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.
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.
4D Molecular Therapeutics Inc.’s gene therapy, 4D-150, in wet age-related macular degeneration (wet AMD) produced positive phase IIb data as the company preps two phase III studies set to begin this year.
Allovir Inc., which has struggled since late last December, will merge with privately held Kalaris Therapeutics Inc. to develop therapies for treating neovascular and exudative retinal diseases. Kalaris already has an anti-VEGF treatment in a phase I study with a data readout set for the third quarter of 2025. Once the deal closes, the combined company name will be Kalaris Therapeutics Inc. and shares will trade on Nasdaq as KLRS. The new company said it plans to drive development of TH-103 for treating neovascular age-related macular degeneration (nAMD), diabetic macular edema and retinal vein occlusion. The phase I study is for treatment of nAMD.
Innovec Pharmaceutical Technology Co. Ltd. (Innovec Biotherapeutics) has received FDA clearance for its IND application for IVB-103, an AAV-based gene therapy for neovascular age-related macular degeneration (AMD).
As the hunt goes on for a better treatment in wet age-related macular degeneration (AMD), landmark analyses of two batches of phase II gene therapy data billed as positive were disclosed during the American Society of Retina Specialists annual meeting in Stockholm, where 4D Molecular Therapeutics Inc. and Adverum Biotechnologies Inc. offered findings.
Nexthera Co. Ltd. has submitted an IND application to the FDA seeking to conduct a phase I/IIa trial with NT-101, a noninvasive eye drop treatment for wet age-related macular degeneration (AMD).
Altos Biologics Inc., founded as an eye disease-focused subsidiary of Alteogen Inc. in 2020, raised ₩24.5 billion (US$17.7 million) in a series B financing round to advance its pipeline of therapeutics for eye-related conditions, including age-related macular degeneration (AMD). Daejeon, South Korea-based Alteogen said July 9 that the funds raised will be funneled to develop OP-01, Altos’ candidate therapy for AMD.
France’s Théa Open Innovation, a subsidiary of Laboratoires Théa SAS, terminated its licensing agreement with South Korea’s Olix Pharmaceuticals Inc., and returned global rights of Olix’s ocular small interfering RNA (siRNA) biologic agents, OLX-301D and OLX-301A.
France’s Théa Open Innovation, a subsidiary of Laboratoires Théa SAS, terminated its licensing agreement with South Korea’s Olix Pharmaceuticals Inc., and returned global rights of Olix’s ocular small interfering RNA (siRNA) biologic agents, OLX-301D and OLX-301A.
