WHAT’S NEW IN DRY EYE AND OSD

The FDA accepted the new drug application (NDA) from Aldeyra Therapeutics for topical ocular reproxalap, a first-in-class investigational new drug candidate, for the treatment of the signs and symptoms of dry eye disease (DED). The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of Nov. 23, 2023.

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.

Glaukos Corp. announced promising initial results from the company’s Phase 2a clinical trial for GLK-301 (iLution), a sterile ophthalmic topical cream for DED. Topline Phase 2a outcomes for GLK-301 demonstrated improvement in the quality of tear film with corresponding improvement in quality of vision.

The FDA accepted Novaliq’s NDA for CyclASol (cyclosporine ophthalmic solution), an anti-inflammatory product for the treatment for the signs and symptoms of DED. The Agency completed the filing review of the CyclASol NDA and determined that the application is sufficiently complete to permit a substantive review. The PDUFA target action date set by the FDA is June 8, 2023.

Oyster Point Pharma announced the expansion of patient access to Tyrvaya (varenicline solution) Nasal Spray and continues to expand access for patients with DED. Tyrvaya is now covered by commercial prescription drug plans managed by the nation’s top three Pharmacy Benefit Manager Group Purchasing Organizations. Also new is expanded patient access programs.

Théa Pharma announced the availability of the iVIZIA line of over-the-counter eye-care products in the United States. The line includes lubricating eyedrops and eye gel and three options for daily hygiene of sensitive eyelids. iVIZIA eyedrops offer preservative-free extended relief and ocular surface protection to patients with any type of dry eye, including those who wear contact lenses.

IN THE NEWS

Apellis Pharmaceuticals announced the FDA approval of SYFOVRE (pegcetacoplan injection) for the treatment of geographic atrophy (GA) secondary to AMD. SYFOVRE is the first FDA-approved treatment for GA and is approved for GA patients with or without subfoveal involvement.

Regeneron Pharmaceuticals announced the FDA approved EYLEA (aflibercept) Injection to treat preterm infants with retinopathy of prematurity. The FDA also gave Priority Review status to EYLEA’s Biologic License Application for aflibercept 8 mg for treatment of wet AMD, diabetic macular edema and diabetic retinopathy.

The FDA completed its filing review and accepted IVERIC bio’s NDA for avacincaptad pegol, a novel investigational complement C5 inhibitor for the treatment of GA secondary to AMD. The NDA has been granted Priority Review with a PDUFA goal date of Aug. 19, 2023.

The FDA accepted Ocuphire Pharma’s NDA for Nyxol (phentolamine ophthalmic solution 0.75%) for the treatment of pharmacologically induced mydriasis. The FDA assigned a PDUFA date of Sept. 28, 2023. If approved, Nyxol eyedrops will be the first prescription reversal drop available in the United States.

Glaukos Corp. submitted an NDA to the FDA for iDose TR, a micro-invasive intraocular implant designed to continuously deliver therapeutic levels of a proprietary formulation of travoprost, a prostaglandin analog used to lower IOP, from within the eye for extended periods of time.

Bausch + Lomb announced the US introduction of PreserVision AREDS 2 Formula mini soft gels with OCUSorb. PreserVision AREDS 2, including the new OCUSorb formula, contain the exact nutrient formula recommended by the National Eye Institute.

Visionix USA introduced the Optovue Solix FullRange OCT in the United States. It offers SD-OCT with 120kHz ultra-high-speed scanning. Some features include FullRange Anterior 18x6.25 scans, new posterior high-density scan patterns, integrated cameras for fundus and external IR imaging.

Sight Sciences announced the US launch of the Ergo-Series of the OMNI Surgical System, a technology that facilitates surgeons’ ability to perform minimally invasive, implant-free glaucoma procedures in adults with primary open-angle glaucoma. It can be used before, in combination with, or following cataract surgery.