ALIM Alimera Sciences Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
Iluvien
Diabetic macular edema
|
Approved
Approved
|
CRL Nov 2011. Second CRL Oct 17 2013. Approved Sept 26 2014
|
Latest News
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ATLANTA, Sept. 15, 2020 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (NASDAQ:ALIM) (Alimera), a pharmaceutical company that specializes in the development and commercialization of prescription ophthalmic pharmaceuticals, announces that Alimera Sciences Europe Limited, its Ireland-based European subsidiary, has signed a distribution agreement with Medis Pharmaceutical Company d.o.o. (Medis) for the exclusive sales and distribution of ILUVIEN® in the Czech Republic and Austria. ILUVIEN is Alimera's sustained release intravitreal injection approved in these countries for both the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies and prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment (NIPU).
Medis will immediately assume responsibility for promotion, marketing and commercial activities in Austria where ILUVIEN is currently reimbursed. Additionally, Medis will commence negotiations in the Czech Republic with the State Institute for Drug Control regarding the appropriate public price and confidential net price for reimbursement of ILUVIEN in advance of the initiation of promotion, marketing and commercial activities.
"This agreement furthers Alimera's strategic objective to continue increasing the availability of ILUVIEN in additional European countries to treat patients suffering from both DME and NIPU," said Rick Eiswirth, President and Chief Executive Officer of Alimera. "Medis, with their strong growth and commitment to these markets, makes them a partner of choice, and we are pleased to be working with them as we expand the ILUVIEN franchise globally."
"We are extremely pleased to partner with Alimera to offer ILUVIEN to our customers in both Austria and the Czech Republic," added Martina Perharic, Medis' Chief Executive Officer. "ILUVIEN's CONTINUOUS MICRODOSINGTM technology enables consistent treatment every day for up to three years to reduce the recurrence of disease, which we believe is highly important to physicians and the patients they serve."
About ILUVIEN
Alimera's primary product is ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg sustained release intravitreal implant, injected into the back of the eye. With its CONTINUOUS MICRODOSING™ technology, ILUVIEN is designed to release sub-microgram levels of fluocinolone acetonide, a corticosteroid, for 36 months, to reduce the recurrence of disease, enabling patients to maintain vision longer with fewer injections. ILUVIEN is approved in the U.S., Canada, Kuwait, Lebanon and the U.A.E to treat diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. In 17 European countries, ILUVIEN is indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies. In March 2019, ILUVIEN received approval in these same countries under the Mutual Recognition Procedure for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye. The 17 European countries include the U.K., Germany, France, Italy, Spain, Portugal, Ireland, Austria, Belgium, Denmark, Norway, Finland, Sweden, Poland, the Czech Republic, the Netherlands, and Luxembourg. The non-infectious posterior uveitis indication for ILUVIEN was launched in Germany and the U.K. in 3Q 2019. ILUVIEN is not approved for treatment of uveitis in the United States.
About Diabetic Macular Edema (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 associated with diabetic retinopathy results in swelling of the macula, the condition is called DME. The onset of DME is painless and may go unreported 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. The Wisconsin Epidemiologic Study of Diabetic Retinopathy found that over a 10-year period approximately 19% of people with diabetes included in the study were diagnosed with DME. All people with type 1 or type 2 diabetes are at risk of developing DME.
About Non-Infectious Posterior Uveitis (NIPU)
Posterior segment non-infectious uveitis is a chronic, inflammatory disease affecting the posterior segment of the eye, often involving the retina, and is a leading cause of blindness in developed and developing countries. It affects people of all ages, producing swelling and destroying eye tissues, which can lead to severe vision loss and blindness. Patients with NIPU are typically treated with systemic steroids, which are effective, but over time frequently lead to serious side effects, ranging from acne, weight gain, sleep and mood disorders to hypertension and osteoporosis that can limit effective dosing. Patients then often progress to steroid-sparing therapy with systemic immune suppressants or biologics, which also can have severe side effects, including an increased risk of cancer and infection. As a result, there remains a significant need for new therapies with improved efficacy, tolerability, and safety profiles to manage this disease.
About Alimera Sciences, Inc.
Alimera Sciences is a pharmaceutical company that specializes in the commercialization and development of prescription ophthalmic pharmaceuticals. Alimera is presently focused on diseases affecting the back of the eye, or retina, because these diseases are not well treated with current therapies and affect millions of people in our aging populations. For more information, please visit www.alimerasciences.com.
About Medis d.o.o.
Medis Pharmaceutical Company is a leading independent medical marketing company focused on commercialization of innovative pharmaceutical products, with emphasis on specialty drugs, medical equipment and self-care brands. Medis aims at making the most advanced and effective medical treatments accessible to every patient in the Central and Eastern Europe (CEE) region that represent up to 70 million potential customers. Its fully owned subsidiaries across the CEE region are leveraging its marketing know-how, scientific expertise and product knowledge. It is headquartered in Ljubljana, Slovenia, founded in 1989, and employs more than 350. Learn more about Medis at www.medis.health/en/
Forward Looking Statements
This press release contains "forward-looking statements," within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, Alimera's expectations with respect to Medis' success in managing negotiations for funding in the Czech Republic and promoting ILUVIEN in Austria and the Czech Republic. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of the Company's expectations, and could cause actual results to differ materially from those projected in its forward-looking statements. Meaningful factors which could cause actual results to differ include, but are not limited to, the acceptance of ILUVIEN by payers in the Czech Republic, Medis' ability to launch ILUVIEN in Austria or the Czech Republic, Medis' ability to provide adequate promotion, marketing and commercial support for ILUVIEN, the acceptance by physicians in Austria and the Czech Republic of ILUVIEN for use in their DME and NIPU patients, as well as other factors discussed in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Alimera's Annual Report on Form 10-K for the year ended December 31, 2019 and Quarterly Reports on Form 10-Q for the quarters ended March 31, 2020 and June 30, 2020, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at www.sec.gov.
All forward-looking statements contained in this press release are expressly qualified by the cautionary statements contained or referred to herein. Alimera cautions investors not to rely too heavily on the forward-looking statements Alimera makes or that are made on its behalf. These forward-looking statements speak only as of the date of this press release (unless another date is indicated). Alimera undertakes no obligation, and specifically declines any obligation, to publicly update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
For press inquiries:
Jules Abraham
for Alimera Sciences
917-885-7378
[email protected]For investor inquiries:
Scott Gordon
for Alimera Sciences
[email protected]
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ATLANTA, Sept. 09, 2020 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (NASDAQ:ALIM) (Alimera), a pharmaceutical company that specializes in the development and commercialization of prescription ophthalmic pharmaceuticals, today announces that Rick Eiswirth, President and Chief Executive Officer, will present a corporate overview at the H. C. Wainwright and Company 22nd Annual Global Virtual Investor Conference on Tuesday September 15, 2020 at 3:30 PM ET. To listen to the conference live, please sign up at https://wsw.com/webcast/hcw7/alim/1592203.
An archived presentation will be available from September 16th on the Alimera website at https://investors.alimerasciences.com/alim/corporate_documents?type=100510&template=most_recent_redirect
In addition, Mr. Eiswirth is available for virtual one-on-one meetings from September 14 – 16, 2020. To schedule a meeting please contact the conference coordinator at [email protected].
About Alimera Sciences, Inc.
Alimera Sciences is a pharmaceutical company that specializes in the commercialization and development of prescription ophthalmic pharmaceuticals. Alimera is presently focused on diseases affecting the back of the eye, or retina, because these diseases are not well treated with current therapies and affect millions of people in our aging populations. For more information, please visit www.alimerasciences.com.
For press inquiries:
Jules Abraham
for Alimera Sciences
917-885-7378
[email protected]For investor inquiries:
Scott Gordon
for Alimera Sciences
[email protected] -
View Full Article Hide Full Article
ATLANTA, Sept. 09, 2020 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (NASDAQ:ALIM) (Alimera), a pharmaceutical company that specializes in the development and commercialization of prescription ophthalmic pharmaceuticals, today announces that Rick Eiswirth, President and Chief Executive Officer, will present a corporate overview at the H. C. Wainwright and Company 22nd Annual Global Virtual Investor Conference on Tuesday September 15, 2020 at 3:30 PM ET. A live and archived presentation will be available on the Alimera website at https://investors.alimerasciences.com/ALIM/events/3819.
In addition, Mr. Eiswirth is available for virtual on-on-one meetings from September 14 – 16, 2020. To schedule a meeting contact the conference coordinator at [email protected].
About Alimera Sciences, Inc.
Alimera Sciences is a pharmaceutical company that specializes in the commercialization and development of prescription ophthalmic pharmaceuticals. Alimera is presently focused on diseases affecting the back of the eye, or retina, because these diseases are not well treated with current therapies and affect millions of people in our aging populations. For more information, please visit www.alimerasciences.com.
About Nordic Prime
Nordic Prime is a private owned Danish pharmaceutical distributor, selling to pharmacies and hospitals within the Nordic region. http://www.nordicprime.dk/
Forward Looking Statements
This press release contains "forward-looking statements," within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, Alimera's expectations with respect to access to ILUVIEN for Nordic hospitals and patients. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in its forward-looking statements. Meaningful factors which could cause actual results to differ include, but are not limited to, Nordic Prime's ability to launch ILUVIEN in the Nordic countries, Nordic Prime's ability to successfully obtain tender business for ILUVIEN, the acceptance by physicians in the Nordic countries of ILUVIEN for use with DME and posterior uveitis patients, as well as other factors discussed in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Alimera's Annual Report on Form 10-K for the year ended December 31, 2019 and Quarterly Reports on Form 10-Q for the quarters ended March 31, 2020 and June 30, 2020, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at www.sec.gov.
All forward-looking statements contained in this press release are expressly qualified by the cautionary statements contained or referred to herein. Alimera cautions investors not to rely too heavily on the forward-looking statements Alimera makes or that are made on its behalf. These forward-looking statements speak only as of the date of this press release (unless another date is indicated). Alimera undertakes no obligation, and specifically declines any obligation, to publicly update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
For press inquiries: For investor inquiries: Jules Abraham Scott Gordon for Alimera Sciences for Alimera Sciences 917-885-7378 [email protected] [email protected] -
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ATLANTA, Sept. 08, 2020 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (NASDAQ:ALIM) (Alimera), a pharmaceutical company that specializes in the development and commercialization of prescription ophthalmic pharmaceuticals announces that the Scottish Medicines Consortium (SMC), after completing its assessment and review, has accepted (per label) ILUVIEN® for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIPU).
The decision came following a review of a cost-utility analysis for the prevention of relapse in recurrent non-infectious uveitis based on results from the PSV-FAI-001 clinical study. The analysis compared outcomes following insertion of a fluocinolone acetonide implant at baseline with standard treatment, including systemic corticosteroids or immunosuppressants, topical steroids, intraocular pressure reduction therapy, cataract removal and other elective ocular surgical procedures.
"ILUVIEN becoming available for treatment of NIU-PS through the NHS in Scotland is incredibly welcome news," said Dr Mohan Varikkara, Consultant Ophthalmologist at University Hospital Ayr, Scotland. "It is good to have a treatment option that can be directly delivered into the eye which helps keep inflammation down to non-sight threatening levels. It is a long-acting implant which could potentially work for 3 years to prevent relapse and protect patients from further vision loss while also reducing the need for systemic medications, minimising their associated side effects and decreasing the need for regular blood monitoring, thus reducing the burden for patients."
"This unrestricted reimbursement acceptance further reinforces the clinical value of ILUVIEN in the prevention of relapse, and control of the recurrence, of NIPU," said Rick Eiswirth, President and Chief Executive Officer of Alimera. "We continue to execute on our goal of expanding ILUVIEN's availability and are pleased that physicians and patients of the National Health Service Scotland now have access to ILUVIEN for both our NIPU and diabetic macular edema indications throughout the United Kingdom."
About ILUVIEN
The Company's primary product is ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg sustained release intravitreal implant, injected into the back of the eye. With its CONTINUOUS MICRODOSING™ technology, ILUVIEN is designed to release sub-microgram levels of fluocinolone acetonide, a corticosteroid, for 36 months, to reduce the recurrence of disease, enabling patients to maintain vision longer with fewer injections. ILUVIEN is approved in the U.S., Canada, Kuwait, Lebanon and the U.A.E to treat diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. In 17 European countries, ILUVIEN is indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies. In March 2019, ILUVIEN received approval in the 17 countries under the Mutual Recognition Procedure for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye. The 17 European countries include the U.K., Germany, France, Italy, Spain, Portugal, Ireland, Austria, Belgium, Denmark, Norway, Finland, Sweden, Poland, Czechia, the Netherlands, and Luxembourg. The non-infectious posterior uveitis indication for ILUVIEN was launched in Germany and the U.K. in 3Q 2019. ILUVIEN is not approved for treatment of uveitis in the United States.
About Non-Infectious Posterior Uveitis (NIPU)
Posterior segment non-infectious uveitis is a chronic, inflammatory disease affecting the posterior segment of the eye, often involving the retina, and is a leading cause of blindness in developed and developing countries. It affects people of all ages, producing swelling and destroying eye tissues, which can lead to severe vision loss and blindness. Patients with NIPU are typically treated with systemic steroids, which are effective, but over time frequently lead to serious side effects, ranging from acne, weight gain, sleep and mood disorders to hypertension and osteoporosis that can limit effective dosing. Patients then often progress to steroid-sparing therapy with systemic immune suppressants or biologics, which also can have severe side effects, including an increased risk of cancer and infection. As a result, there remains a significant need for new therapies with improved efficacy, tolerability, and safety profiles to manage this disease.
About Scottish Medicines Consortium
https://www.scottishmedicines.org.uk/
The Scottish Medicines Consortium is a committee of clinicians, pharmacists, National Health Service (NHS)) board representatives, the pharmaceutical industry and the public. Members of the committee consider a broad range of evidence in order to decide which medicines should be accepted for use by National Health Service Scotland.
About Alimera Sciences, Inc.
Alimera Sciences is a pharmaceutical company that specializes in the commercialization and development of prescription ophthalmic pharmaceuticals. Alimera is presently focused on diseases affecting the back of the eye, or retina, because these diseases are not well treated with current therapies and affect millions of people in our aging populations. For more information, please visit www.alimerasciences.com.
Forward Looking Statements
This press release contains "forward-looking statements," within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in its forward-looking statements. Meaningful factors which could cause actual results to differ include, but are not limited to, the willingness of physicians and patients in Scotland to adopt ILUVIEN for treatment of NIPU and the in-market experience of physicians and patients in using ILUVIEN to treat NIPU, as well as other factors discussed in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Alimera's Annual Report on Form 10-K for the year ended December 31, 2019 and Quarterly Reports on Form 10-Q for the quarters ended March 31, 2020 and June 30, 2020, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at www.sec.gov.
All forward-looking statements contained in this press release are expressly qualified by the cautionary statements contained or referred to herein. Alimera cautions investors not to rely too heavily on the forward-looking statements Alimera makes or that are made on its behalf. These forward-looking statements speak only as of the date of this press release (unless another date is indicated). Alimera undertakes no obligation, and specifically declines any obligation, to publicly update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
For press inquiries:
Jules Abraham
for Alimera Sciences
917-885-7378
[email protected]For investor inquiries:
Scott Gordon
for Alimera Sciences
[email protected]coreir.com -
Alimera Sciences Inc. (NASDAQ:ALIM) is a global pharmaceutical company that specializes in the commercialization and development of prescription ophthalmic pharmaceuticals for the treatment of retinal diseases. Alimera is presently focused on diseases affecting the back of the eye, or retina, because these diseases are not well treated with current therapies and affect millions of […]View Full Article Hide Full Article
Alimera Sciences Inc. (NASDAQ:ALIM) is a global pharmaceutical company that specializes in the commercialization and development of prescription ophthalmic pharmaceuticals for the treatment of retinal diseases. Alimera is presently focused on diseases affecting the back of the eye, or retina, because these diseases are not well treated with current therapies and affect millions of people globally. Alimera recently initiated the company’s Phase 4 NEW DAY clinical trial, a randomized, controlled, multi-center study designed to generate prospective data for ILUVIEN(R) (fluocinolone acetonide intravitreal implant) 0.19 mg as a baseline therapy in patients diagnosed with diabetic macular edema (DME).For more information, visit the company’s website at www.alimerasciences.com
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