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, April 28, 2021 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (NASDAQ:ALIM) (Alimera), a global pharmaceutical company that specializes in the commercialization and development of prescription ophthalmic pharmaceuticals for the treatment of retinal diseases, today announced financial results for the first quarter of 2021. Alimera will host a conference call on April 29, 2021, at 9:00 a.m. ET to discuss these results.
"In the first quarter of 2021 we experienced our typical seasonal downturn in revenue versus the fourth quarter of 2020 as well as the continued impact of the COVID-19 pandemic. We expect revenue to rebound in Q2 behind encouraging month-over-month growth in the U.S. as well as the late Q1 demand in some of our key international markets," said Rick Eiswirth, Alimera's President and Chief Executive Officer. "Additionally, we are pleased with our ongoing geographic expansion including availability of ILUVIEN® in the Nordic countries during the first quarter and our recently announced exclusive license agreement with Ocumension for Greater China and the Western Pacific."
First Quarter 2021 Financial Results
Net Revenue
Consolidated net revenue decreased 23% to approximately $11.2 million, compared to $14.5 million for Q1 2020.U.S. net revenue decreased 21% to approximately $5.6 million for Q1 2021 compared to $7.1 million for Q1 2020. The decrease was due to the continuing impact of the COVID-19 pandemic on patients' ability to return to retina offices. End user demand, which represents units purchased by physicians and pharmacies from our distributors, decreased 14% to 737 units during Q1 2021 compared to 855 units during Q1 2020.
The difference between GAAP revenue and end user demand is due to the timing of distributor purchases from Q1 2021 versus Q1 2020. During Q1 2021, our distributors purchased approximately 9% fewer units than were sold to end users while during Q1 2020, our distributors purchased approximately 3% more units than were sold to end users.
International net revenue decreased 25% to approximately $5.6 million for Q1 2021, compared to approximately $7.5 million for Q1 2020. The decrease in international net revenue in Q1 2021 compared to Q1 2020 was due to strong distributor sales in Q1 2020 coupled with the continuing effects of the COVID-19 pandemic, which created lower overall end user demand, and slower than anticipated inventory turnover in distributor markets.
Operating Expenses
Total operating expenses were approximately $12.1 million for Q1 2021, compared to approximately $12.4 million for Q1 2020.Net Loss and Adjusted EBITDA
Net loss for Q1 2021 was $(3.6) million, compared to net loss of approximately $(1.2) million for Q1 2020. "Adjusted EBITDA," a non-GAAP financial measure defined below, was approximately $(1.3) million for Q1 2021, compared to Adjusted EBITDA of approximately $1.3 million for Q1 2020.Net Loss per Share
Basic and diluted net loss per share for Q1 2021 was approximately $(0.63) compared to basic and diluted net loss per share of $(0.24) for Q1 2020.Cash and Cash Equivalents
On March 31, 2021, Alimera had cash and cash equivalents of approximately $8.3 million dollars, compared to $11.2 million in cash and cash equivalents on December 31, 2020.On April 14, 2021 Alimera announced it had received $20.0 million from Ocumension Therapeutics, consisting of a $10.0 million upfront payment for the rights to develop and commercialize Alimera's 0.19mg fluocinolone acetonide intravitreal injection for the treatment of diabetic macular edema and other retina diseases (excluding uveitis) in the Greater China territory and other Western Pacific countries under Ocumension's own distinct trademark, and a $10.0 million purchase of Alimera's common stock in a private offering.
Definition of Non-GAAP Financial Measure
For purposes of this press release, "Adjusted EBITDA" is defined as earnings before interest, taxes, depreciation, amortization, stock-based compensation expenses, net unrealized gains and losses from foreign currency exchange transactions, losses on extinguishment of debt and severance expenses. Please refer to the sections of this press release entitled "Non-GAAP Financial Measure" and "Reconciliation of GAAP Net Income or Loss to Non-GAAP Adjusted EBITDA."Conference Call to Be Held April 29, 2021
A live conference call will be hosted on April 29, 2021 at 9:00 a.m. EST by Rick Eiswirth, president and chief executive officer, and Phil Jones, chief financial officer, to discuss Alimera's financial results and provide an update on corporate developments. Please refer to the information below for conference call dial-in information and webcast registration.Conference date: Thursday, April 29, 2021 9:00 a.m. EST
Conference dial-in: 877-839-2190
International dial-in: 412-317-9583
Conference Call Name: Alimera Sciences (NASDAQ:ALIM) First Quarter 2021 Financial Results Conference Call
Conference Call Pre-registration: Participants are asked to pre-register for the call by navigating to: https://dpregister.com/sreg/10155027/e6f02ce52bPlease note that registered participants will receive their dial-in number upon registration and will dial directly into the call without delay. All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the Alimera Sciences call.
The conference call will also be available through a live webcast which is also available through the company's website.
Live Webcast URL: https://services.choruscall.com/links/alimera210429.html
A replay will be available on Alimera's website, www.alimerasciences.com, under "Investor Relations" one hour following the live call.
Conference Call replay: US Toll Free: 1-877-344-7529
International Toll: 1-412-317-0088
Canada Toll Free: 855-669-9658
Replay Access Code: 10155027
End Date: July 29, 2021About 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.
Non-GAAP Financial Measure
This press release contains a discussion of a non-GAAP financial measure, as defined in Regulation G promulgated under the Securities Exchange Act of 1934, as amended. Alimera reports its financial results in compliance with GAAP but believes that the non-GAAP measure of Adjusted EBITDA provides useful information to investors regarding Alimera's operating performance. Alimera uses Adjusted EBITDA in the management of its business. Accordingly, Adjusted EBITDA for the three months ended March 31, 2021 and 2020 has been presented in certain instances excluding items identified in the reconciliations provided in the table entitled "Reconciliation of GAAP Net Income or Loss to non-GAAP Adjusted EBITDA." GAAP net income or loss is the most directly comparable GAAP financial measure to Adjusted EBITDA.
Adjusted EBITDA, as presented, may not be comparable to similarly titled measures reported by other companies because not all companies may calculate Adjusted EBITDA in an identical manner. Therefore, Adjusted EBITDA is not necessarily an accurate measure of comparison between companies.
The presentation of Adjusted EBITDA is not intended to be considered in isolation or as a substitute for guidance prepared in accordance with GAAP. The principal limitation of this non-GAAP financial measure is that it excludes significant elements required by GAAP to be recorded in Alimera's financial statements. In addition, Adjusted EBITDA is subject to inherent limitations as it reflects the exercise of judgments by management in determining this non-GAAP financial measure.
Forward Looking Statements
This press release contains, and the conference call in which executives of Alimera will discuss this press release may include, "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, the Company's expectation that the ILUVIEN sales will rebound in the second quarter of 2021 despite the continuing COVID-19 pandemic. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change these expectations, and could cause actual results to differ materially from those projected in these forward-looking statements. Meaningful factors that could cause actual results to differ include, but are not limited to, uncertainties associated with (a) the continued effects of COVID-19 on the ability or willingness of patients to visit their retina specialists for ILUVIEN injections; (b) current and future governmental orders and policies adopted by healthcare facilities to address the COVID-19 pandemic, and the duration of these limitations; (c) the recent resurgence of the pandemic in both Europe and parts of the U.S.; (d) the emergence of COVID-19 variants that may increase the transmissibility of the coronavirus or be more deadly, or both; (e) the success or failure of the vaccine campaigns in Alimera's markets; (f) when in fact the pandemic will subside enough to permit Alimera's operations to return to its prior growth trajectory, and whether Alimera will be able to achieve that goal when given that opportunity; as well as the 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, 2020, which is on file with the SEC and is available on the SEC's website at http://www.sec.gov. Additional factors will also be described in those sections of Alimera's Quarterly Report on Form 10-Q for the first quarter of 2021, to be filed with the SEC soon. Alimera undertakes no obligation to publicly update or revise any of the forward-looking statements made in this press release, whether as a result of new information, future events or otherwise, except as required by law. Therefore, you should not rely on these forward-looking statements as representing Alimera's views as of any date after today.
For investor inquiries: For media inquiries: Scott Gordon
for Alimera Sciences
[email protected]Jules Abraham
for Alimera Sciences
[email protected]ALIMERA SCIENCES, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands)March 31, December 31, 2021 2020 (unaudited) CURRENT ASSETS: Cash and cash equivalents $ 8,266 $ 11,208 Restricted cash 35 34 Accounts receivable, net 15,702 17,200 Prepaid expenses and other current assets 3,736 3,718 Inventory 2,591 2,746 Total current assets 30,330 34,906 NON-CURRENT ASSETS: Property and equipment, net 1,559 1,638 Right of use assets, net 619 720 Intangible asset, net 12,359 12,838 Deferred tax asset 720 753 TOTAL ASSETS $ 45,587 $ 50,855 CURRENT LIABILITIES: Accounts payable $ 6,343 $ 7,461 Accrued expenses 2,873 3,197 Paycheck Protection Program (PPP) loan 1,778 1,481 Finance lease obligations 215 209 Total current liabilities 11,209 12,348 NON-CURRENT LIABILITIES: Notes payable 42,352 42,408 Finance lease obligations — less current portion 451 514 Other non-current liabilities 3,535 3,563 COMMITMENTS AND CONTINGENCIES STOCKHOLDERS' DEFICIT: Preferred stock: Series A Convertible Preferred Stock 19,227 19,227 Common stock 58 57 Additional paid-in capital 366,092 365,830 Common stock warrants 370 370 Accumulated deficit (396,557 ) (392,909 ) Accumulated other comprehensive loss — foreign currency translation adjustments (1,150 ) (553 ) TOTAL STOCKHOLDERS' DEFICIT (11,960 ) (7,978 ) TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT $ 45,587 $ 50,855 ALIMERA SCIENCES, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
FOR THE THREE MONTHS ENDED MARCH 31, 2021 AND 2020
(in thousands, except share and per share data)Three Months Ended
March 31,2021 2020 (Unaudited) NET REVENUE $ 11,214 $ 14,535 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION (1,562 ) (1,927 ) GROSS PROFIT 9,652 12,608 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 3,213 2,883 GENERAL AND ADMINISTRATIVE EXPENSES 3,413 2,983 SALES AND MARKETING EXPENSES 4,818 5,870 DEPRECIATION AND AMORTIZATION 638 654 OPERATING EXPENSES 12,082 12,390 (LOSS) INCOME FROM OPERATIONS (2,430 ) 218 INTEREST EXPENSE AND OTHER (1,343 ) (1,292 ) UNREALIZED FOREIGN CURRENCY GAIN (LOSS), NET 125 (81 ) NET LOSS BEFORE TAXES (3,648 ) (1,155 ) PROVISION FOR TAXES — (43 ) NET LOSS $ (3,648 ) $ (1,198 ) NET LOSS PER SHARE — Basic and diluted $ (0.63 ) $ (0.24 ) WEIGHTED AVERAGE SHARES OUTSTANDING — Basic and diluted 5,755,424 4,980,722 RECONCILIATION OF GAAP MEASURES TO NON-GAAP ADJUSTED MEASURES
GAAP NET INCOME OR LOSS TO NON-GAAP ADJUSTED EBITDA
(in thousands)Three Months Ended
March 31,2021 2020 (Unaudited) GAAP NET LOSS $ (3,648 ) $ (1,198 ) Adjustments to net loss: Interest expense and other 1,343 1,292 Provision for taxes — 43 Depreciation and amortization 638 654 Stock-based compensation expenses 262 440 Unrealized foreign currency exchange (gains) losses (125 ) 81 Severance expense 195 — NON-GAAP ADJUSTED EBITDA $ (1,335 ) $ 1,312 
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ATLANTA, April 22, 2021 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (NASDAQ:ALIM) (Alimera) a global pharmaceutical company that specializes in the commercialization and development of prescription ophthalmic pharmaceuticals for the treatment of retinal diseases, announces today that it will report first quarter 2021 financial results on Wednesday, April 28, 2021 after the market close.
Management will host a conference call at 9:00 AM ET on Thursday, April 29, 2021 to review financial results and provide an update on corporate developments. Following management's formal remarks, there will be a question and answer session.
Participants are asked to pre-register for the call.
Please note that registered participants will receive their dial-in number upon registration and will dial directly into the call without delay. Those without Internet access or who are unable to pre-register may dial in by calling 1-844-839-2190 (domestic) or 1-412-717-9583 (international). All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the Alimera Sciences call.
The conference call will also be available through a live webcast, which is also available through the company's website.
A webcast replay of the call will be available approximately one hour after the end of the call through July 29, 2021. The webcast replay can be accessed through the above links or by calling 1-877-344-7529 (domestic) or 1-412-317-0088 (international) and using access code 10155027. The telephonic replay will be available until May 13, 2021.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: For investor inquiries: Jules Abraham Scott Gordon for Alimera Sciences for Alimera Sciences 917-885-7378 [email protected] [email protected] -
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- Alimera grants exclusive license to Ocumension for a $10 million upfront payment and up to $89 million in additional sales-based milestone payments
- Ocumension makes a $10 million equity investment in Alimera
ATLANTA, April 14, 2021 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (NASDAQ:ALIM) (Alimera), a pharmaceutical company that specializes in the development and commercialization of prescription ophthalmic pharmaceuticals, announced today that Ocumension Therapeutics (Ocumension), a company focused on developing and commercializing innovative ophthalmology therapies in China and Asia, has acquired an exclusive license agreement for Alimera's 0.19mg fluocinolone acetonide intravitreal implant, which Alimera markets elsewhere under the trademark ILUVIEN®. The license grants Ocumension the rights to develop and commercialize the product for the treatment of diabetic macular edema and other retina diseases (excluding uveitis) in the Greater China territory and other Western Pacific countries under Ocumension's own distinct trademark. Additionally, Ocumension has made a $10 million equity investment in Alimera via a private offering.
Under the terms of the exclusive license agreement, Alimera may receive a total of up to $99 million, including an upfront payment of $10 million and a potential $89 million in sales-based milestone payments. In exchange, Ocumension will receive exclusive rights to develop and commercialize the product under its own branded label in Mainland China, Hong Kong SAR, Macau SAR, Taiwan District, South Korea, Brunei, Cambodia, East Timor, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam. Alimera will also be the exclusive supplier of product to Ocumension for commercial sale at an agreed upon transfer price.
"We are excited about this opportunity with Ocumension to continue our strategy of geographic expansion. Diabetes and its complications are a growing issue, with a third of the total number of people with diabetes living in the Western Pacific1. We look forward to working with Ocumension to help patients suffering from diabetic macular edema in these markets to see better, longer, with fewer injections," said Rick Eiswirth, Alimera's President and Chief Executive Officer. "Additionally, the initial license fee combined with Ocumension's equity investment significantly strengthens our balance sheet and provides incremental financing to pursue our vision of creating a unique global company solely focused on retina specialists and their patients."
"Our agreement with Alimera allows us to expand our ophthalmology product portfolio with another best-in-class, unique and proven ophthalmic therapy to address the unmet need of durable therapy in the treatment of diabetic macular edema," said Ye Liu, Chief Executive Officer of Ocumension.
Under the terms of a share purchase agreement, Ocumension has purchased 1,144,945 shares of Alimera's common stock at a price of approximately $8.73 per share, or $10 million in total.
Ocumension has agreed to issue to Alimera 1,000,000 non-transferable warrants granting Alimera the right for a period of four years to subscribe to up to an aggregate of 1,000,000 shares of Ocumension stock at the subscription price of HK$23.88 per warrant share (or approximately US$3.07 per warrant share converted to U.S. Dollars at the April 9, 2021 exchange rate of .12853 U.S. Dollars per HK$), subject to adjustment. The issuance of the warrants to Alimera is subject to certain conditions precedent.
For more details on the terms of the Ocumension transactions, please see Alimera's Current Report on Form 8-K, which Alimera expects to file with the SEC promptly after issuing this press release.
1 Data from the International Diabetes Federation, Diabetes Atlas 9th edition, prevalence of diabetes (20-79 years), 2019.
About ILUVIEN
The Company's sole 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 and number of treatments required, 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, Czech Republic, the Netherlands, and Luxembourg. The Company is selling ILUVIEN with the non-infectious posterior uveitis indication in Germany, the U.K., the Netherlands and Finland and is pursuing reimbursement for the remaining countries. 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 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 Ocumension Therapeutics
Ocumension Therapeutics is a China-based ophthalmic pharmaceutical platform company dedicated to identifying, developing and commercializing first- or best-in-class ophthalmic therapies. The company's vision is to provide a world-class pharmaceutical total solution to address significant unmet ophthalmic medical needs in China. Since its inception, Ocumension Therapeutics has focused on building a platform integrating specialized capabilities in each major functionality involved in an ophthalmic drug's development cycle, from research and development, manufacturing to commercialization. Ocumension Therapeutics believes its platform positions it well to achieve leadership in China ophthalmology, with a first-mover advantage over future competitors.
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 its relationship with Ocumension. 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, Ocumension's ability to satisfy the regulatory requirements to be able to sell the licensed product in the countries and jurisdictions within the license territory and to successfully commercialize the product in those countries and jurisdictions.
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 Alimera press inquiries:
Jules Abraham
for Alimera Sciences
917-885-7378
[email protected]For Alimera investor inquiries:
Scott Gordon
for Alimera Sciences
[email protected]Ocumension Contact:
Qinglei Zuo
+86-21-68362137-7796
[email protected] -
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ATLANTA, March 18, 2021 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (NASDAQ:ALIM) ("Alimera"), a pharmaceutical company that specializes in the commercialization and development of prescription ophthalmology treatments for the management of retinal diseases, announced today that President and CEO Rick Eiswirth will participate in the Benzinga Biotech Small Cap Conference to be held March 24-25, 2021.
Mr. Eiswirth will present on March 25 at 12:00 pm ET.
Investors can view Mr. Eiswirth's general corporate presentation once they register for the conference here and can also request a 1x1 meeting with Mr. Eiswirth.
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] -
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ATLANTA, March 17, 2021 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (NASDAQ:ALIM) ("Alimera"), a pharmaceutical company that specializes in the commercialization and development of prescription ophthalmology treatments for the management of retinal diseases, announces continued execution on its geographic expansion strategy with publication of ILUVIEN pricing in Denmark and Luxembourg. In addition, the Company received approval for reimbursement for the prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) from the three largest private health insurers in Ireland.
"Alimera continues to make incremental progress on our global expansion strategy, regularly receiving approval for distribution and reimbursement by the regulatory authorities in new countries, despite the fact that we continue to feel the effects of the global pandemic of COVID-19," stated Rick Eiswirth, Alimera's President and CEO. "While the health status may vary country by country, presenting challenges to those doctors trying to prescribe ILUVIEN to their patients, we continue to receive the consistent message from both the healthcare professionals and the regulatory authorities reviewing our applications that ILUVIEN has a measurable impact on patients."
In March, the price of ILUVIEN was made public in Denmark where ILUVIEN is approved for both the DME and NIU-PS indications. Earlier in the quarter, Luxembourg's Ministry of Health approved ILUVIEN for reimbursement for DME. In Ireland, the three largest private insurers, which together represent approximately 50% of covered lives in the country, also recently approved ILUVIEN for reimbursement in private hospitals under its health plans. The Company is still waiting for the public health system to grant reimbursement.
About ILUVIEN
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg sustained release intravitreal implant that is 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 and number of treatments required, 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 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 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, regarding, among other things, Alimera's expectations with respect to continued geographic expansion. 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, Alimera's ability to successfully commercialize ILUVIEN in Denmark, Luxembourg and Ireland and the general acceptance by patients and physicians of ILUVIEN to treat NIU-PS in Denmark, Luxembourg and Ireland, as well as other factors discussed in the "Summary of Principal Risk Factors," "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, 2020 which is 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]