Posts Tagged ‘ DME ’
pSivida Corp. to Hold Monday November 14 Conference Call to Discuss Complete Response Letter for ILUVIEN® for DME and pSivida’s Product Pipeline
WATERTOWN, Mass.--(BUSINESS WIRE)--pSivida to hold conference call Monday to discuss product pipeline and CRL from FDA for ILUVIEN
Iluvien Update 4: FDA Turns Down Alimera’s NDA for Approval of Iluvien Again
Alimera again received bad news from the FDA on its application for approval of Iluvien. In a letter (a CRL or complete response letter), the FDA said that questions remained based on the data previously submitted, about the adverse reactions shown by Iluvien in the FAME Study (risk of cataracts and raised IOPs) and that these were not offset by the benefits demonstrated.
NICE FAD does not recommend ranibizumab for treatment of diabetic macular oedema
Source: NICE
Area: News
The National Institute for Health and Clinical Excellence (NICE) has issued its Final Appraisal Determination (FAD) on ranibizumab for the treatment of diabetic macular oedema (DMO). Within the FAD, ranibizumab is not recommended for the treatment of visual impairment due to DMO. The FAD also states that people currently receiving ranibizumab for the treatment of visual impairment due to diabetic macular oedema should have the option to continue treatment until they and their clinicians consider it appropriate to stop. The independent Appraisal Committee considered that the manufacturer's model underestimated the incremental cost-effectiveness ratio (ICER) for ranibizumab monotherapy compared with the current standard treatment for people with DMO, laser photocoagulation, which uses heat to seal ocular blood vessels.
Area: News
The National Institute for Health and Clinical Excellence (NICE) has issued its Final Appraisal Determination (FAD) on ranibizumab for the treatment of diabetic macular oedema (DMO). Within the FAD, ranibizumab is not recommended for the treatment of visual impairment due to DMO. The FAD also states that people currently receiving ranibizumab for the treatment of visual impairment due to diabetic macular oedema should have the option to continue treatment until they and their clinicians consider it appropriate to stop. The independent Appraisal Committee considered that the manufacturer's model underestimated the incremental cost-effectiveness ratio (ICER) for ranibizumab monotherapy compared with the current standard treatment for people with DMO, laser photocoagulation, which uses heat to seal ocular blood vessels.
NICE Turns Down Lucentis (Ranibizumab) For Diabetic Macular Edema Treatment, UK
NICE (National Institute for Clinical Excellence) in the UK has decided not to recommend Lucentis (ranibizumab) for diabetic macular edema (British spelling: oedema) treatment. NICE approves or turns down treatments that will be covered by the NHS (National Health Service), the UK's universal health care system...
Novartis Fails to Win UK Backing for Lucentis in Diabetic Eye Condition
Novartis AG, Europes second-largest drugmaker, failed to win approval from the U.K.s health-cost agency for its drug Lucentis in diabetics who suffer an eye condition. Lucentis wasnt cost effective in patients with macular edema, the National Institute for Health and Clinical Excellence said today in a statement. The medicine costs 742 pounds ($1,200) for a monthly injection, NICE said. The agency advises the U.K.s state-run National Health Service on which treatments represent value for money.
Alimera Sciences Says Iluvien Effective at 3 Years
Iluvien, a sustained release drug-delivery system for the treatment of diabetic macular edema, may be getting closer to possible FDA approval. The parent company, Alimera Sciences has resubmitted additional safety and efficacy data as requested by the FDA last year. The FDA requested that they be given data extending for a 3 year period instead of the 2 years in the new drug application.
Iluvien Update: FDA Marketing Approval Delayed
At that time, Alimera Sciences, the company developing Iluvien (under license from pSivida) had filed a new drug application (NDA) to treat diabetic macula edema (DME). The company obtained priority review status for the NDA at the end of August, raising the expectation that an approvable letter might be obtained by the end of 2010. However, instead of an approvable letter, Alimera Sciences received a “complete response letter” (CRL) from the FDA, communicating to the company that its NDA application “cannot be approved in its present form”.
How Effective Are AMD Drugs in Treating Diabetic Macular Edema?
At the AAO meeting in October, researchers reported that anti-VEGF drugs such as ranibizumab (Lucentis) and pegaptanib (Macugen) also appeared to be effective in improving visual acuity in patients with diabetic macular edema in a series of randomized, controlled trials.
Safety and Efficacy of Ranibizumab in Diabetic Macular Edema (RESOLVE Study): A 12-Month, Randomized, Controlled, Double-masked, Multicenter Phase II Study
Ranibizumab is investigated as a possible new treatment for diabetic macular edema (DME).
Diabetes Care
Diabetes Care
Lucentis receive DME approval in EU
(Ophtalmology Times Europe)
Novartis has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for its therapy Lucentis for the treatment of patients with diabetic macular oedema (DME).
Full Story ->
Anti-VEGF Therapy and Laser: Changing the Game in Diabetic Macular Edema Treatment
New studies show that anti-VEGF therapy in combination with laser produces significant results in DME. Dr. David Brown discusses what may be the new standard of care in this video commentary.
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