Eyevensys has entered into strategic engagements with US-based medical device manufacturers Phillips-Medisize and Minnetronix Medical to develop the next generation of the company’s core technology. Terms of the deal were not diclosed. Eyevensys has developed a non-viral gene therapy ocular drug delivery platform with a proprietary Electrotransfection System designed to deliver DNA plasmids encoding therapeutic proteins into the ciliary muscle and sustainably treat major eye diseases. …
Novartis Acquires Arctos Medical, Expanding Optogenetic Gene Therapy Pipeline
Swiss company Novartis announced Sept. 21 that it had acquired Arctos Medical, developer of a potential optogenetic AAV gene therapy for inherited retinal disease. Financial details were not disclosed. The move comes a year after Novartis paid $150 million up front and a potential $130 million in milestone payments in September 2020 for Vedere Bio of Cambridge, Massachusetts.
Diagnostic Device Makers Luneau, Optovue Announce Merger
Ophthalmic diagnostic device manufacturers Luneau Technology, of France, and Optovue, of Fremont, California, have announced an agreement to merge. Terms of the deal were not disclosed. The companies said their combined power will allow them to leverage their industry expertise, strengthen their international footprint, and provide customers with a full product range.
FDA Approves Samsung Bioepis and Biogen’s Byooviz Lucentis Biosimilar (ranibizumab-nuna)
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.