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Alimera (ALIM) Completes Enrollment in Eye Disease Study
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Alimera Sciences (ALIM - Free Report) announced the completion of patient enrollment in the NEW DAY study to evaluate the 0.19 mg dose strength of Iluvien as a baseline therapy in patients diagnosed with diabetic macular edema (“DME”).
The NEW DAY clinical study is evaluating Iluvien’s efficacy as baseline therapy in patients with early DME by comparing Iluvien with current standard-of-care, corticosteroid and anti-vascular endothelial growth factor (anti-VEGF) therapy, aflibercept.
Positive top-line results from the NEW DAY study are expected to be reported in early 2025. Management believes that the data readouts will support the effectiveness of Iluvien as a baseline treatment, offering patients a first-line treatment option that can maintain vision longer with fewer injections than other therapies.
Shares of Alimera rallied 8.1% on Wednesday, following the positive news. In the past year, shares of Alimera have plunged by 56.2% compared with the industry’s 5.2% decline.
Image Source: Zacks Investment Research
Alimera’s Iluvien received FDA approval in September 2014 for the treatment of DME in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. Currently, Iluvien is the only FDA-approved product in Alimera’s portfolio. Iluvien is an anti-VEGF therapy to treat DME in the United States and outside the United States for non-infectious uveitis affecting the posterior segment of the eye.
Management derives its confidence from the observations made in the post-hoc analyses from the PALADIN phase IV safety study of Iluvien 0.19 mg, which was announced in October 2022. The results from the PALADIN study indicated that the benefits of Iluvien are realized earlier when used early in DME treatment.
The NEW DAY study has currently enrolled approximately 300 treatment-naïve, or near naïve, DME patients in the United States. The study’s primary endpoint is the mean number of supplemental aflibercept injections needed during the trial between treatment groups.
Key secondary endpoints of the NEW DAY study include the mean best corrected visual acuity score over time, time to first supplemental treatment, measures of retinal thickness variability based on optical coherence tomography and diabetic retinopathy scores.
Current standard-of-care anti-VEGF therapies are marketed by big companies like Regeneron (REGN - Free Report) , Novartis (NVS - Free Report) and Roche (RHHBY - Free Report) , having commercially approved products for the treatment of retinal diseases like wet age-related macular degeneration (wet AMD), DME and retinal vein occlusion (RVO).
Regeneron’s Eylea (aflibercept) is a leader in the treatment of wet AMD, DME and macular edema following RVO which includes macular edema following central RVO and macular edema following branch RVO. The FDA also recently approved Eylea to treat preterm infants with retinopathy of prematurity.
Novartis’ Beovu is approved for the treatment of wet AMD. It is also currently approved in European Union (EU) for the same indication.
Last January, Roche’s Vabysmo was also approved by the FDA for the treatment of wet AMD and DME. Subsequently, Roche received approval for Vabysmo in the EU for the same indication in September 2022.
Image: Shutterstock
Alimera (ALIM) Completes Enrollment in Eye Disease Study
Alimera Sciences (ALIM - Free Report) announced the completion of patient enrollment in the NEW DAY study to evaluate the 0.19 mg dose strength of Iluvien as a baseline therapy in patients diagnosed with diabetic macular edema (“DME”).
The NEW DAY clinical study is evaluating Iluvien’s efficacy as baseline therapy in patients with early DME by comparing Iluvien with current standard-of-care, corticosteroid and anti-vascular endothelial growth factor (anti-VEGF) therapy, aflibercept.
Positive top-line results from the NEW DAY study are expected to be reported in early 2025. Management believes that the data readouts will support the effectiveness of Iluvien as a baseline treatment, offering patients a first-line treatment option that can maintain vision longer with fewer injections than other therapies.
Shares of Alimera rallied 8.1% on Wednesday, following the positive news. In the past year, shares of Alimera have plunged by 56.2% compared with the industry’s 5.2% decline.
Image Source: Zacks Investment Research
Alimera’s Iluvien received FDA approval in September 2014 for the treatment of DME in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. Currently, Iluvien is the only FDA-approved product in Alimera’s portfolio. Iluvien is an anti-VEGF therapy to treat DME in the United States and outside the United States for non-infectious uveitis affecting the posterior segment of the eye.
Management derives its confidence from the observations made in the post-hoc analyses from the PALADIN phase IV safety study of Iluvien 0.19 mg, which was announced in October 2022. The results from the PALADIN study indicated that the benefits of Iluvien are realized earlier when used early in DME treatment.
The NEW DAY study has currently enrolled approximately 300 treatment-naïve, or near naïve, DME patients in the United States. The study’s primary endpoint is the mean number of supplemental aflibercept injections needed during the trial between treatment groups.
Key secondary endpoints of the NEW DAY study include the mean best corrected visual acuity score over time, time to first supplemental treatment, measures of retinal thickness variability based on optical coherence tomography and diabetic retinopathy scores.
Current standard-of-care anti-VEGF therapies are marketed by big companies like Regeneron (REGN - Free Report) , Novartis (NVS - Free Report) and Roche (RHHBY - Free Report) , having commercially approved products for the treatment of retinal diseases like wet age-related macular degeneration (wet AMD), DME and retinal vein occlusion (RVO).
Regeneron’s Eylea (aflibercept) is a leader in the treatment of wet AMD, DME and macular edema following RVO which includes macular edema following central RVO and macular edema following branch RVO. The FDA also recently approved Eylea to treat preterm infants with retinopathy of prematurity.
Novartis’ Beovu is approved for the treatment of wet AMD. It is also currently approved in European Union (EU) for the same indication.
Last January, Roche’s Vabysmo was also approved by the FDA for the treatment of wet AMD and DME. Subsequently, Roche received approval for Vabysmo in the EU for the same indication in September 2022.
Alimera Sciences, Inc. Price and Consensus
Alimera Sciences, Inc. price-consensus-chart | Alimera Sciences, Inc. Quote
Zacks Ranks
Alimera currently carries a Zacks Rank #2 (Buy).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.