Therapeutics

In an interview with Ophthalmology Times, clinical trial investigator Zaina Al-Mohtaseb MD, noted the CLARA Phase 1/2 trial demonstrated the safety, efficacy, and simplicity of corneal endothelial cell injection therapy with a rho kinase inhibitor, offering a less invasive alternative to traditional corneal transplantation for treating corneal edema.

THRIVE-2 met all primary and secondary endpoints at the 15-week primary analysis timepoint after 5 infusions of veligrotug.

According to the company, its Phase 1/2 CLARA trial of AURN001 for corneal edema demonstrated significant dose-dependent efficacy, especially in the high-dose group, with favorable safety and tolerability profiles.

In the LIGHTHOUSE study, Atsena Therapeutics is evaluating ATSN-201 gene therapy for X-linked retinoschisis, leveraging AAV.SPR capsid for central retina transduction without foveal detachment risks.

The 14th annual Glaucoma 360 conference, co-founded by Adrienne Graves, PhD, and Andrew Iwach, MD, and hosted by Glaucoma Research Foundation, will be held from February 6-8, 2025, at the Westin St. Francis in San Francisco, California. The event will focus on the latest advancements in glaucoma care and encourage innovation and collaboration.

Tenpoint Therapeutics and Visus Therapeutics have merged to focus on aging-related ocular conditions, with key products including BRIMOCHOL PF for presbyopia and therapies for cataracts and geographic atrophy.

In an interview with Ophthalmology Times, Alon Kahana, MD, PhD, discusses interleukin-6 and its role in autoimmune diseases, particularly thyroid eye disease, noting that a promising alternative under clinical trial is pacibekitumab, an IL-6 ligand-blocking antibody.

Nona Biosciences has partnered with Kodiak Sciences to develop multi-target antibodies for ophthalmic diseases. Utilizing Nona's Harbour Mice platform, the collaboration aims to accelerate antibody discovery, focusing on innovative therapies for retinal and other eye conditions.

The company begins phase 1 trials of oral GAL-101, targeting amyloid beta aggregation. Promising safety and efficacy in ophthalmic models suggest potential for treating dry AMD, glaucoma, and neurodegenerative eye diseases.

BostonSight’s pilot study, published in Clinical Ophthalmology, explores the use of PROSE scleral lenses as a drug delivery system for cyclosporine 0.05% in treating dry eye disease, showing promising symptom relief and tolerability.

PolyActiva’s phase 2 clinical trial of its PA5108 glaucoma implant met efficacy and safety end points, demonstrating more than 20% reduction in IOP. The biodegradable implant offers sustained drug delivery for up to 26 weeks, addressing challenges of patient adherence and improving glaucoma treatment outcomes.

Melt Pharmaceuticals announced positive results from its Phase 3 study of MELT-300, a non-IV, non-opioid tablet for procedural sedation during cataract surgery. The results support a regulatory submission, with potential to revolutionize sedation practices in various medical specialties.

Emmecell announced positive Phase 1 extension study results for EO2002, a nonsurgical cell therapy for corneal edema. The therapy improved vision, reduced central corneal thickness, and demonstrated strong safety, offering an alternative to corneal transplants.

Retreatment rates are lower, with few orbit decompression procedures.

Livionex, recently announced a successful end-of-Phase 2 meeting with the FDA, supporting the advancement of C-KAD, a 2.6% EDTA ophthalmic solution, to a Phase 3 clinical study. In an interview with Ophthalmology Times, Randall Olson, MD, lead author and a Distinguished Professor at the University of Utah, Chair of the Department of Ophthalmology and Visual Sciences, and CEO of the John A. Moran Eye Center, discusses the ongoing research.

Sun Pharmaceutical presented Phase 4 data at ESCRS 2024 showing that cyclosporine ophthalmic solution 0.09% significantly improves dry eye disease symptoms and corneal staining in patients inadequately controlled on Restasis, with positive results observed through 12 weeks of treatment.

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.