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Ocular’s OTX-DED Succeeds In Dry Eye Where OTX-CSI Failed, But More Data Needed

 
• By Alaric DeArment

The Phase II trial showed significant improvement in eye redness in patients with dry eye disease, but additional data are needed on DED symptom improvement.

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Ocular's OTX-DED has data sufficient to continue development in dry eye disease • Source: Shutterstock

Ocular Therapeutix, Inc. can move ahead with clinical development of its new dexamethasone ocular insert OTX-DED after showing statistically significant improvement in bulbar conjunctival hyperemia. However, the company will need to produce more data on how well the product works at actually improving dry eye symptoms, particularly as little separation appeared between the OTX-DED and vehicle hydrogel insert arms, especially entering a market that is getting crowded.

The company announced results of the randomized, double-masked Phase II study on 6 December. Among 166 patients enrolled in the...

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

 
• By Manas Mishra

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

 
• By Sushmita Panda

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

 
• By Sushmita Panda

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

 
• By Kevin Grogan

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

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BMS/Pfizer To Sell Discounted Eliquis Direct – And Other Drugmakers May Follow Suit

 
• By Alaric DeArment

Analysts see the new strategy as a way to address pressure from the Trump administration’s most favored nation drug pricing proposals.

Actuate Is Looking For A Buyer To Advance Pancreatic Cancer Candidate

 
• By Jessica Merrill

After presenting encouraging Phase II data on the GSK-3 inhibitor elraglusib at ASCO, Actuate Therapeutics is hoping to hold a pre-NDA meeting with the US FDA.

Novartis Upbeat Even With Entresto Expiry Looming

 
• By Kevin Grogan

Swiss major confident that new oncology drugs will fill revenue gap.