On the strength of upside in best corrected visual acuity (BCVA) in patients with geographic atrophy (GA), Annexon Inc. officials will meet with the U.S. FDA to talk about what’s next for ANX-007, after the C1q inhibitor missed the phase II trial’s primary endpoint: mean rate of change, or slope, in the GA lesion area compared to sham.
Hanall Biopharma Co. Ltd.’s phase III trial VELOS-3 of tanfanercept did not show effects on the central cornea of the eye or in eye dryness in the treatment of moderate to severe dry eye disease, the primary endpoints. Data from the trial did show improvements in tear production, a secondary endpoint.
With its sights firmly set on being the first company to bring a topical diabetic macular edema (DME) treatment to market, Oculis Holding AG moved a step closer to this potentially game-changing reality as its dexamethasone formulation, OCS-01, turned up a statistically significant improvement in mean BCVA – a measure of visual acuity – at the three-month mark in the phase III DIAMOND trial.
Less than a year after submitting their NDA and several weeks before the June 28 PFUFA date, Bausch + Lomb Corp. and partner Novaliq GmbH have been awarded U.S. FDA approval for Miebo, their perfluorohexyloctane eye drop formulation designed to treat the signs and symptoms of dry eye disease associated with meibomian gland dysfunction.
Ray Therapeutics Inc.’s upsized and oversubscribed $100 million series A financing will support the firm’s ongoing efforts with optogenetics, an approach that deploys adeno-associated virus (AAV) gene therapy to deliver a light-sensitive, highly bioengineered protein found in nature to retinal cells.
Astellas Pharma Inc. announced it plans to acquire Iveric Bio Inc. in an all-cash deal in which it will pay $40 per Iveric share for a total equity value of roughly $5.9 billion. “Iveric Bio has promising programs including avacincaptad pegol (Zimura), an important program for geographic atrophy secondary to age-related macular degeneration, and capabilities across the entire value chain in the ophthalmology field,” said Naoki Okamura, Astellas’ president and CEO.
Touting what’s been so far the “cleanest safety profile that’s been presented with genetic medicine in the eye,” deemed “a game changer for this field,” 4D Molecular Therapeutics Inc. CEO David Kirn said phase III planning will begin in later this year to test gene therapy 4D-150 in wet age-related macular degeneration (AMD).
Complement Therapeutics GmbH raised €72 million (US$79.4 million) in a series A round to move into the clinic a novel gene therapy for treating geographic atrophy secondary to dry age-related macular degeneration. It’s the largest series A round completed in Europe so far this year.
PYC Therapeutics Ltd.’s lead candidate, VP-001, is entering the clinic, and the RNA therapy could be the first potential treatment for retinitis pigmentosa type 11, which causes blindness that begins in childhood and ultimately leads to legal blindness by middle age.
Japan’s PMDA has approved Aurion Biotech Inc.’s cell therapy, Vyznova, for the treatment of bullous keratopathy of the cornea, making it the first-ever approval of a cell therapy to treat corneal endothelial disease.
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