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Roche Reports Positive Phase III Data on Eye Drug, FDA Accepts BLA
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Key Takeaways
Roche's vamikibart showed sustained vision gains and reduced macular thickness in two phase III UME studies.
The FDA accepted vamikibart's BLA, with a decision expected by July 2027.
Roche advances pipeline candidates fenebrutinib, sefaxersen and enicepatide to expand growth opportunities.
Roche (RHHBY - Free Report) has reported encouraging one-year data from two phase III studies evaluating investigational vamikibart for uveitic macular edema (UME), a sight-threatening inflammatory eye condition.
The company also announced that the FDA has accepted its biologics license application (BLA) for the drug. Regulatory submissions have also been filed and accepted in the European Union, China and Japan.
Vamikibart is an investigational monoclonal antibody that has been specifically engineered for intravitreal (IVT) administration.
The FDA is expected to make a decision on vamikibart by July 2027. If approved, the drug could become the first non-steroid targeted treatment for UME, offering a new treatment option for patients who face significant risks from existing therapies.
Year to date, shares of Roche have risen 4.9% compared with the industry’s rise of 12.5%.
Image Source: Zacks Investment Research
Data From RHHBY’s Phase III Studies for UME
The latest data from the phase III MEERKAT and SANDCAT studies, presented at the American Academy of Ophthalmology 2026 Annual Meeting, support the potential of vamikibart to deliver rapid and sustained improvements in vision and reductions in macular thickness.
The phase III MEERKAT and SANDCAT studies were identical, global, randomized, double-masked, sham-controlled trials evaluating IVT vamikibart over 52 weeks. Patients received 0.25 mg or 1 mg of vamikibart, or sham injections, every four weeks for up to 16 weeks, followed by as-needed treatment through week 52.
At 52 weeks, a numerically higher proportion of patients treated with vamikibart achieved vision gains compared to those receiving sham treatment in both studies. Key secondary endpoints also demonstrated sustained improvements in best-corrected visual acuity and central subfield thickness, a measure of macular edema.
Vamikibart also demonstrated a relatively low treatment burden. Approximately two-thirds of eligible patients did not require retreatment after the initial 16-week period, while most patients who required additional treatment received only one more injection.
The drug was well tolerated, maintaining a favorable safety profile, with a low incidence of treatment-related ocular adverse events and intraocular inflammation.
UME is the leading cause of moderate-to-severe vision loss among people with uveitis, an inflammatory eye condition. It primarily affects working-age adults, and approximately 20% of patients with UME develop sustained blindness within three years of diagnosis.
UME is commonly treated with off-label therapies or ocular steroids. However, long-term steroid use carries significant risks like glaucoma and cataract formation.
Vamikibart is an investigational monoclonal antibody targeting interleukin-6 (IL-6), a key cytokine involved in the inflammatory pathway underlying UME. Specifically engineered for intravitreal administration, the drug is being developed to address these treatment limitations by targeting the inflammation driving the condition.
Earlier results from the phase I DOVETAIL study showed rapid vision improvements and resolution of macular edema in patients with UME. Vamikibart was also well tolerated, with no treatment-related serious adverse events reported in that study.
Vamikibart has received orphan drug designation in the United States and European Union. Roche is also investigating the drug in retinal diseases with recognized inflammatory pathways, potentially providing additional development opportunities.
RHHBY’s Efforts to Diversify Pipeline
Strong growth from key drugs like Ocrevus, Vabysmo, Hemlibra and Phesgo has helped RHHBY offset declining revenues from legacy drugs.
Vabsymo (faricimab), an ophthalmology drug, is one of the top growth drivers for RHHBY’s top line.
Vabysmo is approved in more than 100 countries, including the United States, Japan, the United Kingdom and the European Union, for treating neovascular or wet age-related macular degeneration (nAMD) and diabetic macular edema (DME). It is also approved in more than 60 countries, including the United States, the European Union and Japan, for macular edema following retinal vein occlusion (RVO). Regulatory reviews by other health authorities are ongoing.
The company recently announced new data from the VOYAGER study evaluating the effectiveness, durability and safety of Vabysmo in nAMD, DME and macular edema following RVO.
Across all study cohorts, the findings reinforced Vabysmo’s real-world effectiveness, consistent with phase III trial results. Previously untreated eyes showed vision gains and substantial anatomical improvements, while previously treated eyes maintained or improved vision alongside further anatomical improvements.
Roche has a diversified pipeline spanning multiple therapeutic areas. The FDA recently accepted its NDA for fenebrutinib, an investigational non-covalent BTK inhibitor for relapsing and primary progressive multiple sclerosis, under priority review. If approved, it could become the first BTK inhibitor and first high-efficacy oral treatment for both conditions.
Roche also reported positive interim phase III results for sefaxersen in primary IgA nephropathy, meeting the primary endpoint with statistically significant and clinically meaningful proteinuria reductions versus placebo at 37 weeks.
Additionally, investigational enicepatide (CT-388), a once-weekly dual GLP-1/GIP receptor agonist, met both primary endpoints in a mid-stage study of adults with type 2 diabetes and overweight or obesity, delivering dose-dependent reductions in HbA1c and body weight at 48 weeks.
Roche is advancing two phase III weight-management studies, ENITH-1 and ENITH-2, and plans to initiate phase III glycemic-control and cardiovascular outcome programs in the first half of 2027.
Shares of Bayer have gained 13.3% year to date. Estimates for BAYRY’s 2026 EPS have increased from $1.28 to $1.29 over the past 60 days.
Over the past 60 days, estimates for CRISPR Therapeutics’ 2026 loss per share have decreased to $4.47 from $4.53. Over the same period, earnings estimates for 2027 have decreased to $3.61 from $3.63.
CRISPR Therapeutics’ earnings beat estimates in two of the trailing four quarters and missed in the other two, with the average negative surprise being 1.38%.
View the Zacks #1 Rank List
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Roche Reports Positive Phase III Data on Eye Drug, FDA Accepts BLA
Key Takeaways
Roche (RHHBY - Free Report) has reported encouraging one-year data from two phase III studies evaluating investigational vamikibart for uveitic macular edema (UME), a sight-threatening inflammatory eye condition.
The company also announced that the FDA has accepted its biologics license application (BLA) for the drug. Regulatory submissions have also been filed and accepted in the European Union, China and Japan.
Vamikibart is an investigational monoclonal antibody that has been specifically engineered for intravitreal (IVT) administration.
The FDA is expected to make a decision on vamikibart by July 2027. If approved, the drug could become the first non-steroid targeted treatment for UME, offering a new treatment option for patients who face significant risks from existing therapies.
Year to date, shares of Roche have risen 4.9% compared with the industry’s rise of 12.5%.
Image Source: Zacks Investment Research
Data From RHHBY’s Phase III Studies for UME
The latest data from the phase III MEERKAT and SANDCAT studies, presented at the American Academy of Ophthalmology 2026 Annual Meeting, support the potential of vamikibart to deliver rapid and sustained improvements in vision and reductions in macular thickness.
The phase III MEERKAT and SANDCAT studies were identical, global, randomized, double-masked, sham-controlled trials evaluating IVT vamikibart over 52 weeks. Patients received 0.25 mg or 1 mg of vamikibart, or sham injections, every four weeks for up to 16 weeks, followed by as-needed treatment through week 52.
At 52 weeks, a numerically higher proportion of patients treated with vamikibart achieved vision gains compared to those receiving sham treatment in both studies. Key secondary endpoints also demonstrated sustained improvements in best-corrected visual acuity and central subfield thickness, a measure of macular edema.
Vamikibart also demonstrated a relatively low treatment burden. Approximately two-thirds of eligible patients did not require retreatment after the initial 16-week period, while most patients who required additional treatment received only one more injection.
The drug was well tolerated, maintaining a favorable safety profile, with a low incidence of treatment-related ocular adverse events and intraocular inflammation.
UME is the leading cause of moderate-to-severe vision loss among people with uveitis, an inflammatory eye condition. It primarily affects working-age adults, and approximately 20% of patients with UME develop sustained blindness within three years of diagnosis.
UME is commonly treated with off-label therapies or ocular steroids. However, long-term steroid use carries significant risks like glaucoma and cataract formation.
Vamikibart is an investigational monoclonal antibody targeting interleukin-6 (IL-6), a key cytokine involved in the inflammatory pathway underlying UME. Specifically engineered for intravitreal administration, the drug is being developed to address these treatment limitations by targeting the inflammation driving the condition.
Earlier results from the phase I DOVETAIL study showed rapid vision improvements and resolution of macular edema in patients with UME. Vamikibart was also well tolerated, with no treatment-related serious adverse events reported in that study.
Vamikibart has received orphan drug designation in the United States and European Union. Roche is also investigating the drug in retinal diseases with recognized inflammatory pathways, potentially providing additional development opportunities.
RHHBY’s Efforts to Diversify Pipeline
Strong growth from key drugs like Ocrevus, Vabysmo, Hemlibra and Phesgo has helped RHHBY offset declining revenues from legacy drugs.
Vabsymo (faricimab), an ophthalmology drug, is one of the top growth drivers for RHHBY’s top line.
Vabysmo is approved in more than 100 countries, including the United States, Japan, the United Kingdom and the European Union, for treating neovascular or wet age-related macular degeneration (nAMD) and diabetic macular edema (DME). It is also approved in more than 60 countries, including the United States, the European Union and Japan, for macular edema following retinal vein occlusion (RVO). Regulatory reviews by other health authorities are ongoing.
The company recently announced new data from the VOYAGER study evaluating the effectiveness, durability and safety of Vabysmo in nAMD, DME and macular edema following RVO.
Across all study cohorts, the findings reinforced Vabysmo’s real-world effectiveness, consistent with phase III trial results. Previously untreated eyes showed vision gains and substantial anatomical improvements, while previously treated eyes maintained or improved vision alongside further anatomical improvements.
Roche has a diversified pipeline spanning multiple therapeutic areas. The FDA recently accepted its NDA for fenebrutinib, an investigational non-covalent BTK inhibitor for relapsing and primary progressive multiple sclerosis, under priority review. If approved, it could become the first BTK inhibitor and first high-efficacy oral treatment for both conditions.
Roche also reported positive interim phase III results for sefaxersen in primary IgA nephropathy, meeting the primary endpoint with statistically significant and clinically meaningful proteinuria reductions versus placebo at 37 weeks.
Additionally, investigational enicepatide (CT-388), a once-weekly dual GLP-1/GIP receptor agonist, met both primary endpoints in a mid-stage study of adults with type 2 diabetes and overweight or obesity, delivering dose-dependent reductions in HbA1c and body weight at 48 weeks.
Roche is advancing two phase III weight-management studies, ENITH-1 and ENITH-2, and plans to initiate phase III glycemic-control and cardiovascular outcome programs in the first half of 2027.
RHHBY’s Zacks Rank and Stocks to Consider
Roche currently has a Zacks Rank #4 (Sell).
A couple of better-ranked stocks in the pharma/biotech sector are Bayer (BAYRY - Free Report) and Crispr Therapeutics (CRSP - Free Report) , both currently carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Shares of Bayer have gained 13.3% year to date. Estimates for BAYRY’s 2026 EPS have increased from $1.28 to $1.29 over the past 60 days.
Over the past 60 days, estimates for CRISPR Therapeutics’ 2026 loss per share have decreased to $4.47 from $4.53. Over the same period, earnings estimates for 2027 have decreased to $3.61 from $3.63.
CRISPR Therapeutics’ earnings beat estimates in two of the trailing four quarters and missed in the other two, with the average negative surprise being 1.38%.