About Alimera Sciences

Alimera Sciences, Inc. and its subsidiaries (Alimera Sciences) operate as a commercial-stage global pharmaceutical company. The company engages in developing and commercializing ILUVIEN for the treatment of diabetic macular edema (DME), a leading cause of blindness, and outside the U.S. for non-infectious uveitis affecting the posterior segment of the eye (NIU-PS). ILUVIEN is a state-of-the-art, sustained release intravitreal implant that enables patients to maintain vision longer, and importantly, with fewer injections. The company commercializes ILUVIEN in the U.S., Europe, China and Middle East. The company is also studying ILUVIEN in a clinical trial, the NEW DAY Study, where it is being evaluated for efficacy as baseline therapy in patients with early DME by comparing ILUVIEN to the current standard of care, anti-vascular endothelial growth factor (VEGF) therapy. Alimera’s mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer. Business Strategy The company focuses on diseases affecting the back of the eye, or retina, because these diseases are not sufficiently treated with competing therapies and treatment regimens and represent a significant market opportunity. The company’s strategy is to establish ILUVIEN as a leading therapy for DME and NIU-PS patients for which ILUVIEN is proven safe and effective because of its ability to help patients see better, longer with fewer injections for up to three years. To implement the company’s strategy, the company intends to maximize the commercial success of ILUVIEN for the treatment of DME in the U.S., Europe, and the Middle East where the company has obtained regulatory approval; maximize the commercial success of ILUVIEN for the treatment of NIU-PS in Europe where the company has obtained regulatory approval; continue to pursue approval for ILUVIEN for DME and NIU-PS in additional countries; and expand the company’s ophthalmic product offerings. ILUVIEN The company’s only commercial product is ILUVIEN, an intravitreal implant that treats patients by delivering a continuous microdose of the corticosteroid fluocinolone acetonide (FAc) in the eye, for up to 36 months. ‘Intravitreal’ refers to the space inside the eye behind the lens that contains the jelly-like substance called vitreous. ILUVIEN was initially developed to treat DME, a disease of the retina that affects individuals with Type 1 or Type 2 diabetes and can lead to severe vision loss and blindness. ILUVIEN is also used in certain countries in the European Economic Area (EEA) to prevent relapse in recurrent NIU-PS. Uveitis is an inflammatory disease of the uveal tract, which included the iris, ciliary body and choroid, that can lead to severe vision loss and blindness. ILUVIEN is inserted into the back of the patient’s eye in a non-surgical procedure employing a device with a 25-gauge needle, which allows for a self-sealing wound. Corticosteroids provide the best option in the treatment of DME and NIU-PS because they reduce the inflammatory aspects of the disease. Further, ILUVIEN’s CONTINUOUS MICRODOSING delivery makes it the only approved drug therapy for DME that can deliver consistent daily therapeutic levels of corticosteroid and reduce the recurrence of DME and uveitis. The delivery mechanism of ILUVIEN provides lower daily and aggregate exposure to corticosteroids than any other intraocular dosage forms available, which mitigates the typical risks associated with corticosteroid therapy. Further, the ILUVIEN implant, which is non-bioerodible, provides consistent delivery as a result of its constant surface area, permitting elution of FAc to the vitreous. This provides a sustained therapeutic effect on DME and NIU-PS. Other therapies that physicians use to treat DME, such as anti-VEGF treatments and other corticosteroids, are acute (short-acting) therapies that provide a higher initial daily dose but then rapidly decline, requiring frequent reinjection by the physician to maintain an effective dose or reestablish the therapeutic effect after the disease has recurred. The active compound in ILUVIEN is FAc, a non-proprietary corticosteroid. ILUVIEN delivers continuous daily sub-microgram levels of FAc in both in vitro and in vivo release kinetic studies for up to 36 months, making it the only single injection therapy available to treat the retina consistently every day for up to three years, allowing patients to see better, longer with fewer injections. Corticosteroids, including FAc, have demonstrated a range of pharmacological actions, including the inhibition of inflammation, the inhibition of leukostasis, up regulation of occludin, inhibition of the release of certain inflammatory cytokines and suppression of VEGF secretion. Leukostasis refers to the accumulation of white blood cells at a particular site, which leads to further tissue damage. Occludin is an important protein in maintaining and reinforcing the tight junctions between cells. These pharmacological actions have the potential to treat various ocular conditions, including DME, NIU-PS, Non-Proliferative Diabetic Retinopathy (NPDR), retinal vein occlusion (RVO), dry age-related macular degeneration (AMD) and wet AMD. However, FAc shares many of the same ‘class effect’ side effects seen with other corticosteroids that are available for intraocular use. The two main side effects of using corticosteroids to treat ocular conditions are increased intraocular pressure, which may increase the risk of glaucoma, and the acceleration of cataract formation. FAc is uniquely lipophilic, making it very effective at penetrating retina tissue, and allowing it to achieve a therapeutic effect at a very low dose, typically lower than other corticosteroids. In order to mitigate these side effects, ILUVIEN is designed to deliver significantly lower daily exposure than any other available corticosteroid dosage form while maintaining a therapeutic effect. Additionally, as demonstrated with real-world evidence, the side effects of ILUVIEN are consistent with and predictable following the use of shorter duration or acute corticosteroid therapies, increasing the physician’s ability to manage those side effects. NEW DAY Study ILUVIEN continues to be underutilized in the treatment of DME and should be used much earlier in patients suffering from DME. The company’s prior clinical data sets demonstrate the ability of ILUVIEN to control the underlying disease process and reduce the recurrence of edema for up to three years, rather than treating recurrent chronic edema with short-term therapies. With the NEW DAY Study, the company intends to demonstrate the efficacy of ILUVIEN as baseline therapy in patients with early DME by comparing ILUVIEN to the standard of care, anti-VEGF therapy. In July 2020, the company announced the initiation of its NEW DAY clinical trial, a multicenter, single masked, randomized and controlled trial designed to generate prospective data evaluating ILUVIEN as a baseline therapy in the treatment of DME and demonstrate its advantages over using the current standard of care of repeat anti-VEGF injections. The NEW DAY Study is planned to enroll approximately 300 treatment-naïve, or almost naïve, DME patients in approximately 40 sites around the U.S. As of February 28, 2023, the company has enrolled 261 DME patients. The company expects to complete enrollment in the NEW DAY Study in the first half of 2023. Patients who meet the entry criteria will be randomized to receive either an ILUVIEN intravitreal implant or five injections of intravitreal aflibercept 2 mg at four-week intervals for the first 16 weeks as a loading dose. After the initial 16-week period, both treatment arms will be evaluated every four weeks and receive supplemental intravitreal injections of aflibercept 2 mg only as needed. Criteria for supplemental treatment is set by protocol and will be identical in both treatment arms. The planned treatment period in the study is 18 months. Once the treatment period is concluded, patients will be given the option to participate in an open label extension study for up to 42 months. The primary outcome measure for the NEW DAY Study is the mean number of supplemental aflibercept injections needed during the trial between treatment groups. Key secondary endpoints include mean best corrected visual acuity (BCVA) score over time up to 18 months, time to first supplemental treatment, retinal thickness amplitude on optical coherence tomography (OCT), and diabetic retinopathy scores. In addition, the trial will collect patient-reported outcome measures to evaluate the effect on patients’ quality of life and level of functioning. Exploratory endpoints will include neuronal functional measures and OCT imaging measures of retinal nerve layer thickness. The company commercially markets ILUVIEN directly in the U.S., Germany, the U.K., Portugal, and Ireland. The company has entered into various agreements under which distributors are providing or will provide regulatory, reimbursement or sales and marketing support for ILUVIEN in Austria, Belgium, the Czech Republic, Denmark, Finland, France, Italy, Luxembourg, the Netherlands, Norway, Spain, Sweden, Switzerland, Australia, New Zealand, China and several countries in the Western Pacific and several countries in the Middle East. As of December 31, 2022, the company has recognized net product revenue from the company’s international distributors in the Middle East, China, Austria, Belgium, the Czech Republic, France, Italy, Luxembourg, Spain and the Netherlands. ILUVIEN for Other Diseases of the Eye Although the company is not actively conducting clinical trials for a new indication, ILUVIEN has the potential to address other ophthalmic diseases such as RVO, NPDR, dry AMD and wet AMD. Sales and Marketing The company’s sales personnel focus on physician offices, clinics, pharmacies and hospitals in the U.S. and in European countries where the company seeks to persuade end users to purchase ILUVIEN. In the company’s promotional efforts, the company focuses on three main areas to generate demand for ILUVIEN. The first is to gain access for ILUVIEN on formularies, contracts and through national and local health care authorities to achieve a reasonable price in the countries in which the company intends to commercialize. Second is to educate physicians on the efficacy and safety of ILUVIEN through direct promotion, advocacy building and indirect marketing activities. Third is to enable patients and caregivers in markets where it is permitted to become more educated on their disease and the possible treatments. Distributor Agreements The company has various agreements under which distributors are providing or will provide regulatory, reimbursement or sales and marketing support for commercialization of ILUVIEN in Austria, Belgium, Czech Republic, Denmark, Finland, France, Italy, Luxembourg, the Netherlands, Norway, Spain, Sweden, Switzerland, Australia and New Zealand, China and other countries of the Western Pacific and in the Middle East. Pursuant to these agreements, the company’s distributors assisted or will assist the company in obtaining and maintaining approval and reimbursement approval, or they will seek approval or reimbursement approval with its oversight in those countries, if such approval or reimbursement approval has not already been obtained. Manufacturing The company has agreements with a single third-party manufacturer for each of the following: The manufacture of FAc, ILUVIEN’s active pharmaceutical ingredient (FARMABIOS SpA/Byron Chemical Company Inc.); The manufacture of the components of the ILUVIEN applicator (Cadence, Inc. (Cadence)); The manufacture of the ILUVIEN implant, final assembly of the injector with the implant and release testing in the U.S. (Alliance); The quality release testing of ILUVIEN (Alliance); Final product release to market in the EEA (carried out in Ireland by Packaging Coordinators, Inc.); and Final product release to market in the U.K. (carried out in Ireland by Packaging Coordinators, Inc.). Under the company’s agreement with Alliance, the company is responsible for supplying Alliance with the ILUVIEN applicator and the API. Business Segments The company’s operations are now managed as three operating segments: U.S., International and Operating Cost. Customers The company’s revenues for the year ended December 31, 2022 were generated from product sales primarily in the U.S., Germany, France and the U.K. In the U.S., two large pharmaceutical distributors accounted for 63% of the company’s consolidated product revenues for the year ended December 31, 2022. These distributors maintain inventories of ILUVIEN and sell to physician offices, pharmacies and hospitals. Internationally, in countries where the company sells direct, its customers are hospitals, clinics and pharmacies. The company sometimes refers to physician offices, pharmacies, hospitals and clinics as end users. In international countries where the company sells to distributors, these distributors maintain inventory levels of ILUVIEN and sell to their customers. Licenses and Agreements EyePoint Pharmaceuticals US, Inc. In 2005, the company entered into an agreement with EyePoint Pharmaceuticals US, Inc. (EyePoint), for the use of FAc in EyePoint’s proprietary insert technology which was amended and restated in July 2017 (the New Collaboration Agreement). The New Collaboration Agreement provides the company with a license to utilize certain underlying technology used in the development and commercialization of ILUVIEN. Pursuant to the New Collaboration Agreement, the company holds a worldwide license from EyePoint for the use of steroids, including FAc, in EyePoint’s proprietary insert technology for the treatment of all ocular diseases, other than uveitis outside of Europe, the Middle East and Africa. The New Collaboration Agreement provides the company with a license to develop and sell EyePoint’s proprietary insert technology to deliver other corticosteroids to the back of the eye for the treatment and prevention of eye diseases in humans or to treat DME by delivering a compound to the back of the eye through a direct delivery method through an incision required for a 25-gauge or larger needle. Ocumension License Agreement On April 14, 2021, the company entered into an exclusive license agreement (the License Agreement) with Ocumension (Hong Kong) Limited, a wholly owned subsidiary of Ocumension Therapeutics (Ocumension), for the development and commercialization under Ocumension’s own distinct trademark, of the company’s 190 microgram FAc intravitreal implant (the Product, which is marketed elsewhere as ILUVIEN) for the treatment and prevention of eye diseases in humans, other than uveitis, in China and other Western Pacific countries. Government Regulation The manufacturing facility that produces the company’s product, as well as the company’s corporate headquarters facility, must maintain compliance with the FDA’s current Good Manufacturing Practices (cGMP) and are subject to periodic inspections by the FDA. Patents and Proprietary Rights The term ‘ILUVIEN’ is the company’s registered trademark. As of December 31, 2022, the company owned or licensed two U.S. utility patents and one U.S. design patent, as well as numerous foreign counterparts to many of these patents and patent applications relating to ILUVIEN or the ILUVIEN applicator. The company licensed its one utility patent right relating to ILUVIEN from EyePoint. Pursuant to the New Collaboration Agreement with EyePoint, the company’s ILUVIEN-related patent rights are only for diseases of the human eye in Europe, the Middle East and Africa, and for diseases of the human eye excluding uveitis in the rest of the world. In addition to the U.S. patents licensed from EyePoint, the company also licenses two European patents from EyePoint. The company has a U.S. utility patent directed to the company’s applicator system for ILUVIEN. The company’s licensed patent portfolio includes U.S. patents (with no currently pending or issued corresponding European applications or patents) with claims directed to methods for administering a corticosteroid with an implantable sustained delivery device to deliver the corticosteroid to the vitreous of the eye wherein aqueous corticosteroid concentration is less than vitreous corticosteroid concentration during release. The U.S. utility patents generally have a term of 20 years from the date of filing. The utility patent rights relating to ILUVIEN that EyePoint licensed to the company includes one U.S. patent that will expire August 2027, two European patents that are directed to the company’s low-dose device that expired in April 2021 and will expire in October 2024, respectively, and counterpart filings to these patents in a number of other jurisdictions. Research and Development The company invested $5.4 million in research and development during 2022. History Alimera Sciences, Inc., a Delaware corporation, was founded in 2003. The company was incorporated in 2003.