Therapeutics

Atsena Therapeutics and Nippon Shinyaku have formed an exclusive licensing agreement for ATSN-101, a gene therapy for Leber congenital amaurosis (LCA1). Nippon Shinyaku will commercialize ATSN-101 in the U.S. and Japan, while Atsena retains global rights outside these territories.

Study highlights safety, efficacy of device in managing persistent DED.

Harrow announced that starting in January 2025, Vevye will be covered under key Medicare Part D formularies and across major insurance programs, expanding access to the dry eye disease treatment for millions of patients, particularly older adults.

A Johns Hopkins study reveals that anti-VEGF treatments for wet AMD may unintentionally elevate ANGPTL4, a protein that promotes blood vessel growth. Combining anti-VEGF with an experimental drug targeting HIF-1 could enhance vision outcomes and prevent vision loss.

The phase 3 trial was conducted by licensee, Grand Pharma in Chinese cataract surgery patients.

According to the company, Duravyu 2.7 mg demonstrated an early and sustained anatomical improvement mirroring BCVA results with a 68 micron reduction in CST. Full topline data is anticipated in Q1 of 2025.

According to the company, the second Phase 3 LUCIA pivotal trial first patient dosing is expected by end of 2024 with topline data anticipated in 2026.

According to OKYO Pharma, OK-101 is the first drug candidate to enroll patients specifically diagnosed with neuropathic corneal pain in a clinical trial. The Phase 2 trial is designed as a randomized, placebo-controlled, double-masked study to treat 48 NCP patients.

According to the company, its data replicate and expand upon the potential of ER-100 to improve retinal ganglion cell function and restore visual function in a nonhuman primate model of nonarteritic anterior ischemic optic neuropathy.

New research presented at the American Academy of Ophthalmology’s Cornea Subspecialty Day is part of the part of the 8-year Zoster Eye Disease Study.

According to the company, the axitinib injectable suspension achieved all primary and secondary outcomes and maintained stable visual acuity and anatomical control over 9 months.

According to the company, a $68 million Series D financing is co-led by Arboretum Ventures and Johnson & Johnson Innovation – JJDC Inc. It also has secured $15 million in structured capital from Catalio Capital Management, with $10 million drawn at closing.

Marketed as Triesence, it is a preservative free synthetic corticosteroid that is approved by the FDA for visualization during vitrectomy and for the treatment of ocular inflammatory conditions that are unresponsive to topical corticosteroids.

Clobetasol is FDA-approved for the treatment of post-operative inflammation and pain following ocular surgery.

Ehsan Sadri, MD, FACS, of Visionary Eye Institute in Newport Beach, California, sat down with Professor Emeritus Colin R. Green, PhD, DSc, University of Auckland, in Auckland, New Zealand, to learn more about a novel therapy in development for the treatment of keratoconus and other corneal ectasias.

Aflibercept biosimilars have cleared several hurdles on their way to marketplace

Push to identify biomarkers for earlier diagnosis, new therapeutic targets.

APP13007, according to the company, is the first product developed using Formosa’s proprietary APNT nanoparticle formulation platform.

The FDA has a 60-day filing review period to determine whether the NDA submission is complete and acceptable for review.

According to the company, the FDA approval strengthens its biosimilar position in the US market.

The agreement with give Apotex exclusive rights in Canada for the commercialization of APP13007.

According to the company, the Denali trial is evaluating NCX 470 safety and efficacy in patients with open-angle glaucoma or ocular hypertension and topline results continue to be expected in H2 2025

Therapeutics can prevent vision loss and neurodegeneration in patients.

NVK002 atropine 0.01% (Vyluma Inc.) “meaningfully slowed” myopia progression in myopic pediatric patients over a 36-month period.

According to Genentech, faricimab-svoa is the first and only syringe prefilled with an FDA-approved bispecific antibody to treat retinal conditions that can cause blindness.