Samsung Bioepis and Biogen announced that the FDA has approved Byooviz (ranibizumab-nuna), a biosimilar referencing Lucentis (ranibizumab)i, for the treatment of wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV).
Stuart Therapeutics Completes Enrollment in Phase II Trial for Dry Eye Candidate
Stuart Therapeutics, of Stuart, Florida, announced Sept. 8 that it had completed enrollment of 150 patients in a Phase II clinical trial of its eye drop candidate ST-100 in dry eye disease. The multi-center, randomized, double-masked study will evaluate two different dose levels vs. placebo. The company, founded in 2017, has exclusively licensed the worldwide rights to a family of …
Novel digital therapy for amblyopia demonstrates positive phase 3 results
Luminopia One, an investigational digital therapy that allows patients with amblyopia to watch visually modified TV shows and movies to improve vision, has shown positive results, according to a press release from Luminopia. The phase 3 multicenter, randomized, controlled pivotal clinical trial, published in Ophthalmology, was designed to test the safety and efficacy of Luminopia One in patients with amblyopia aged …
Visus Unveils Additional Ophthalmic Drug Candidates for Corneal Wound Healing, Glaucoma and AMD
During its inaugural Capital Markets Day in New York City, Visus Therapeutics unveiled additional ophthalmic drug candidates with applications in development for corneal wound healing, glaucoma and age-related macular degeneration (AMD). Additionally, the company introduced a novel drug delivery platform licensed from DelSiTech that has the potential to help optimize the clinical benefit of ophthalmic therapies.
AbbVie Makes Large Investment in Regenxbio’s Gene Therapy for Retinal Diseases
AbbVie and Regenxbio announced a partnership to develop and commercialize RGX-314, a potential one-time gene therapy for the treatment of wet age-related macular degeneration (AMD), diabetic retinopathy (DR), and other chronic retinal diseases. RGX-314 is currently being evaluated in patients with wet AMD in a pivotal trial utilizing subretinal delivery, and in patients with wet AMD and DR in two separate …
Taiwan Liposome Company to Become Privately Owned Subsidiary of Woods Investment
Taiwan Liposome Company announced Sept. 8 that it would become a private company in late September, about three years after launching a $22 million initial public offering of American Depositary Shares in the US on the Nasdaq Global Market. The company is developing a macular edema treatment candidate and other novel nanomedicines that combine the company’s BioSeizer proprietary lipid-assembled drug …
TearClear Files IND to Begin Study of Glaucoma Drops in Preservative-Filtering Bottle
Boston-based TearClear reported Sept. 8 that it had filed an investigational new drug (IND) application with the US FDA to begin a registrational study of its lead glaucoma candidate, TC-002, a latanoprost ophthalmic solution in a bottle that filters out preservatives.
Apellis Announces Reports Mixed Phase 3 Results for Geographic Atrophy Drug; Will Pursue FDA Approval
Apellis Pharmaceuticals reported topline results from the phase 3 DERBY and OAKS studies evaluating intravitreal pegcetacoplan, an investigational targeted C3 therapy, in 1,258 adults with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Based on results from the studies, the company plans to submit a new drug application (NDA) for pegcetacoplan for GA to the FDA in the first half of 2022.
Oertli Launches Updated Faros Surgical Platform
Oertli has updated its Faros surgical platform with new LED technology. The compact device for anterior and posterior segment surgery provides 45% more light output, and ensures optimal illumination and visualization, according to a company news release. Oertli’s Faros device performs cataract, vitrectomy, and glaucoma surgery. The precise flow control of the peristaltic pump is designed to make the surgeon’s work simple …
MeiraGTx Announces Data at EURETINA 2021 Demonstrating Reversal of Disease Progression Following Treatment With AAV5-RPGR in XLRP
MeiraGTx Holdings announced new data from subjects treated in the phase 1/2 dose escalation phase of Study MGT009 indicating AAV5-RPGR, an investigational gene therapy in development for the treatment of X-linked retinitis pigmentosa (XLRP), reverses course of disease progression when retinal function assessed 12 months following treatment with AAV5-RPGR is compared with retinal function in these same subjects up to …