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. 02, 2021 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (NASDAQ:ALIM) ("Alimera"), Alimera Sciences, Inc. (NASDAQ:ALIM) ("Alimera"), a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer., announces today that Chief Executive Officer Rick Eiswirth will present at the 23rd Annual H.C. Wainwright Global Investment Conference which is being held virtually from September 13 – 15, 2021.
Mr. Eiswirth will deliver his corporate presentation, which will become available beginning on September 13 at 7:00 AM ET.
David Holland, Chief Marketing Officer and Philip Ashman, Chief Operating Officer will be available for one-on-one meetings throughout the conference.
Investors can register here: www.hcwevents.com.
About Alimera Sciences, Inc.
Alimera Sciences a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer. 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 scottg@coreir.com julesa@coreir.com
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ATLANTA, Aug. 24, 2021 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (NASDAQ:ALIM) (Alimera), a pharmaceutical company that specializes in the commercialization and development of prescription ophthalmic pharmaceuticals, announces that Alimera Sciences Europe Limited, its Ireland-based European subsidiary, received pricing and reimbursement approval for ILUVIEN® for diabetic macular edema (DME) in Belgium from the National Institute for Health and Disability Insurance (INAMI). Pricing and reimbursement approval was sought and secured by Alimera's distribution partner in France and the Benelux region, Horus Pharma S.A.S. (Horus). Horus is currently in the launch phase in Belgium.
"The continued expansion of ILUVIEN availability throughout Europe further represents the execution of our international growth strategy," said Rick Eiswirth, President and Chief Executive Officer of Alimera. "We anticipate this will fuel even more growth for ILUVIEN in the Benelux region behind the strength of the Horus team."
ILUVIEN is a sustained release intravitreal implant indicated in Europe for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies and for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIPU).
About ILUVIEN
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a 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 up to 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 (NIU-PS). 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 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.
Forward Looking Statements
This press release may contain "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 the growth of ILUVIEN sales in the Benelux region. 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. These factors include the ability of Alimera's distributor Horus Pharma S.A.S. to effectively market ILUVIEN and the willingness of physicians, patients and payers to adopt ILUVIEN.
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
julesa@coreir.comFor investor inquiries:
Scott Gordon
for Alimera Sciences
scottg@coreir.com
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- Consolidated Net Revenue of $21.7 Million up 117% vs. Second Quarter of 2020
- Consolidated Net Product Revenue of $10.7 Million up 7% vs. Second Quarter of 2020
- Net Income of $7.6 Million vs. Net Loss of $2.5 Million in Second Quarter of 2020
- End User Demand up 16% on a Same Country Basis vs. Second Quarter of 2020
ATLANTA, Aug. 13, 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 second quarter of 2021. Alimera will host a conference call today at 9:00 a.m. EDT to discuss these results.
"Although the ongoing COVID-19 pandemic continues to impact the delivery of healthcare around the world and has adversely affected our overall results, we are pleased to see a return to net growth in end user demand of 16% in second quarter 2021 in the U.S. and the seven European markets where we were selling in the second quarter of 2020," said Rick Eiswirth, Alimera's President and Chief Executive Officer. "During the quarter we also announced our transaction with Ocumension Therapeutics, which generated significant license revenue and equity capital. The Ocumension transaction also advances our goal of expanding ILUVIEN availability in the Greater China territory and other Western Pacific countries and strengthens our balance sheet for future investments behind ILUVIEN. Additionally, we added Dr. David Dyer to our management team as our new Chief Retina Specialist, to increase key opinion leader engagement and advocacy development."
Second Quarter 2021 Financial Results
Net Revenue
Consolidated net revenue increased 117% to approximately $21.7 million, compared to $10.0 million for Q2 2020. Consolidated net revenue was composed of $10.7 million of consolidated net product revenue and $11.0 million in license revenue from the Ocumension transaction.U.S. net product revenue increased 71% to approximately $5.8 million for Q2 2021 compared to $3.4 million for Q2 2020. The increase was primarily due to increased patient access to physicians. End user demand, which represents units purchased by physicians and pharmacies from our distributors, increased 17% to 731 units during Q2 2021 compared to 625 units during Q2 2020. We had no licensing revenue in the U.S. in the second quarter of 2021 or of 2020.
The difference between the growth in GAAP revenue and the growth in end user demand is due to the timing of U.S. distributor purchases in Q2 2021 versus Q2 2020. During Q2 2021, our distributors purchased approximately the same number of units they sold to end users, while in Q2 2020 our U.S. distributors purchased 36% fewer units than they sold in order to reduce inventory during the pandemic.
International net revenue increased 141% to approximately $15.9 million for Q2 2021, compared to approximately $6.6 million for Q2 2020. International net revenue was composed of $4.9 million of net product revenue and $11.0 million in license revenue generated from the Ocumension transaction.
International product revenue was down 26% to approximately $4.9 million compared to $6.6 million for Q2 2020. The decrease in product revenue was driven by (a) a lack of orders from our distributor partners, which continued to sell off inventory acquired in 2020 and (b) a significant decrease in end user demand in Germany in Q2 2021 compared to Q2 2020 due to restricted access to healthcare facilities as a result of a substantial rise in the number of reported COVID cases over the quarter in comparison to the prior year. The decrease in product revenue was partially offset by the acceleration of $1.0 million in deferred product revenue associated with the termination of our Canadian distribution agreement with Knight Therapeutics. Across our seven European markets where we were selling in Q2 2020 – the United Kingdom, Germany, Portugal, France, Italy, Spain and Ireland – net end user demand grew from 824 units in the second quarter of 2020 to 955 units in the second quarter of 2021, a net increase of 16% despite the challenges in Germany. Markets where ILUVIEN has been recently made available are not included in the end user calculation for comparison purposes.
International license revenue was approximately $11.0 million in Q2 2021 compared to no revenue in Q2 2020. The license revenue in Q2 2021 was generated from a non-refundable upfront payment of $10.0 million from Ocumension (Hong Kong) Limited under an exclusive license agreement combined with the value of a warrant subscription agreement received as consideration in the Ocumension transaction for Alimera to purchase 1,000,000 shares of Ocumension Therapeutics during a period of four years. Alimera recognized $11.0 million in license revenue from the Ocumension transaction in accordance with Accounting Standards Codification (ASC) 606, Revenue from Contracts with Customers, with the remaining approximate $300,000 in consideration classified as deferred revenue that will be recognized over the remaining term of the license agreement once Ocumension begins to sell products. For more information regarding the Ocumension transaction, see our Current Report on Form 8-K filed with the SEC on April 14, 2021.
Operating Expenses
Total operating expenses were approximately $12.9 million for Q2 2021, compared to approximately $9.9 million for Q2 2020. In Q2 2020 the Company aggressively managed its expenses during the emergence of the pandemic. In Q2 2021, the Company returned to a more normalized spending pattern as access to physician practices and hospitals began to improve.Net Income (Loss) and Adjusted EBITDA
Net income for Q2 2021 was $7.6 million, compared to a net loss of approximately $(2.5) million for Q2 2020. "Adjusted EBITDA," a non-GAAP financial measure defined below, was approximately $7.9 million for Q2 2021, compared to Adjusted EBITDA of approximately $(0.3) million for Q2 2020. Adjusted EBITDA for Q2 2021 includes the impact of $11.0 million in license revenue from the Ocumension transaction and the acceleration of $1.0 million in deferred product revenue associated with the termination of our Canadian distribution agreement with Knight Therapeutics.Net Income (Loss) per Share
Basic and diluted net income per share for Q2 2021 was approximately $1.03 compared to basic and diluted net loss per share of $(0.51) for Q2 2020.Cash and Cash Equivalents
On June 30, 2021, Alimera had cash and cash equivalents of approximately $24.8 million, compared to $8.3 million in cash and cash equivalents on March 31, 2021. This compares to $11.2 million of cash and cash equivalents on hand at December 31, 2020.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, severance expenses and change in fair value of warrant asset. 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 Today
A live conference call will be hosted today August 13, 2021, at 9:00 a.m. EDT 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: Friday, August 13, 2021, 9:00 a.m. EDT
Conference dial-in: 844-839-2190
International dial-in: 412-317-9583
Conference Call Name: Alimera Sciences (NASDAQ:ALIM) Second 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/10158209/ea8977315cPlease 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/mediaframe/webcast.html?webcastid=cMCGw90M
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: 10158029
End Date: August 27, 2021
Webcast Replay End Date: November 12, 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 and six months ended June 30, 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. Consistent with our prior practice when we had a warrant asset with a value that was subject to quarterly revision and with how we use Adjusted EBITDA in the management of our business, we have added change in fair value of warrant asset as an adjustment in the calculation of 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 belief that the strengthened balance sheet will lead to future investments behind ILUVIEN and that the Company will be able to increase key opinion leader engagement and advocacy development through the hiring of Dr. David Dyer. 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 parts of both Europe and the U.S.; (d) the emergence of COVID-19 variants that increase the transmissibility of the coronavirus and are more deadly; (e) the success or failure of the vaccine campaigns in Alimera's markets; (f) the timing of when the pandemic will subside enough to permit Alimera's operations to return to its prior growth trajectory, particularly in the U.S. and Germany, 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 second 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 Jules Abraham for Alimera Sciences for Alimera Sciences scottg@coreir.com julesa@coreir.com
ALIMERA SCIENCES, INC.CONSOLIDATED BALANCE SHEETS
(in thousands)
June 30, December 31, 2021 2020 (Unaudited) CURRENT ASSETS: Cash and cash equivalents $ 24,780 $ 11,208 Restricted cash 35 34 Accounts receivable, net 15,086 17,200 Prepaid expenses and other current assets 3,029 3,718 Inventory 2,307 2,746 Total current assets 45,237 34,906 NON-CURRENT ASSETS: Property and equipment, net 1,516 1,638 Right of use assets, net 683 720 Intangible asset, net 11,875 12,838 Deferred tax asset 729 753 Warrant asset 2,062 — TOTAL ASSETS $ 62,102 $ 50,855 CURRENT LIABILITIES: Accounts payable $ 7,083 $ 7,461 Accrued expenses 2,924 3,197 Paycheck Protection Program (PPP) loan — 1,481 Finance lease obligations 301 209 Total current liabilities 10,308 12,348 NON-CURRENT LIABILITIES: Notes payable, net of discount 42,595 42,408 Other non-current liabilities 3,308 4,077 COMMITMENTS AND CONTINGENCIES STOCKHOLDERS' EQUITY (DEFICIT): Preferred stock: Series A Convertible Preferred Stock 19,227 19,227 Common stock 69 57 Additional paid-in capital 376,334 365,830 Common stock warrants 370 370 Accumulated deficit (388,992 ) (392,909 ) Accumulated other comprehensive loss (1,117 ) (553 ) TOTAL STOCKHOLDERS' EQUITY (DEFICIT) 5,891 (7,978 ) TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) $ 62,102 $ 50,855 ALIMERA SCIENCES, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2021 AND 2020
(Unaudited)
Three Months Ended Six Months Ended June 30, June 30, 2021 2020 2021 2020 (In thousands, except share and per share data) REVENUES: PRODUCT REVENUE, NET $ 10,655 $ 10,038 $ 21,869 $ 24,573 LICENSE REVENUE 11,048 — 11,048 — NET REVENUE 21,703 10,038 32,917 24,573 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION (1,813 ) (1,485 ) (3,375 ) (3,412 ) GROSS PROFIT 19,890 8,553 29,542 21,161 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 3,567 1,810 6,780 4,693 GENERAL AND ADMINISTRATIVE EXPENSES 3,356 2,791 6,769 5,773 SALES AND MARKETING EXPENSES 5,331 4,566 10,149 10,437 DEPRECIATION AND AMORTIZATION 633 685 1,271 1,339 OPERATING EXPENSES 12,887 9,852 24,969 22,242 INCOME (LOSS) FROM OPERATIONS 7,003 (1,299 ) 4,573 (1,081 ) INTEREST EXPENSE AND OTHER (1,347 ) (1,351 ) (2,690 ) (2,643 ) UNREALIZED FOREIGN CURRENCY GAIN, NET 56 109 181 28 GAIN ON EXTINGUISHMENT OF DEBT 1,792 — 1,792 — CHANGE IN FAIR VALUE OF WARRANT ASSET 701 — 701 — NET INCOME (LOSS) BEFORE TAXES 8,205 (2,541 ) 4,557 (3,696 ) PROVISION FOR TAXES (640 ) (5 ) (640 ) (48 ) NET INCOME (LOSS) $ 7,565 $ (2,546 ) $ 3,917 $ (3,744 ) NET INCOME (LOSS) PER SHARE — Basic $ 1.03 $ (0.51 ) $ 0.57 $ (0.75 ) WEIGHTED AVERAGE SHARES OUTSTANDING — Basic 7,351,919 5,030,833 6,857,172 5,005,777 NET INCOME (LOSS) PER SHARE — Diluted $ 1.03 $ (0.51 ) $ 0.57 $ (0.75 ) WEIGHTED AVERAGE SHARES OUTSTANDING — Diluted 7,363,150 5,030,833 6,857,172 5,005,777 RECONCILIATION OF GAAP MEASURES TO NON-GAAP ADJUSTED MEASURES
GAAP NET INCOME OR LOSS TO NON-GAAP ADJUSTED EBITDA
(in thousands)
Three Months Ended
June 30,Six Months Ended
June 30,2021 2020 2021 2020 (unaudited) GAAP NET INCOME (LOSS) $ 7,565 $ (2,546 ) $ 3,917 $ (3,744 ) Adjustments to net income (loss): Interest expense and other 1,347 1,351 2,690 2,643 Provision for taxes 640 5 640 48 Depreciation and amortization 633 685 1,271 1,339 Stock-based compensation expenses 252 317 514 757 Unrealized foreign currency exchange (gains) losses (56 ) (109 ) (181 ) (28 ) Gain on extinguishment of debt (1,792 ) — (1,792 ) — Change in fair value of warrant asset (701 ) — (701 ) — Severance expenses — — 195 — NON-GAAP ADJUSTED EBITDA $ 7,888 $ (297 ) $ 6,553 $ 1,015 
- Consolidated Net Revenue of $21.7 Million up 117% vs. Second Quarter of 2020
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ATLANTA, Aug. 10, 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 second quarter 2021 financial results on Friday, August 13, 2021, prior to the market open.
Management will host a conference call at 9:00 AM ET on Friday, August 13, 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 November 12, 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 10158209. The telephonic replay will be available until August 27, 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 scottg@coreir.com julesa@coreir.com 
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ATLANTA, Aug. 09, 2021 (GLOBE NEWSWIRE) -- Alimera Sciences Europe Limited ("Alimera"), a wholly owned subsidiary of Alimera Sciences, Inc., and Tanner Pharma UK Limited ("Tanner") announced today the initiation of a Named Patient Program for ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg globally for the treatment of diabetic macular edema (DME) and in Europe and the Middle East, for the treatment of non-infectious posterior uveitis (NIU-PS).
The agreement names Tanner as the exclusive provider of ILUVIEN in specific countries outside of the United States on a named-patient basis where the product is not commercially available for patients with DME and NIU-PS.
"Alimera is excited to partner with Tanner to offer additional distribution of ILUVIEN to patients globally," said Rick Eiswirth, Alimera's President and Chief Executive Officer. "This program will potentially help support patients with diabetic macular edema and non-infectious posterior uveitis who would otherwise not have access to a long-term option and will continue Alimera's commitment to physicians and their patients with diseases of the retina."
"We are proud to work with Alimera to make ILUVIEN available to patients in countries where it is not commercially available," said Banks Bourne, Chairman and Founder of Tanner Pharma Group. "This partnership reflects the type of company and innovative product Tanner strives to offer."
About ILUVIEN
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a 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 up to 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 (NIU-PS). 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 Non-Infectious Posterior Uveitis (NIU-PS)
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 NIU-PS 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
Alimera Sciences, Inc., 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. Alimera Sciences Europe Limited is the company's Irish subsidiary. For more information, please visit www.alimerasciences.com.
About Tanner Pharma Group
Tanner Pharma Group is a specialist pharmaceutical services provider based in Charlotte, USA with offices in Europe and Latin America. Over 18 years, Tanner has developed a portfolio of service offerings focused on improving the global access to medicines. Through its TannerMAP division, Tanner supports manufacturers by providing ethical, controlled and compliant access to their innovative medicines in countries where they are not commercially accessible. For more information, visit www.tannerpharma.com
Forward Looking Statements
This press release may contain "forward-looking statements," within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, Alimera's intent to offer additional distribution of ILUVIEN to patients globally and the potential to help support patients with diabetic macular edema and non-infectious posterior uveitis who would otherwise not have access to a long-term option. 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.
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
julesa@coreir.com
Tanner Pharma Group
E-mail: iluvien@tannerpharma.com
Phone: +44 (0) 20 39408 111 (UK)
+1 704 552 8408 (USA)For investor inquiries:
Scott Gordon
for Alimera Sciences
scottg@coreir.com