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KOD Begins Late-Stage Study of KSI-501 in Diabetic Macular Edema
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Key Takeaways
Kodiak initiated the global phase III ALTO study of KSI-501 in center-involved DME.
The study will compare KSI-501 with aflibercept in about 910 patients over approximately 96 weeks.
Kodiak is also testing KSI-501 in wet AMD, with DAYBREAK top-line data expected in September 2026.
Kodiak Sciences (KOD - Free Report) announced that it initiated a global late-stage ALTO study evaluating KSI-501 in patients with diabetic macular edema (DME). KSI-501 is an investigational bispecific therapy that targets IL-6 and VEGF for the treatment of retinal vascular diseases. Patient enrollment is ongoing.
DME is a complex, multi-factorial condition in which vascular leakage, disruption of the blood-retinal barrier, and chronic inflammatory signaling collectively contribute to retinal edema and vision loss.
Year to date, Kodiak's shares have risen 55.2% compared with the industry’s 6% growth.
Image Source: Zacks Investment Research
Key Highlights of Kodiak’s ALTO Study
The global, randomized, phase III ALTO study will evaluate the safety and efficacy of intravitreal KSI-501 5 mg versus Eylea (aflibercept) 2 mg in patients with center-involved DME. The study will enroll approximately 910 treatment-naïve or previously treated patients who will be randomized in a 5:3:5 ratio to three treatment arms. Following six monthly loading doses, patients will receive either KSI-501 every eight weeks with monthly assessments for individualized dosing, KSI-501 on an individualized schedule of every four to 24 weeks, or Eylea every eight weeks following five monthly loading doses.
The study will assess whether dual IL-6 and VEGF inhibition can provide greater visual improvements, better retinal fluid control and longer treatment durability, reducing the burden of frequent injections.
The primary endpoint is the mean change in best-corrected visual acuity from baseline. A key secondary endpoint will evaluate the proportion of patients achieving a two-step or greater improvement in the diabetic retinopathy severity scale at week 48. Additional measures will assess visual function, retinal anatomy, treatment burden, durability and safety.
Participants will be treated and followed for approximately 96 weeks, allowing the study to evaluate the efficacy and long-term durability of KSI-501.
Kodiak believes the combination of KSI-501's dual-pathway mechanism and its antibody biopolymer conjugate platform could provide deeper and more sustained disease control in DME patients, particularly those who remain inadequately controlled with anti-VEGF monotherapy.
More on KOD’s KSI-501
Besides DME, Kodiak is developing KSI-501 for the treatment of patients with wet age-related macular degeneration (wet AMD) in a separate late-stage study.
The company is evaluating KSI-501 as the first investigational arm in the phase III DAYBREAK study for wet AMD, with Zenkuda being the second investigational arm. The study has completed enrolling patients. The top-line data from both arms of the study are anticipated in September 2026.
Zenkuda is Kodiak’s lead investigational candidate being evaluated across three different retinal vascular and exudative diseases, such as wet AMD, retinal vein occlusion and non-proliferative diabetic retinopathy.
Over the past 60 days, earnings per share estimates for Amneal Pharmaceuticals have increased from $1.00 to $1.02 for 2026. Over the same period, estimates for earnings per share increased from $1.12 to $1.21 for 2027. AMRX shares have risen 41.9% year to date.
Amneal Pharmaceuticals beat earnings in the trailing four quarters, delivering an average surprise of 32.82%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have increased to $3.02 from $2.97. Over the same period, EPS estimates for 2027 have risen to $5.31 from $4.81. LQDA shares have gained 163.9% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 54.40%.
Over the past 60 days, estimates for Altimmune’s 2026 loss per share have narrowed from 69 cents to 64 cents. Over the same period, loss estimates for 2027 have also improved from 73 cents to 64 cents. ALT shares have declined 15.6% year to date.
Altimmune’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 15.81%.
View the Zacks #1 Rank List
Image: Bigstock
KOD Begins Late-Stage Study of KSI-501 in Diabetic Macular Edema
Key Takeaways
Kodiak Sciences (KOD - Free Report) announced that it initiated a global late-stage ALTO study evaluating KSI-501 in patients with diabetic macular edema (DME). KSI-501 is an investigational bispecific therapy that targets IL-6 and VEGF for the treatment of retinal vascular diseases. Patient enrollment is ongoing.
DME is a complex, multi-factorial condition in which vascular leakage, disruption of the blood-retinal barrier, and chronic inflammatory signaling collectively contribute to retinal edema and vision loss.
Year to date, Kodiak's shares have risen 55.2% compared with the industry’s 6% growth.
Image Source: Zacks Investment Research
Key Highlights of Kodiak’s ALTO Study
The global, randomized, phase III ALTO study will evaluate the safety and efficacy of intravitreal KSI-501 5 mg versus Eylea (aflibercept) 2 mg in patients with center-involved DME. The study will enroll approximately 910 treatment-naïve or previously treated patients who will be randomized in a 5:3:5 ratio to three treatment arms. Following six monthly loading doses, patients will receive either KSI-501 every eight weeks with monthly assessments for individualized dosing, KSI-501 on an individualized schedule of every four to 24 weeks, or Eylea every eight weeks following five monthly loading doses.
The study will assess whether dual IL-6 and VEGF inhibition can provide greater visual improvements, better retinal fluid control and longer treatment durability, reducing the burden of frequent injections.
The primary endpoint is the mean change in best-corrected visual acuity from baseline. A key secondary endpoint will evaluate the proportion of patients achieving a two-step or greater improvement in the diabetic retinopathy severity scale at week 48. Additional measures will assess visual function, retinal anatomy, treatment burden, durability and safety.
Participants will be treated and followed for approximately 96 weeks, allowing the study to evaluate the efficacy and long-term durability of KSI-501.
Kodiak believes the combination of KSI-501's dual-pathway mechanism and its antibody biopolymer conjugate platform could provide deeper and more sustained disease control in DME patients, particularly those who remain inadequately controlled with anti-VEGF monotherapy.
More on KOD’s KSI-501
Besides DME, Kodiak is developing KSI-501 for the treatment of patients with wet age-related macular degeneration (wet AMD) in a separate late-stage study.
The company is evaluating KSI-501 as the first investigational arm in the phase III DAYBREAK study for wet AMD, with Zenkuda being the second investigational arm. The study has completed enrolling patients. The top-line data from both arms of the study are anticipated in September 2026.
Zenkuda is Kodiak’s lead investigational candidate being evaluated across three different retinal vascular and exudative diseases, such as wet AMD, retinal vein occlusion and non-proliferative diabetic retinopathy.
KOD's Zacks Rank & Stocks to Consider
Kodiak currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are Amneal Pharmaceuticals (AMRX - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy), and Altimmune (ALT - Free Report) , which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, earnings per share estimates for Amneal Pharmaceuticals have increased from $1.00 to $1.02 for 2026. Over the same period, estimates for earnings per share increased from $1.12 to $1.21 for 2027. AMRX shares have risen 41.9% year to date.
Amneal Pharmaceuticals beat earnings in the trailing four quarters, delivering an average surprise of 32.82%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have increased to $3.02 from $2.97. Over the same period, EPS estimates for 2027 have risen to $5.31 from $4.81. LQDA shares have gained 163.9% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 54.40%.
Over the past 60 days, estimates for Altimmune’s 2026 loss per share have narrowed from 69 cents to 64 cents. Over the same period, loss estimates for 2027 have also improved from 73 cents to 64 cents. ALT shares have declined 15.6% year to date.
Altimmune’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 15.81%.