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Home » Topics » Ocular, BioWorld

Ocular, BioWorld
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Innovent’s IBI-302 meets phase II endpoints in neovascular AMD

May 6, 2025
By Tamra Sami
No Comments
Innovent Biologics Inc.’s efdamrofusp alfa (IBI-302) met the primary endpoint in phase II, showing a gain of 10 or more letters in visual acuity from baseline at one year in Chinese patients with neovascular age-related macular degeneration.
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Woman using eyedrops

Aldeyra DED phase III hits but reproxalap field goal fumbled

May 6, 2025
By Randy Osborne
No Comments
Aldeyra Therapeutics Inc. is making another run at U.S. FDA clearance for reproxalap in dry eye disease (DED) after nailing the primary endpoint in a phase III randomized, double-masked, vehicle-controlled dry eye chamber trial of 0.25% ophthalmic solution.
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Eye with bar chart, line graph

Street’s syringe whinges, sales dip dog Regeneron’s Eylea in AMD

April 29, 2025
By Randy Osborne
No Comments
Another complete response letter from the U.S. FDA for Regeneron Pharmaceuticals Inc.’s age-related macular degeneration (AMD) therapy Eylea (aflibercept) – along with disappointing sales of the VEGF inhibitor – dented shares (NASDAQ:REGN) by $41.95. They closed April 29 at $568.91, having traded as low as $542.44 during the day.
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Colorful illustration of reconstructed brain cells
Neurology/psychiatric

Mouse brain structure and function shown on high-resolution map

April 11, 2025
By Mar de Miguel
Scientists from the Machine Intelligence from Cortical Networks (MICRONS) consortium have published the microconnectome of a cubic millimeter of the mouse brain. This is the most complete map of this organ to date at nanometer resolution for a mammal. It not only contains the structure and connections of each and every cell in that volume of tissue, but is also linked to the neuronal activity of that portion of the CNS, linking anatomy and function in the same cells.
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Face with digital focus on eye

Reproxalap rapped again in DED; second Aldeyra CRL

April 3, 2025
By Randy Osborne
Aldeyra Therapeutics Inc. is hoping that research already underway will satisfy the U.S. FDA, which delivered to the company another complete response letter (CRL) related to the NDA for reproxalap in dry eye disease (DED).
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Opthea shutters phase III trials in wet AMD

March 31, 2025
By Tamra Sami
After announcing that lead candidate sozinibercept (OPT-302) failed the phase III Coast trial in wet age-related macular degeneration (AMD), Opthea has now decided to close the Coast trial as well as the Shore trial. As reported by BioWorld, Opthea announced last week that it was considering its options after lead candidate sozinibercept (OPT-302) failed the phase III Coast trial in wet AMD.
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Alzheimer’s drug Kisunla rejected by European regulators

March 28, 2025
By Nuala Moran
The EMA has rejected the Alzheimer’s disease therapy Kisunla (donanemab) from Eli Lilly and Co., saying the benefits of the anti-amyloid antibody do not outweigh the risks of edema and hemorrhage in the brain, known as amyloid-related imaging abnormalities (ARIA).
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Unity eyes path forward for UBX-1325 despite missed DME endpoint

March 24, 2025
By Jennifer Boggs
Shares of Unity Biotechnology Inc. (NASDAQ:UBX) sank 28.8% to close at $1.30 March 24 as a top-line readout of its phase IIb Aspire study testing UBX-1325 head-to-head against aflibercept in diabetic macular edema (DME) fell short of statistical noninferiority on the primary analysis endpoint. But that’s not the full story, according to company executives, who have plans for moving the senolytic Bcl-xL inhibitor into late-stage studies.
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Opthea in freefall after phase III fail in wet AMD

March 24, 2025
By Tamra Sami
Opthea Ltd. is considering its options after lead candidate sozinibercept (OPT-302) failed the phase III Coast trial in wet age-related macular degeneration (AMD). The global Coast phase III trial evaluated the efficacy and safety of intravitreally administered 2-mg sozinibercept every four or eight weeks in combination with 2-mg aflibercept every eight weeks after a loading phase for the treatment of wet AMD. The trial did not meet its primary endpoint of mean change in best corrected visual acuity from baseline to week 52.
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China accepts NDA of influenza tablet, clears Tepezza biosimilar

March 18, 2025
By Marian (YoonJee) Chu
China’s National Medical Products Administration (NMPA) approved the country’s first injectable teprotumumab biosimilar from Innovent Biologics Inc. under the brand name of Sycume (teprotumumab N-01) to treat thyroid eye disease on March 14. The NMPA on March 15 accepted Simcere Pharmaceutical Group Ltd.’s NDA of deunoxavir marboxil (ADC-189) tablets, a product originally developed by Jiaxing Andicon Biotech Co. Ltd. to treat influenza A and B.
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