Ophthalmology

In Brief: Nanoscope Ploughs Forward With FDA Application For Retinitis Pigmentosa Gene Therapy

 
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Nanoscope’s experimental gene therapy, MCO-010, is designed to target the broader retinitis pigmentosa population, regardless of the underlying gene mutation, with a completed US regulatory submission expected in early 2026.

In Brief: 4DMT Fast-Tracks Long-Acting Wet AMD Therapy Trials, Cuts 25% Of Workforce

 

4D Molecular Therapeutics has fast-tracked its Phase III trials for 4D-150 in wet AMD, with top-line data from one now expected in H1 2027 and another underway ahead of schedule. The company is also cutting a quarter of its staff as it focuses on its late-stage pipeline and to help fund the trials.

In Brief: Opus Gears Up For FDA Filing In Presbyopia

 

Data from a second pivotal trial support a filing in the US for Opus Genetics’ phentolamine ophthalmic solution, to treat presbyopia.

Bayer Buoyant After EU Nod For Twice-Yearly Eylea

 
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Green light follows a recent rejection by the US FDA to partner Regeneron's request for an extension to the dosing interval.


Spain’s SpliceBio Secures Sanofi and Roche Support In $135m Financing

 
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Series B cash will be used to advance its Stargardt disease gene therapy.

Santen Sees Potential In Myopia Market After Ryjunea Approval

 
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The low-dose atropine eye drop slowed the progression of pediatric myopia by 30%.

In Brief: Nicox Extends Cash Runway As Kowa Advances NCX 470 In Japan

 

Eye drug is already in Phase III trials elsewhere, with results due in Q3. Nicox could earn up to a further €24.5m in milestones and royalties from Kowa alliance.

Mission Vision: How Roche Hopes To Impact Eye Health Outcomes In APAC

 

Roche Pharmaceuticals’ area head, Asia Pacific, outlines how the Swiss group is helping nurture the wider ecosystem and setting itself up for a bigger play in the ophthalmology space by combining scientific expertise with regional insights.


Merck & Co. CMO Barr On Breaking Into Immunology And Ophthalmology

 

Chief medical officer Eliav Barr discussed Merck’s investment in new therapeutic areas and business development in an interview with Scrip.

Outlook Holds Out Hope For Wet AMD Approval Despite Phase III Topline Miss

 

The company said the NORSE EIGHT trial of ONS-5010 did not meet the primary endpoint of showing noninferiority to ranibizumab, but it still plans to file for US FDA approval.

Clearside Clears Way For Phase III After Positive CLS-AX Results In Wet AMD

 

The company is developing the drug as a way to reduce injection burden for wet AMD patients and plans to meet with the US FDA early next year to discuss Phase IIb topline results.

Santen Fortifies Glaucoma Strategy With Sepetaprost Japan Filing

 
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The dual agonist of the FP and EP3 receptors has shown efficacy in a Japanese Phase III trial and completed its US Phase II study, which aligns with the Japanese firm’s global expansion strategy for glaucoma products.


Viridian’s Veligrotug Poses Formidable Challenge For Amgen’s Tepezza In TED

 

Results from the Phase III THRIVE trial in active thyroid eye disease had analysts calling veligrotug “best-in-class” as they anticipate results from THRIVE-2 in chronic TED later this year.

Small But Mitey: Tarsus To Amp Up Strong Xdemvy Launch

 

Tarsus Pharmaceuticals is putting more sales and marketing heft behind its novel eyelid disease therapy, Xdemvy, to capitalize on a solid start in a previously untapped market.    

Aldeyra Readies Reproxalap For Dry Eye Refiling After Chamber Study Success

 
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The company said earlier this year that it would resubmit reproxalap for US FDA approval before the end of 2024 once it completed another Phase III trial and is eyeing both acute and chronic use.

Roche’s Vabysmo Sees The Only Growth In RVO

 

Sales of the Swiss group’s bispecific in retinal vein occlusion are forecast to increase out to 2030 as sales of Eylea and Lucentis fall.    


Roche On Track To Supplement Relaunched Susvimo’s Label

 
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Having relaunched Susvimo for wet AMD, Roche now has the ocular implant under FDA review for approval in two diabetic ophthalmic indications and presented two-year data in those settings.

Adverum, 4D Molecular Present Dueling Phase II Datasets In Wet AMD

 
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The two biotechs each hope to offer an Eylea-sparing regimen to wet age-related macular degeneration patients with gene therapies that induce natural production of aflibercept.

Roche’s Susvimo Returns, But Destined To Be Vabysmo’s Support Act

 

The implantable eye treatment will be back on the market soon, but risk of eye infections and complications remain higher than with injectable treatments, meaning it will play second fiddle to Vabysmo.