaten!! Wir müssen aber 3 Jahre erfolgreich bleiben, darum ist der Kurs gesunken.Schlussfolgerung: Fluocinolonacetonid zeigt eine gute ödemreduzierende Wirkung mit funktioneller Verbesserung, die nach unserer aktuellen Datenlage mindestens 8 Monate anhält. Das okuläre Nebenwirkungsprofil ist akzeptabel und vergleichbar mit dem von anderen auf dem Markt befindlichen steroidhaltigen Depotpräparaten (Ozurdex). Weiterhin zeichnet sich die Therapie mit einem Steroid-Präparat durch eine deutlich niedrigere Injektionsfrequenz im Vergleich zu der Therapie mit Anti-VEGF-Präparaten aus. Dies bedeutet sowohl eine erhebliche Erleichterung für die Patienten als auch eine Entlastung für das Gesundheitssystem.
Antwort auf Beitrag Nr.: 50.710.356 von N424671 am 25.09.15 17:08:11Das hört sich doch mal gut an!!!!
pSivida Announces NDA for Medidur(TM) Now Planned Using Six-Month Efficacy Data from Both Phase III Trials; FDA Concurs
Top-Line Data from First Trial Expected December 2015
WATERTOWN, Mass.--(BUSINESS WIRE)-- pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug delivery products for treating eye diseases, announced that the Company now plans to file a New Drug Application (NDA) for Medidur for posterior uveitis based on six-month efficacy data for both Phase III trials. The U.S. Food & Drug Administration (FDA) has advised pSivida that this data will be acceptable for review by the agency. pSivida previously planned to utilize 12-month efficacy data from the first trial and six-month efficacy data from the second trial. As six-month visits in the first trial will be completed this month, top-line results from the first Phase III trial are now anticipated to be reported in December 2015. Enrollment in the second Phase III trial continues and is expected to be completed during the first half of 2016, with an NDA anticipated in the first half of 2017.
"We are very pleased that the FDA has agreed to review an NDA for posterior uveitis based on six-month efficacy data," said Dr. Paul Ashton, president and CEO of pSivida. "The primary end-point of the Phase III trials is recurrence of disease, which in the majority of patients occurs typically within six months. Our analysis of the masked data from our first trial is consistent with this. We believe therefore that six-month data from our two trials will show safety and efficacy. We look forward to being able to announce the top-line results from the first trial at the end of this year."
pSivida Announces NDA for Medidur(TM) Now Planned Using Six-Month Efficacy Data from Both Phase III Trials; FDA Concurs
Top-Line Data from First Trial Expected December 2015
WATERTOWN, Mass.--(BUSINESS WIRE)-- pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug delivery products for treating eye diseases, announced that the Company now plans to file a New Drug Application (NDA) for Medidur for posterior uveitis based on six-month efficacy data for both Phase III trials. The U.S. Food & Drug Administration (FDA) has advised pSivida that this data will be acceptable for review by the agency. pSivida previously planned to utilize 12-month efficacy data from the first trial and six-month efficacy data from the second trial. As six-month visits in the first trial will be completed this month, top-line results from the first Phase III trial are now anticipated to be reported in December 2015. Enrollment in the second Phase III trial continues and is expected to be completed during the first half of 2016, with an NDA anticipated in the first half of 2017.
"We are very pleased that the FDA has agreed to review an NDA for posterior uveitis based on six-month efficacy data," said Dr. Paul Ashton, president and CEO of pSivida. "The primary end-point of the Phase III trials is recurrence of disease, which in the majority of patients occurs typically within six months. Our analysis of the masked data from our first trial is consistent with this. We believe therefore that six-month data from our two trials will show safety and efficacy. We look forward to being able to announce the top-line results from the first trial at the end of this year."
Antwort auf Beitrag Nr.: 50.793.267 von N424671 am 07.10.15 12:59:26Egal wie gut die Nachrichten sind, das ding rast richtung Keller
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