Therapeutics

The FDA has set a PDUFA target action date of October 23, 2025, for the low-dose atropine formulation.

Tarcocimab is an investigational anti-VEGF therapy built on Kodiak's proprietary antibody biopolymer conjugate (ABC) platform.

Clinician highlights a novel complication of atropine treatment in a teenage patient.

According to Apellis and Sobi, pegcetacoplan (Aspaveli) first received marketing authorisation for treatment of paroxysmal nocturnal hemoglobinuria.

Patients’ near visual needs is important when prescribing medications for glaucoma treatment

Alice T. Epitropoulos, MD, FACS, outlines her approach to managing evaporative dry eye. This includes diagnosing meibomian gland dysfunction, using thermal pulsation to clear gland blockages, and ensuring long-term results with advanced treatments and patient education.

The primary safety endpoint was carried out through the percentage of patients with shift from normal (at baseline) to abnormal in any electrocardiogram (ECG).

The trial is evaluating GAL-101 eye drops in patients with geographic atrophy, an advanced form of dry AMD.

Alon Kahana, MD, PhD, discusses the role of interleukin-6 in thyroid eye disease and the potential of tourmaline Bio's IL-6 inhibitor therapy.

Electrical stimulation therapy is being explored as a potential treatment to enhance neuroplasticity and improve visual function in optic neuropathy patients. Clinical trials show promising results in visual field improvements, though further research is needed on long-term efficacy and quality of life.

According to Iridex Corp., the study confirms MicroPulse TLT's sustained safety and efficacy in managing glaucoma, reducing intraocular pressure and medication reliance with minimal complications over 5 years.

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.

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.

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.

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.