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Das die Engländer sich immer quer stellen müssen 
Jetzt versucht Alimera über einen anderen Weg an ihr Ziel zu kommen.
January 23, 2013 7:41 AM EST http://www.streetinsider.com/Corporate+News/U.K.+NICE+Publis…
Overall Analyst Rating:
BUY (= Flat)
pSivida Corp. (NASDAQ: PSDV) announces that the United Kingdom’s National Institute for Health and Clinical Excellence (NICE) has published final guidance indicating that ILUVIEN® is not cost effective for the treatment of chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. This final guidance is consistent with the final draft guidance issued on November 29, 2012.
pSivida’s licensee for ILUVIEN for DME, Alimera Sciences, Inc., reported that it has chosen to pursue a Patient Access Scheme (PAS) for ILUVIEN for DME that is intended to allow treatment decisions to be based on patient need, rather than cost. Alimera further reported that the PAS is currently under review by the Patient Access Schemes Liaison Unit (PASLU) at NICE and that, if approved by the Department of Health, the PAS will be available to the Appraisal Committee for review and consideration. Alimera stated its belief that the PAS could be considered under NICE’s rapid review facility should the PAS be accepted.
Jetzt versucht Alimera über einen anderen Weg an ihr Ziel zu kommen.
January 23, 2013 7:41 AM EST http://www.streetinsider.com/Corporate+News/U.K.+NICE+Publis…
Overall Analyst Rating:
BUY (= Flat)
pSivida Corp. (NASDAQ: PSDV) announces that the United Kingdom’s National Institute for Health and Clinical Excellence (NICE) has published final guidance indicating that ILUVIEN® is not cost effective for the treatment of chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. This final guidance is consistent with the final draft guidance issued on November 29, 2012.
pSivida’s licensee for ILUVIEN for DME, Alimera Sciences, Inc., reported that it has chosen to pursue a Patient Access Scheme (PAS) for ILUVIEN for DME that is intended to allow treatment decisions to be based on patient need, rather than cost. Alimera further reported that the PAS is currently under review by the Patient Access Schemes Liaison Unit (PASLU) at NICE and that, if approved by the Department of Health, the PAS will be available to the Appraisal Committee for review and consideration. Alimera stated its belief that the PAS could be considered under NICE’s rapid review facility should the PAS be accepted.
Alimera Receives Marketing Authorization In Spain for ILUVIEN
Charles Gross, Benzinga Staff Writer January 17, 2013 7:32 AM
Alimera Sciences, Inc., (NASDAQ: ALIM [FREE Stock Trend Analysis]) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced the Spanish Agency of Drugs and Medical Devices (Agencia Espanola de Medicamentos y Productos Sanitarios) has granted marketing authorization to ILUVIEN® for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
This marketing authorization follows the completion of the Decentralized Regulatory Procedure (DCP) in the European Union (EU), in which the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, serving as the Reference Member State (RMS), delivered a positive outcome for ILUVIEN along with six Concerned Members States (CMS), specifically Austria, France, Germany, Italy, Portugal and Spain. The Spanish authorization is the sixth national approval in the EU, preceded by Austria, the United Kingdom, Portugal, France and Germany.
"ILUVIEN has now been granted marketing authorizations in six of the seven EU countries in which we have applied," said Dan Myers, president and chief executive officer, Alimera. "With our European management team now on board, we are looking forward to the initial commercial launch of ILUVIEN in Germany, expected during the first quarter of 2013. In addition, we continue to work closely with the Italian regulatory authorities to secure marketing authorization in Italy."
The International Diabetes Federation estimates that more than 3 million people are currently living with diabetes in Spain, approximately 160,000 of whom Alimera estimates suffer from vision loss associated with DME.
ILUVIEN is Alimera's sustained release intravitreal implant that delivers sub-microgram levels of fluocinolone acetonide (FAc) for up to 36 months for the treatment of chronic DME. The clinical trial data showed that in patients with chronic DME at month 30, after receiving the ILUVIEN implant, 38 percent of patients experienced an improvement from baseline in their best corrected visual acuity on the Early Treatment of Diabetic Retinopathy Study (ETDRS) eye chart of 15 letters or more. At the completion of the 36-month study, 34 percent had achieved the same result. This effect was highly statistically significant as compared to the sham control group, which received laser and other intravitreally administered therapies.
"As ophthalmologists, we've been limited in our ability to provide relief for chronic diabetic macular edema patients when existing therapies have stopped working," said José Maria Ruiz Moreno, professor of Ophthalmology, University of Castilla La Mancha. "With its approval, ILUVIEN covers an important gap in the range of treatment options for chronic diabetic macular edema, and it becomes a source of hope for patients who face the threat of blindness."
About ILUVIEN®
ILUVIEN (190 micrograms fluocinolone acetonide intravitreal implant in applicator) is a sustained release intravitreal implant used to treat patients with chronic DME considered insufficiently responsive to available therapies. Each ILUVIEN implant provides a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of fluocinolone acetonide (FAc). ILUVIEN is injected in the back of the patient's eye to a position that takes advantage of the eye's natural fluid dynamics. The applicator employs a 25-gauge needle, which allows for a self-sealing wound. In Alimera's FAME™ Study, the most frequently reported adverse drug reactions included cataract operation, cataract and increased ocular pressure.
About FAME™ Safety
Safety was assessed among those patients treated with ILUVIEN who were in the subgroup of patients with DME for three years or more and were considered to have chronic DME. Intraocular pressure (IOP) increases to 30 millimeters of mercury (mmHg) or greater at any time point were seen in 12.7% of these patients by month 36, compared to 18.4% in the full ILUVIEN treated patient population. By month 36, 3.6% of these patients had undergone an incisional surgical procedure to reduce elevated IOP, compared to 4.8% in the full patient population. The incidence of cataracts among patients with a natural lens in their eye at the start of the study was 84.1% at month 36, with 87.3% undergoing a cataract operation, compared to 81.7% and 80.0%, respectively, in the full patient population.
About DME
DME, the primary cause of vision loss associated with diabetic retinopathy, is a disease affecting the macula, the part of the retina responsible for central vision. When the blood vessel leakage of diabetic retinopathy causes swelling in the macula, the condition has progressed to DME. The onset of DME is painless and may go undetected by the patient until it manifests with the blurring of central vision or acute vision loss. The severity of this blurring may range from mild to profound loss of vision. As the population of people with diabetes increases, it is anticipated that the annual incidence of diagnosed DME will increase.
About Alimera Sciences, Inc.
Alimera Sciences, Inc., based in Alpharetta, Georgia, is a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Alimera Sciences Limited, a wholly owned subsidiary of Alimera, is headquarters of Alimera's European operations in London. Presently Alimera is focused on diseases affecting the back of the eye, or retina. Its primary product, ILUVIEN, is an intravitreal implant containing FAc, a non-proprietary corticosteroid with demonstrated efficacy in the treatment of ocular disease.
Charles Gross, Benzinga Staff Writer January 17, 2013 7:32 AM
Alimera Sciences, Inc., (NASDAQ: ALIM [FREE Stock Trend Analysis]) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced the Spanish Agency of Drugs and Medical Devices (Agencia Espanola de Medicamentos y Productos Sanitarios) has granted marketing authorization to ILUVIEN® for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
This marketing authorization follows the completion of the Decentralized Regulatory Procedure (DCP) in the European Union (EU), in which the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, serving as the Reference Member State (RMS), delivered a positive outcome for ILUVIEN along with six Concerned Members States (CMS), specifically Austria, France, Germany, Italy, Portugal and Spain. The Spanish authorization is the sixth national approval in the EU, preceded by Austria, the United Kingdom, Portugal, France and Germany.
"ILUVIEN has now been granted marketing authorizations in six of the seven EU countries in which we have applied," said Dan Myers, president and chief executive officer, Alimera. "With our European management team now on board, we are looking forward to the initial commercial launch of ILUVIEN in Germany, expected during the first quarter of 2013. In addition, we continue to work closely with the Italian regulatory authorities to secure marketing authorization in Italy."
The International Diabetes Federation estimates that more than 3 million people are currently living with diabetes in Spain, approximately 160,000 of whom Alimera estimates suffer from vision loss associated with DME.
ILUVIEN is Alimera's sustained release intravitreal implant that delivers sub-microgram levels of fluocinolone acetonide (FAc) for up to 36 months for the treatment of chronic DME. The clinical trial data showed that in patients with chronic DME at month 30, after receiving the ILUVIEN implant, 38 percent of patients experienced an improvement from baseline in their best corrected visual acuity on the Early Treatment of Diabetic Retinopathy Study (ETDRS) eye chart of 15 letters or more. At the completion of the 36-month study, 34 percent had achieved the same result. This effect was highly statistically significant as compared to the sham control group, which received laser and other intravitreally administered therapies.
"As ophthalmologists, we've been limited in our ability to provide relief for chronic diabetic macular edema patients when existing therapies have stopped working," said José Maria Ruiz Moreno, professor of Ophthalmology, University of Castilla La Mancha. "With its approval, ILUVIEN covers an important gap in the range of treatment options for chronic diabetic macular edema, and it becomes a source of hope for patients who face the threat of blindness."
About ILUVIEN®
ILUVIEN (190 micrograms fluocinolone acetonide intravitreal implant in applicator) is a sustained release intravitreal implant used to treat patients with chronic DME considered insufficiently responsive to available therapies. Each ILUVIEN implant provides a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of fluocinolone acetonide (FAc). ILUVIEN is injected in the back of the patient's eye to a position that takes advantage of the eye's natural fluid dynamics. The applicator employs a 25-gauge needle, which allows for a self-sealing wound. In Alimera's FAME™ Study, the most frequently reported adverse drug reactions included cataract operation, cataract and increased ocular pressure.
About FAME™ Safety
Safety was assessed among those patients treated with ILUVIEN who were in the subgroup of patients with DME for three years or more and were considered to have chronic DME. Intraocular pressure (IOP) increases to 30 millimeters of mercury (mmHg) or greater at any time point were seen in 12.7% of these patients by month 36, compared to 18.4% in the full ILUVIEN treated patient population. By month 36, 3.6% of these patients had undergone an incisional surgical procedure to reduce elevated IOP, compared to 4.8% in the full patient population. The incidence of cataracts among patients with a natural lens in their eye at the start of the study was 84.1% at month 36, with 87.3% undergoing a cataract operation, compared to 81.7% and 80.0%, respectively, in the full patient population.
About DME
DME, the primary cause of vision loss associated with diabetic retinopathy, is a disease affecting the macula, the part of the retina responsible for central vision. When the blood vessel leakage of diabetic retinopathy causes swelling in the macula, the condition has progressed to DME. The onset of DME is painless and may go undetected by the patient until it manifests with the blurring of central vision or acute vision loss. The severity of this blurring may range from mild to profound loss of vision. As the population of people with diabetes increases, it is anticipated that the annual incidence of diagnosed DME will increase.
About Alimera Sciences, Inc.
Alimera Sciences, Inc., based in Alpharetta, Georgia, is a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Alimera Sciences Limited, a wholly owned subsidiary of Alimera, is headquarters of Alimera's European operations in London. Presently Alimera is focused on diseases affecting the back of the eye, or retina. Its primary product, ILUVIEN, is an intravitreal implant containing FAc, a non-proprietary corticosteroid with demonstrated efficacy in the treatment of ocular disease.
Trading Spotlight
Habe mal bev gefragt,wie sie das jahr bei psivida so sieht
it should be a relatively active year for pSivida I think. In the first
quarter what we are expecting are these items:
* Alimera starting to sell Iluvien in Germany
* Alimera refiling for FDA approval
* possibly some news on the start of pSivida's pivotal phase 3
trials for their version of Iluvien (they are calling it Medidur right now)
for uveitis - as you recall, this is a much smaller trial that has been
approved by the FDA; one year follow up (vs. 3 for DME) and pSivida can
reference ALL of the safety data from the Iluvien trials for DME. pSivida
is very confident about this because they know from their work with Retisert
(same drug basically - different delivery system) that the FDA approved that
drug and it had far worse side effects than the Medidur version. Obviously
this will take some time, but pSivida is excited in this area.
Other things that I think we should hear about in the first half of the year
(could be Q1 or 2) are
* Does the evaluation agreement with Tethadur move to a
license?
* More on the protein delivery system - pSivida is very, very
excited about this. The technology underlying it is the Biosilicon
technology.
* Other sales of Iluvien in Europe
* Other potential license or evaluation agreements
* Some sort of news on the glaucoma product under development
(where Pfizer has the option)
it should be a relatively active year for pSivida I think. In the first
quarter what we are expecting are these items:
* Alimera starting to sell Iluvien in Germany
* Alimera refiling for FDA approval
* possibly some news on the start of pSivida's pivotal phase 3
trials for their version of Iluvien (they are calling it Medidur right now)
for uveitis - as you recall, this is a much smaller trial that has been
approved by the FDA; one year follow up (vs. 3 for DME) and pSivida can
reference ALL of the safety data from the Iluvien trials for DME. pSivida
is very confident about this because they know from their work with Retisert
(same drug basically - different delivery system) that the FDA approved that
drug and it had far worse side effects than the Medidur version. Obviously
this will take some time, but pSivida is excited in this area.
Other things that I think we should hear about in the first half of the year
(could be Q1 or 2) are
* Does the evaluation agreement with Tethadur move to a
license?
* More on the protein delivery system - pSivida is very, very
excited about this. The technology underlying it is the Biosilicon
technology.
* Other sales of Iluvien in Europe
* Other potential license or evaluation agreements
* Some sort of news on the glaucoma product under development
(where Pfizer has the option)
Antwort auf Beitrag Nr.: 43.961.333 von wonner am 27.12.12 10:02:41Wann endet der Winterschlaf, hier?
An alle ein ein Glückliches 2013 (viel Gesundheit und viele Milionen)!
An alle ein ein Glückliches 2013 (viel Gesundheit und viele Milionen)!
Das wünsche ich dir auch!
Das Leben ist eine Achterbahn so wie Psivida ;o)
Das Leben ist eine Achterbahn so wie Psivida ;o)
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