| Click Here to view online. |
 |
|
|
| March 9, 2022 |
Kala Announces EYSUVIS Now Covered on UnitedHealthcare and Cigna Medicare
|
| Advertisement |
 |
Kala Pharmaceuticals has announced that UnitedHealthcare, one of the largest commercial health care plans in the United States, covering approximately 13 million lives, has added EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% as a covered brand on its commercial formularies effective March 2022. EYSUVIS now has coverage for approximately 118 million lives, or 70% of all commercial lives. Kala also announced that Cigna Medicare has added EYSUVIS as a preferred brand effective February 2022, adding an additional 1.9 million Medicare lives. EYSUVIS now has Medicare preferred coverage for select plans with Express Scripts, Prime Therapeutics, and Cigna. Total EYSUVIS Medicare coverage is now approximately 7.1 million lives, or 15% of all Medicare lives. EYSUVIS became commercially available in January 2021 as the first and only FDA-approved medicine for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease. More information can be found at https://investors.kalarx .com/news-releases/news-release-details/kala-pharmaceuticals-announces-eysuvisr-now-covered. |
DORC International Launches EVA NEXUS Platform
|
| DORC International is launching EVA NEXUS, which the company says is “the result of close collaboration with surgeons worldwide, combined with market leading technology for superior performance, efficiency and control in retina, cataract, and combined surgery.” EVA NEXUS introduces multiple innovations in surgical performance and efficiency including SmartIOP, which combines with the existing EquiPhaco technology for optimized control in cataract surgery; EVA AVETA, a ground-breaking trocar cannula system; and EVA INICIO, the first approved micro-injection system. During the limited release phase, leading surgeons have endorsed the system, performing over 1500 surgical procedures with EVA NEXUS. The first randomized controlled trial of 250 cases with EVA NEXUS will be completed by March 2022. |
Alcon Launches Clareon Portfolio of IOLs in the U.S.
|
| Alcon has the launched the Clareon family of intraocular lenses (IOLs) in the United States. The lenses utilize Alcon’s most advanced IOL material, and Alcon says they deliver consistent visual outcomes and lasting exceptional clarity. The company says the clarity comes from use of a glistening-free IOL material that has among the lowest levels of haze and subsurface nanoglistenings compared to leading competitor IOLs. The Clareon portfolio leverages many of the same design characteristics and optics as Alcon’s leading IOLs. Clareon is designed to offer sharp, crisp vision with a proprietary edge designed to help reduce glare and posterior capsular opacification. The lens’ unique and proven STABLEFORCE haptics provide superior axial and rotational stability. Clareon IOLs are inserted using the next-generation, reusable Clareon Monarch IV delivery system, which was designed specifically for the new Clareon material and provides precise and controlled implantation. More information can be found at https://www.alcon.com/media-release/alcon-strengthens-leadership-iol-innovation-launch-clareon-portfolio-us. |
LENSAR Announces U.S. Food and Drug Administration Acceptance of 510(k) Submission for ALLY
|
| LENSAR has announced that the U.S. Food and Drug Administration (FDA) accepted its 510(k) submission for its next-generation ALLY adaptive cataract treatment system for substantive review. The submission seeks marketing clearance for the ALLY adaptive cataract treatment system and is the first stage of a planned, two step commercial release strategy. As part of this strategy, the company plans to submit an additional 510(k) application seeking clearance for the phacoemulsification features within the integrated ALLY system later in 2022. LENSAR expects to launch ALLY in the second half of 2022, if cleared. More information can be found at https://www.biospace.com/article/releases/lensar-announces-u-s-food-and-drug-administration-acceptance-of-510-k-submission-for-ally/. |
Théa Completes its Acquisition of Akorn’s Branded Ophthalmic Products
|
| Théa Pharma Inc. has announced the completion of its previously announced acquisition of seven branded ophthalmic products from Akorn Operating Company LLC. The transaction expands Théa’s role as an important provider of products designed to meet the needs of eye care professionals across the United States. Under the deal, Théa acquired seven products including established glaucoma therapies Zioptan, Cosopt, Cosopt PF, Betimol, along with Azasite, Akten, and the ocular surface repair agent AcellFX. Théa acquired the Akorn portfolio as part of a larger commitment to developing cutting-edge products for the U.S. market in areas of unmet need. Also this month, launch activities have begun for its evidence-based line of iVIZIA OTC products for dry eye and eyelid hygiene being distributed by Similasan Corporation, a Colorado-based company known for its natural products for eye, ear, sinus, and cold relief. In addition, Théa filed its first New Drug Application (NDA) with the FDA for a version of the glaucoma treatment latanoprost on February 18, 2022. During a short post-closing transition period, Akorn will provide services to Théa, with respect to business operations and management. Business will continue as usual, with Théa providing updates as needed to all key stakeholders. More information can be found at https://www.businesswire.com/news/home/20220309005206/en/Th%C3%A9a-Completes-its-Acquisition-of-Akorn%E2%80%99s-Branded-Ophthalmic-Products-Expanding-its-Presence-in-the-United-States-Eye-Care-Industry. |
Ocuphire Completes Enrollment in MIRA-4 Pediatric Safety Trial Evaluating Nyxol for Reversal of Mydriasis
|
| Ocuphire Pharma has announced it has completed enrollment in the MIRA-4 trial evaluating the safety and efficacy of Nyxol eye drops to reverse pharmacologically-induced mydriasis (RM) in 23 pediatric subjects. Ocuphire worked closely with Oculos Development Services and the 2 U.S. investigational sites to accomplish this milestone in 2 months. MIRA-4 is part of a comprehensive MIRA clinical program to develop Nyxol for RM and as agreed with FDA under the Pediatric Research Equity Act. This includes the evaluation in pediatric patients as young as 3 to 11 years old in order to include Nyxol use for this pediatric population. In February, Ocuphire announced completion of enrollment in the MIRA-3 Phase 3 clinical trial investigating Nyxol for RM in adults 18 and older and children of ages 12-17 years. If successful, the company anticipates submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Nyxol for RM in late 2022. More information can be found at https://www.globenewswire.com/news-release/2022/03/08/2398849/0/en/Ocuphire-Completes-Enrollment-in-MIRA-4-Pediatric-Safety-Trial-Evaluating-Nyxol-for-Reversal-of-Mydriasis.html. |
|
| Follow us: |
|
|
|
