Visus Therapeutics Inc. has expanded its ophthalmic drug portfolio, in-licensing investigational therapies for glaucoma and age-related macular degeneration from Cella Therapeutics LLC, which will be developed by Finland’s Delsitech Ltd. using its extended-release depot technology.
In a deal worth up to $108 million, ophthalmic startup Eluminex Biosciences Ltd. has licensed the global rights to Fibrogen Inc.’s biosynthetic cornea derived from recombinant human collagen (RHC) type III intended to tackle corneal blindness.
LONDON – Oxular Ltd. has raised $37 million in a series B, enabling the company to take OXU-001, its long-acting treatment for diabetic macular edema (DME) into phase II development later this year.
Researchers at the Georgia Institute of Technology see a future where long-lasting hydrogel injections replace eye drops and surgery in the management of glaucoma, the most common cause of irreversible blindness in the world. The treatment would be delivered every six months, in line with glaucoma patients’ regularly scheduled visits to the ophthalmologist.
Ocular Therapeutix Inc. and Affamed Therapeutics Ltd. entered a license and collaboration agreement to develop and commercialize Dextenza and OTX-TIC in greater China, South Korea and the Association of Southeast Asian Nations markets.
LONDON – Gyroscope Therapeutics Ltd. is poised to move the field of ocular gene therapy on from the treatment of inherited rare diseases to address more common eye conditions, after receiving FDA 510(k) clearance for its Orbit SDS subretinal delivery device.
San Clemente, Calif.-based Glaukos Corp. reported 22% net sales growth to $65.8 million in the final quarter of 2019, up from $54.1 million in the same period a year ago. However, it also warned that increasing competition in the microinvasive glaucoma surgery (MIGS) space could dampen 2020 growth in its U.S. glaucoma business. Speaking with analysts on a fourth-quarter earnings call, CEO Thomas Burns said good conversion rates and growing surgeon interest in its next-generation trabecular bypass device, Istent Inject, may not be enough to counter the headwind.
Lineage Cell Therapeutics Inc. CEO Brian Culley told BioWorld that concerns about the pace of the company’s dry age-related macular degeneration (AMD) phase I/IIa trial have been alleviated after an independent data safety monitoring board (DSMB) decreed that the study’s protocol-mandated treatment stagger can be removed.
Shares of Eyegate Pharmaceuticals Inc. (NASDAQ:EYEG) rose 54.8% to $7.09 Friday on news that its ocular bandage gel (OBG) proved superior to standard of care in healing corneal wounds following photorefractive keratectomy (PRK) surgery. The pivotal top-line data will allow the Waltham, Mass.-based company to submit a de novo application to the FDA for commercialization in the first half of 2020, said CEO Stephen From. If approved, the OBG eye drop would be the first product indicated to repair corneal epithelial defects, as well as the first prescription hyaluronic acid (HA) eye drop in the U.S., creating new competition for widely used bandage contact lenses (BCL).
The U.S. FDA has given its final approval to Coopervision Inc.'s Misight 1 day, the first contact lens designed to slow the progression of myopia, or near-sightedness, in children. The single use, disposable, soft contact lens is indicated for children who are diagnosed with myopia and begin Misight treatment at an early age. Specifically, the FDA indication said that "Misight (omafilcon A) daily wear single use soft contact lenses are indicated for the correction of myopic ametropia and for slowing the progression of myopia in children with non-diseased eyes, who at the initiation of treatment are 8-12 years of age and have a refraction of -0.75 to -4.00 diopters (spherical equivalent) with ≤ 0.75 diopters of astigmatism. The lens is to be discarded after each removal."