Gemini Announces Phase I Study Results
Gemini Therapeutics announced the small-scale Phase I study of GEM103, the company’s investigational treatment for dry age-related macular degeneration, met all endpoints. Results demonstrated that, in 12 patients receiving a single intravitreal injection of GEM103, no dose-limiting toxicities or treatment-related adverse events were reported. The results were presented during a virtual poster session at the 2020 American Academy of Ophthalmology virtual meeting.
Investigational RPGR Therapy in X-linked RP Patients
The Janssen Pharmaceutical Companies of Johnson & Johnson announced 12-month data from the ongoing Phase I/II trial of an investigational gene therapy for inherited retinal disease X-linked retinitis pigmentosa. They say that the results show that low and intermediate doses were well-tolerated and continued to demonstrate statistically significant sustained or increased vision improvement. Data on the novel adeno-associated virus retinitis pigmentosa GTPase regulator, jointly developed with MeiraGTx Holdings, were presented at the American Academy of Ophthalmology virtual meeting. Read more.
Topcon Announces U.S. Launch of Chronos
Topcon Healthcare launched the Chronos Automated Binocular Refraction System with SightPilot guided refraction software. The digital refraction solution combines autorefraction, keratometry and subjective refraction in a single device that occupies less than four feet of space. SightPilot, a fully automated system, features guided refraction software designed to be easily operated by anyone in the practice, the company says. Binocular testing means refractions can take as little as three-and-a-half minutes, Topcon says. Read more.
Lineage Presents New OpRegen Data for Dry AMD with GA
Lineage Cell Therapeutics announced positive interim results from the ongoing 24-patient Phase I/IIa clinical study of the company’s therapy, OpRegen. OpRegen is an investigational cell therapy consisting of allogeneic retinal pigment epithelium cells administered to the subretinal space for the treatment of dry age-related macular degeneration with geographic atrophy. At the American Academy of Ophthalmology virtual meeting, the company says that data showed improvements in visual acuity in cohort-four patients, with treated vs. fellow eye comparisons reaching statistical significance at nine and 12 months. Read more.
Kodiak Completes Enrollment of DAZZLE Phase IIb/III KSI-301 Study
Kodiak Sciences announced that recruitment concluded in its DAZZLE pivotal study of KSI-301, an anti-VEGF antibody biopolymer conjugate, in patients with neovascular age-related macular degeneration. Read more.
Novartis Reports Data & Post-hoc Analysis of Beovu Trials
Novartis reported initial findings from a coalition convened to answer key questions related to treatment with Beovu (brolucizumab) for adults with wet age-related macular degeneration. Analyses of U.S. real-world and Phase III data presented at the American Academy of Ophthalmology virtual meeting identified baseline patient characteristics potentially associated with the incidence of inflammation-related adverse events that may occur following treatment with Beovu. Novartis says it has a comprehensive program under way to examine the root cause and potential risk factors for these events, and to identify mitigation strategies and treatment protocols. Read more.
Innovent Announces Phase I IBI302 Trial Results
Innovent Biologics announced at the American Academy of Ophthalmology virtual meeting that IBI302, the company’s recombinant human anti-VEGF and anti-complement bi-specific fusion protein for neovascular AMD, demonstrated good safety and tolerability in a Phase I clinical trial. Read more.
Adverum Announces Interim Data from OPTIC Phase I Trial
Adverum Biotechnologies announced positive new interim data from cohorts one to four in the OPTIC Phase I clinical trial of ADVM-022 intravitreal injection gene therapy in individuals requiring frequent anti-VEGF injections for wet AMD. Adverum says the therapy continues to maintain efficacy at high and low doses. Read more.