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EyePoint (EYPT) Surges 178% on Upbeat Phase II Eye Disease Data
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EyePoint Pharmaceuticals, Inc. (EYPT - Free Report) , a clinical-stage company, announced positive top-line results from a mid-stage study of its investigational candidate, EYP-1901, in the treatment of wet age-related macular degeneration (wet AMD).
EYP-1901 is EyePoint’s novel sustained delivery maintenance treatment, which is being developed by combining vorolanib, a selective tyrosine kinase inhibitor, with the company’s proprietary bioerodible Durasert E technology.
The phase II DAVIO 2 study enrolled 160 wet AMD patients who were previously treated with a standard-of-care anti-VEGF therapy. The total patient population was then randomly divided to receive either a dose of EYP-1901 (2 mg or 3 mg) or Regeneron’s Eylea (control arm).
Per the data readout, the phase II DAVIO 2 study met its primary endpoint with both EYP-1901 doses (2mg and 3 mg), observing a statistical non-inferiority change in best corrected visual acuity compared with Regeneron’s (REGN - Free Report) Eylea (aflibercept).
Furthermore, treatment with EYP-1901 demonstrated a favorable safety profile with no drug-related ocular or systemic serious adverse events.
EyePoint’s stock skyrocketed 177.5% in the last trading session as the investors cheered the successful mid-stage wet AMD study. The stock also gained about 3% in the after hours on Monday. Year to date, shares of EYPT have rallied 457.1% against the industry’s 21.2% fall.
Image Source: Zacks Investment Research
The mid-stage study also achieved key secondary endpoints with both EYP-1901 doses, which included a reduction in treatment burden of more than 80%, nearly two-thirds of eyes supplement-free up to six months and over 80% receiving only zero or one supplement up to six months. EyePoint further reported that both doses of EYP-1901 demonstrated strong anatomical control as measured by optical coherence tomography.
Per the company, the phase II DAVIO 2 study was designed to support the initiation of phase III clinical studies following feedback received from the FDA at a Type C meeting last year. The positive top-line phase II data strongly supports EyePoint’s planned phase III non-inferiority design, consistent with the FDA’s recent guidance for wet AMD clinical studies.
Based on the successful phase II study, EYPT expects to continue dialogues with the FDA regarding its phase III plans as it gears up to initiate its first pivotal study for wet AMD in the second half of 2024.
Eyepoint is also currently evaluating EYP-1901 in other retinal vascular indications like diabetic macular edema (DME) and non-proliferative diabetic retinopathy (NPDR). The company reported that it is remaining on track to initiate the phase II VERONA study on EYP-1901 in DME in the first quarter of 2024. EYPT also expects to share top-line data from its phase II PAVIA study of the candidate in NPDR in the second quarter of 2024.
EYEPOINT PHARMACEUTICALS, INC. Price and Consensus
Regeneron’s Eylea is a leader in the treatment of wet AMD, DME and macular edema following retinal vein occlusion (RVO), which includes macular edema following central RVO and macular edema following branch RVO. REGN co-develops Eylea with Bayer’s (BAYRY - Free Report) HealthCare unit.
Per the terms of the agreement, Bayer holds the license to exclusive marketing rights of Eylea outside the United States and the profits from its sales are shared equally between the companies. Regeneron retains exclusive commercial rights to Eylea Injection in the United States.
Another company, Kodiak Sciences (KOD - Free Report) , is currently evaluating treatments for eye disease. KOD recently announced rebooting its tarcocimab tedromer, a novel anti-VEGF antibody biopolymer conjugate, development program. The company previously paused further development of tarcocimab last summer after the failure of its phase III GLEAM and GLIMMER studies in DME.
However, positive data readouts from Kodiak’s DAYLIGHT, BEACON and GLOW studies gave the company three successful phase III pivotal studies with tarcocimab tedromer across three different retinal vascular and exudative diseases, such as wet AMD, RVO and NPDR.
KOD believes that it has a clear regulatory pathway requiring one additional positive pivotal study to support a single biologics license application submission for all three indications (wet AMD, RVO and NPDR).
Image: Bigstock
EyePoint (EYPT) Surges 178% on Upbeat Phase II Eye Disease Data
EyePoint Pharmaceuticals, Inc. (EYPT - Free Report) , a clinical-stage company, announced positive top-line results from a mid-stage study of its investigational candidate, EYP-1901, in the treatment of wet age-related macular degeneration (wet AMD).
EYP-1901 is EyePoint’s novel sustained delivery maintenance treatment, which is being developed by combining vorolanib, a selective tyrosine kinase inhibitor, with the company’s proprietary bioerodible Durasert E technology.
The phase II DAVIO 2 study enrolled 160 wet AMD patients who were previously treated with a standard-of-care anti-VEGF therapy. The total patient population was then randomly divided to receive either a dose of EYP-1901 (2 mg or 3 mg) or Regeneron’s Eylea (control arm).
Per the data readout, the phase II DAVIO 2 study met its primary endpoint with both EYP-1901 doses (2mg and 3 mg), observing a statistical non-inferiority change in best corrected visual acuity compared with Regeneron’s (REGN - Free Report) Eylea (aflibercept).
Furthermore, treatment with EYP-1901 demonstrated a favorable safety profile with no drug-related ocular or systemic serious adverse events.
EyePoint’s stock skyrocketed 177.5% in the last trading session as the investors cheered the successful mid-stage wet AMD study. The stock also gained about 3% in the after hours on Monday. Year to date, shares of EYPT have rallied 457.1% against the industry’s 21.2% fall.
Image Source: Zacks Investment Research
The mid-stage study also achieved key secondary endpoints with both EYP-1901 doses, which included a reduction in treatment burden of more than 80%, nearly two-thirds of eyes supplement-free up to six months and over 80% receiving only zero or one supplement up to six months. EyePoint further reported that both doses of EYP-1901 demonstrated strong anatomical control as measured by optical coherence tomography.
Per the company, the phase II DAVIO 2 study was designed to support the initiation of phase III clinical studies following feedback received from the FDA at a Type C meeting last year. The positive top-line phase II data strongly supports EyePoint’s planned phase III non-inferiority design, consistent with the FDA’s recent guidance for wet AMD clinical studies.
Based on the successful phase II study, EYPT expects to continue dialogues with the FDA regarding its phase III plans as it gears up to initiate its first pivotal study for wet AMD in the second half of 2024.
Eyepoint is also currently evaluating EYP-1901 in other retinal vascular indications like diabetic macular edema (DME) and non-proliferative diabetic retinopathy (NPDR). The company reported that it is remaining on track to initiate the phase II VERONA study on EYP-1901 in DME in the first quarter of 2024. EYPT also expects to share top-line data from its phase II PAVIA study of the candidate in NPDR in the second quarter of 2024.
EYEPOINT PHARMACEUTICALS, INC. Price and Consensus
EYEPOINT PHARMACEUTICALS, INC. price-consensus-chart | EYEPOINT PHARMACEUTICALS, INC. Quote
Regeneron’s Eylea is a leader in the treatment of wet AMD, DME and macular edema following retinal vein occlusion (RVO), which includes macular edema following central RVO and macular edema following branch RVO. REGN co-develops Eylea with Bayer’s (BAYRY - Free Report) HealthCare unit.
Per the terms of the agreement, Bayer holds the license to exclusive marketing rights of Eylea outside the United States and the profits from its sales are shared equally between the companies. Regeneron retains exclusive commercial rights to Eylea Injection in the United States.
Another company, Kodiak Sciences (KOD - Free Report) , is currently evaluating treatments for eye disease. KOD recently announced rebooting its tarcocimab tedromer, a novel anti-VEGF antibody biopolymer conjugate, development program. The company previously paused further development of tarcocimab last summer after the failure of its phase III GLEAM and GLIMMER studies in DME.
However, positive data readouts from Kodiak’s DAYLIGHT, BEACON and GLOW studies gave the company three successful phase III pivotal studies with tarcocimab tedromer across three different retinal vascular and exudative diseases, such as wet AMD, RVO and NPDR.
KOD believes that it has a clear regulatory pathway requiring one additional positive pivotal study to support a single biologics license application submission for all three indications (wet AMD, RVO and NPDR).
Zacks Rank
EyePoint currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.