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BioWorld - Wednesday, April 8, 2026
Home » Topics » Ocular, BioWorld

Ocular, BioWorld
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Eye drops

Tenpoint advantage? FDA clears presbyopia duo-drop

Jan. 29, 2026
By Randy Osborne
No Comments
The presbyopia space gained another player as Tenpoint Therapeutics Ltd. won the U.S. FDA’s go-ahead for Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution, 2.75%/0.1%, previously known as Brimochol PF), the first and only dual-agent eye drop for the treatment of adult presbyopia.
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Close up of man's eye

Going Ollin on AMD, DME: Vabysmo in phase Ib crosshairs

Jan. 9, 2026
By Randy Osborne
No Comments
Ollin Biosciences Inc. is gearing up for global phase III trials this year after disclosing favorable top-line results from its randomized, head-to-head phase Ib Jade study comparing OLN-324, a next-generation VEGF/Ang2 bispecific antibody, to Vabysmo (faricimab, Roche AG), which takes aim at the same targets. The drugs were tested in more than 160 patients with diabetic macular edema (DME) or wet age-related macular degeneration (AMD).
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Close-up of eye with digital focus

Missed window? A third CRL sinks Outlook’s ONS-5010

Jan. 2, 2026
By Karen Carey
No Comments
Receiving a third complete response letter (CRL) from the U.S. FDA for its bevacizumab formulation, ONS-5010, to treat wet age-related macular degeneration, Outlook Therapeutics Inc. watched its stock (NASDAQ:OTLK) plummet nearly 62% to a 52-week low of 60 cents on Jan. 2.
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Businesspeople shaking hands, meeting with cityscape, charts

Deals and an M&A strengthen end-of-year numbers

Dec. 16, 2025
By Lee Landenberger
No Comments
Two large deals and an acquisition, totaling about $4.64 billion in all, are helping wrap up what’s turning out to be a strong year. Through the first 11 months of 2025, biopharma dealmaking was robust with a collective value of $261.14 billion, the highest January through November total of the past seven years and well above 2024’s $201.35 billion. These three December deals helped revive the surge in dealmaking that had cooled in November.
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Eye with blue graphic overlays

Belite cements Stargardt position with phase III tinlarebant win

Dec. 1, 2025
By Randy Osborne
No Comments
Attention has turned to the regulatory path worldwide after Belite Bio Inc. unveiled positive top-line data from the phase III Dragon study with oral, daily tinlarebant in Stargardt disease type 1, the most common form of the rare affliction.
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Eye chart and teen with laser over eye

Magnum Opus: Street drinks in LCA5 gene therapy phase I/II data

Sep. 30, 2025
By Randy Osborne
No Comments
Opus Genetics Inc. will be sitting down with the U.S. FDA to talk about positive three-month data from the pediatric cohort of its ongoing phase I/II trial called OPGx-LCA5-1001 – partially funded by the agency – evaluating OPGx-LCA5, a gene augmentation therapy for ultra-rare Leber congenital amaurosis type 5 (LCA5). The affliction is a severe form of retinal dystrophy that renders babies blind in the first year of life.
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Close up of eye and vision test

Cornea field growing nicely; harvest ahead for Kala?

Sep. 18, 2025
By Randy Osborne
No Comments
As Wall Street awaits phase IIb data from Kala Bio Inc. with KPI-012 in persistent corneal epithelial defect, odds are being weighed for that candidate – and others in development – against the lone approved treatment used in a market already worth more than $1 billion.
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Close-up of eye with digital focus
Newco news

Ollin eyes next-gen ophthalmology space, launches with $100M

Sep. 17, 2025
By Jennifer Boggs
No Comments
To say the team at Ollin Biosciences Inc. has some experience in ophthalmology would be an understatement. The company, which emerged from stealth with $100 million in venture capital and two in-licensed assets with plans to add more, brings to the table years of expertise from work on blockbuster retinal disease drugs Lucentis (ranibizumab, Roche AG) and Vabysmo (faricimab, Roche AG).
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Stem cells

ARDD 2025: Hitting rewind, not reset, for in vivo rejuvenation

Aug. 29, 2025
By Anette Breindl
No Comments
At the 12th Aging Research & Drug Discovery (ARDD) Meeting, which is being held this week in Copenhagen, Life Biosciences Inc. announced that it is developing its partial epigenetic reprogramming technology for liver disease as well as optic neuropathies. The company’s chief scientific officer Sharon Rosenzweig-Lipson estimated that its ER-100 would enter clinical trials in early 2026, putting it on track to be the first application of partial epigenetic reprogramming to enter the clinic.
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Trial verdict unclear in Outlook CRL for AMD therapy

Aug. 28, 2025
By Randy Osborne
No Comments
After Outlook Therapeutics Inc. took receipt of another complete response letter (CRL), Wall Street focused on the odds that the U.S. FDA will demand a new study with ONS-5010, or Lytenava (bevacizumab-vikg) against wet age-related macular degeneration (AMD).
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