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Innovation finds its way into all areas of medtech, and ophthalmic treatments represent another burgeoning space. Implants, lenses and more comprise the space’s latest innovations, with a number of companies finding new ways to fix old problems. Here are five innovations in ophthalmic technology that have caught the eye of editors here at MassDevice: Johnson & Johnson Vision’s drug-eluting contact lens Johnson & Johnson Vision (NYSE:JNJ) Director of Clinica Science Dr. Brian Pall told MassDevice earlier this year that researchers considered the notion of delivering medication through contact lenses as far back as the 1960s. J&J Vision designed Acuvue Theravision with Ketotifen lenses as daily disposable contacts indicated to prevent ocular itch due to allergic conjunctivitis. They provide vision correction in patients who do not have red eyes and are suitable for contact lens wear. The lenses do not have more than 1.00 D of astigmatism. Each lens has a 19 μg dose. When placed, the lens has a release pro helps prevent the itch associated with ocular allergies. Whereas eye drops can be blinked out and may not reach the target tissue as effectively, the lens has a quick release in which the drug diffuses out in the first hour to be absorbed by ocular tissues. Over the ensuing hours, the remaining amount of the drug releases at a slower rate for sustained therapy, leading to a clinically proven duration of action that totals up to 12 hours. Since receiving FDA approval, J&J Vision made a series of other strides forward. Earlier this month, it launched its new Acuvue Oasys Max 1-day contact lenses and multifocal lenses for presbyopia. Then, reports in Ireland said the company is investing €100m in the expansion of its Plassey, Limerick, Ireland facility. It plans to use the investment to expand its manufacturing capability. J&J Vision intends to introduce fully automated flexible manufacturing lines with the added funds at the contact lens manufacturing site. Alcon’s intraocular lenses In March, Alcon (SIX/NYSE:ALC) launched its Clareon family of intraocular lenses (IOLs) in the U.S. Clareon lenses feature a glistening-free IOL material. This provides the lowest levels of haze and subsurface nanoglistenings (SSNGs) compared to leading competitors’ IOLs, the company says. Alcon also made its Clareon Monofocal available in the next-generation, automated, single-use delivery system called AutonoMe. Clareon Toric will be available in the U.S. later this year. Alcon plans to roll out the Clareon family of IOLs in international markets throughout 2022 and 2023. The company doesn’t just offer the Clareon intraocular lenses. Its AcrySof IQ PanOptix trifocal IOL won FDA approval in August 2019. AcrySof IQ PanOptix is one of the only trifocal devices in the U.S. for patients undergoing cataract surgery. The device offers a combination of improved near, immediate and distance vision. It significantly reduces the wearer’s need for glasses after surgery, according to Alcon. AcrySof IQ PanOptiz registered among the nominees for the 2022 Prix Galien International Awards earlier this year. Glaukos’ trio of ophthalmic drug delivery devices Glaukos (NYSE:GKOS) has three intriguing ophthalmic devices in its pipeline: iDose, iStent and iPrime. iDose contains a novel formulation of travoprost, a prostaglandin analog used to reduce intraocular pressure (IOP). Glaukos designed it to continuously release therapeutic levels of medication for at least one year. Once all travoprost is released, iDose TR is removed and replaced with an implant. This potentially offers an alternative to daily eye drop treatment. Earlier this month, Glaukos announced positive outcomes from two Phase 3 pivotal trials for its iDose TR system. Last year, Glaukos submitted a supplemental premarket approval application to the FDA for iStent Infinite. The iStent Infinite is similar to its two-stent iStent Inject W trabecular micro-bypass system that holds FDA approval. Finally, the iPrime viscodelivery system garnered FDA 510(k) clearance at the beginning of this year. The sterile, single-use, minimally invasive device delivers viscoelastic fluid during ophthalmic surgery. Sight Sciences’ surgical systems for glaucoma, dry eye disease Sight Sciences (Nasdaq:SGHT) develops two innovative ophthalmic systems: the Omni surgical system and the TearCare system. Last month, the company reported 36-month data supporting the use of the Omni surgical system. Sight Sciences evaluated the Omni system in canaloplasty followed by trabeculectomy. The system achieved a mean reduction in IOP of at least 20% for all 26 patients (38 eyes) at 36 months follow-up. TearCare, which holds FDA 510(k) clearance, applies localized heat therapy to adult patients. It treats evaporative dry eye disease due to meibomian gland dysfunction (MGD). The technology enables office-based clearance of gland obstructions by physicians to address the leading cause of dry eye disease. Study results from 2020 for the wearable eyelid technology demonstrated its safety and efficacy. Bausch + Lomb, Clearside Biomedical’s injectable suspension therapy In October 2019, Bausch + Lomb and Clearside Biomedical agreed to a licensing deal worth up to $76 million. The deal granted Bausch an exclusive license to develop, manufacture, distribute, promote, market and commercialize the SCS Microinjector suprachoroidal injection device. Clearside Biomedical designed the Xipere triamcinolone acetonide suprachoroidal injectable suspension therapy with a proposed indication for treating macular edema associated with uveitis, a form of eye inflammation. It represents the first and only FDA-approved therapy for suprachoroidal use in such treatment. In the deal between the two companies, Bausch agreed to pay $5 million upfront. It also includes additional payments worth up to $15 million after achieving specified pre-launch development and regulatory milestones. There is also $56 million available in other milestone payments related to regulatory approvals for additional indications and sales goals. It will be worth watching if anything else comes out of the partnership on the SCS Microinjector technology.

Nov. 15, 2021 11:00 UTC SHORT HILLS, N.J.--(BUSINESS WIRE)-- Bayshore Pharmaceuticals, LLC is pleased to introduce three new FDA-approved products to their expanding portfolio. Metolazone Tablets USP, 2.5mg, 5mg and 10 mg, is the generic equivalent of Zaroxolyn Tablets. It is available by prescription only and is indicated for the treatment of high blood pressure and fluid retention. Etodolac Immediate Release Tablets USP, 400 mg and 500 mg, is the generic equivalent of Lodine Tablets. Etodolac is a nonsteroidal anti-inflammatory drug and only available by prescription. Ketotifen Fumarate Ophthalmic Solution, 0.035% (OTC & RX) is the generic equivalent of Zaditor. It is an antihistamine that is indicated for the treatment of itchy eyes. Ketotifen is Bayshore Pharmaceutical’s first ANDA approved product that is available by prescription or as an OTC in the Bayshore Label. “Bayshore is very proud to bring these internal R&D projects through to FDA approval and commercialization. These efforts further exemplify our focus on balancing internally developed products with our continued partnerships with manufacturing partners such as Beximco Pharmaceuticals, in which we can utilize our trade relationships to market & distribute ANDA’s for those companies not set up do so directly,” says Mark Moshier, President of Bayshore Pharmaceuticals. About Bayshore Pharmaceuticals: Bayshore Pharmaceuticals, LLC was established in 2011 in the centrally located area of Short Hills, NJ. As a full-service Sales & Distribution company focusing on FDA-approved generic pharmaceuticals, Bayshore used its extensive knowledge and experience in global API and Finished Dosage Form manufacturing to differentiate itself from other Generic Pharmaceutical Sales & Marketing organizations. In addition to developing its wholly-owned portfolio of generic products, Bayshore successfully utilized its longstanding industry relationships to augment its business by marketing other pharma manufacturer’s ANDA products under the same Bayshore label. With a strong emphasis on Project Management and Supplier & Customer transparency, Bayshore, along with our global manufacturing partners, maintains the highest level of product quality, in full compliance with current Good Manufacturing Practices (cGMP). This mission has allowed Bayshore to become one of the most service-oriented and reliable supply partners in the industry. View source version on businesswire.com: Contacts Mark Moshier, President (973) 315-1819 Dena Mando, Vice President Sales & Marketing (973) 315-1824 Source: Bayshore Pharmaceuticals View this news release online at: