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IVERIC bio announced the FDA completed its filing review and accepted the company’s new drug application (NDA) for avacincaptad pegol (ACP), a novel investigational complement C5 inhibitor for the treatment of geographic atrophy secondary to AMD. The NDA has been granted Priority Review with a Prescription Drug User Fee Act goal date of Aug. 19, 2023. The company also announced that, at this time, the FDA has not identified any potential review issues and is not currently planning to hold an Advisory Committee meeting for ACP.
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Ocuphire Pharma announced the FDA accepted the NDA for Nyxol (phentolamine ophthalmic solution 0.75%) for the treatment of pharmacologically induced mydriasis. The FDA assigned a Prescription Drug User Fee Act date of Sept. 28, 2023. If approved, Nyxol eyedrops will be the first prescription reversal drop available for patients in the United States. The NDA filing is supported by positive results from the comprehensive MIRA clinical program collectively involving over 600 subjects, including the MIRA-1 Phase 2b trial, MIRA-2 and MIRA-3 Phase 3 pivotal trials and MIRA-4 Phase 3 pediatric trial.
- Coherus BioSciences announced the Centers for Medicare and Medicaid Services published a new code pursuant to the company’s application for Healthcare Common Procedure Coding System (HCPCS) Q-codes. The HCPCS Q-code assigned to CIMERLI will be effective for patients administered CIMERLI on or after April 1, 2023. CIMERLI is the first FDA-approved biosimilar interchangeable with ranibizumab (Lucentis, Genentech) for all indications including neovascular (wet) AMD, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy and myopic choroidal neovascularization. COHERUS Solutions’ patient services hub is available to facilitate successful access and reimbursement.
- Visionix USA introduced its next-generation, multimodal OCT system, the Optovue Solix FullRange OCT, in the United States. The Optovue Solix offers SD-OCT with 120kHz ultra-high-speed scanning. It features FullRange Anterior 18x6.25 scans, new posterior high-density scan patterns that deliver more detail and better precision, integrated cameras for fundus, external photography and external IR imaging. Optovue Solix includes Visionix’s proprietary scans and software, and is available in two platforms — the FullRange, and fully featured, multimodal Solix system and Solix Essential for eyecare professionals who are not interested in FullRange or multimodality. Optovue Solix Essential offers Visionix’s proprietary scans and software with new advanced scan patterns.
- Eyenovia Inc. entered into a development collaboration agreement with Formosa Pharmaceuticals. The agreement seeks to combine Eyenovia’s Optejet dispensing technology with Formosa’s APNT nanoparticle formulation platform for the potential development of new topical ophthalmic therapeutics that employ the Optejet dispenser. The APNT platform reduces an active pharmaceutical ingredient’s particle size with high uniformity and purity, allowing penetration to relevant compartments in the eye, enhancing bioavailability.
- Harrow announced the launch of its patent-pending, next-generation compounded Atropine formulations, which are now available through Harrow’s wholly owned compounding and mail order pharmacy subsidiary, ImprimisRx. The companys says ImprimisRx next-generation Atropine formulations undergo validated analytical tests to ensure consistency, potency, and stability, do not contain preservatives or boric acid, have a physiologic pH of 5.5, and can be stored at room temperature for up to 180 days. Physicians can order these new formulations for $39 per 5mL bottle — either online at atropine.com or by calling or texting 615-437-4690 to speak to ImprimisRx Customer Service.
- Bruder Healthcare, a Hilco Vision company, announced an exclusive licensing agreement with Dry Eye Drink, the manufacturer of a portfolio of dry eye products and drink mixes. The drink formulations pair known anti-inflammatory, anti-oxidative and antibacterial ingredients with an electrolyte hydration formula to help with ocular inflammation, tear health and meibum oil gland production. Available in daytime and nighttime formulas in several flavors (mixed berries, orange and strawberry-lemonade), the product mixes contain green tea extract, turmeric, DHA/omega-3, Vitamin A, B3, B6, B12 and C.
- A new study conducted at Vanderbilt University Medical Center, in collaboration with the University of Iowa and Wheaton Eye Clinic, shows that the Olleyes VisuALL-K was able to effectively map out the visual field (VF) of pediatric patients while also increasing their satisfaction with the testing procedure. The patients found the headset more engaging and were more willing to complete the testing requested. VisuALL-K leverages virtual reality technology as part of a platform that can be used to map VF defects. It uses a cloud-based server and the Olleyes web application, which allows office staff to monitor and test anywhere in the clinic. The head-mounted device is adjustable to the smaller head of many pediatric patients, allowing for a better fit and comfort.
- Opthea Limited announced that Phase 2b study results of OPT-302, the company’s anti-VEGF-C/-D “trap” agent administered in combination with ranibizumab (Lucentis, Genentech) for the treatment of wet AMD, have been published online in Ophthalmology. The prospective, randomized, controlled Phase 2b trial of 366 treatment-naïve patients with wet AMD, demonstrated that monthly intravitreal administration of 2.0 mg OPT-302 with ranibizumab standard of care met the pre-specified primary efficacy endpoint of a statistically superior gain in visual acuity at 24 weeks compared to ranibizumab alone. Secondary outcomes were positive for the OPT-302 combination therapy, including more participants with gains in vision of 10 or more letters, improved anatomy of reduction in swelling and vascular leakage and a favorable safety profile. For more, see the study results here.
- REGENXBIO announced results from a Phase 2 bridging study evaluating the pharmacodynamics, safety and efficacy of RGX-314, using cGMP material produced by the company's NAVXpress bioreactor platform process. The results showed RGX-314 — a potential one-time treatment for wet AMD, diabetic retinopathy and other chronic retinal conditions delivered subretinally using cGMP material produced by the NAVXpress platform process — was well-tolerated and demonstrated a similar clinical profile to the initial adherent cell culture manufacturing process that was used in earlier trials of RGX-314. To support future commercialization of RGX-314, the cGMP material produced by the company’s NAVXpress platform process has been incorporated in the ongoing pivotal trials, ATMOSPHERE and ASCENT, for the treatment of wet AMD using RGX-314 delivered subretinally. For more, see the study results here.
- Aura Biosciences reported positive interim Phase 2 safety and efficacy data of belzupacap sarotalocan (Bel-sar) for the first-line treatment of patients with early-stage choroidal melanoma with suprachoroidal administration. The data presented with 9-10 months of follow up evaluating two key clinical endpoints: tumor control and visual acuity preservation using the suprachoroidal route of administration for the first-line treatment of patients with early-stage choroidal melanoma. Patients treated with three cycles of therapy showed a positive response to the therapy with 89-100% tumor control. In addition, the safety profile to date has been favorable with one patient losing visual acuity and no treatment-related SAEs or significant AEs. For more, see the study results here.
. - GenSight Biologics announced favorable safety data and encouraging efficacy signals at 1-year post-gene therapy administration for the PIONEER Phase 1/2 clinical trial evaluating GS030 for the treatment of retinitis pigmentosa in nine patients, with a follow-up up to 4 years (n=1). Three cohorts of three patients each were administered one of three doses of GS030-DP (5e10 vg; 1.5e11 vg; 5e11 vg) via a single intravitreal injection in their worst affected eye. Based on the good safety profile of GS030, the Data Safety Monitoring Board recommended selecting the highest dose (5e11 vg) for the extension cohort where patients are currently being recruited. For more, see the study results here.
- Celanese Corp., a global specialty materials and chemical company, announced an agreement with Johns Hopkins University’s Department of Ophthalmology to collaborate on a study of sustained drug delivery to the suprachoroidal space in the eye. A bioinert implant based on Celanese's VitalDose platform may provide sustained ocular drug delivery for greater than 6 months, offering an alternative approach for continuous dosing. The VitalDose Drug Delivery Platform independently has proven biocompatibility and achieves greater than 6 months release of mAbs, peptides, small molecules and RNAi therapeutics.