Therapeutics

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.

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.

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.