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August 12, 2022
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AcuFocus Announces FDA Approval for the IC-8 Apthera Small Aperture IOL |
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AcuFocus has announced approval from the U.S. Food and Drug Administration (FDA) for its IC-8 Apthera intraocular lens (IOL) for the treatment of cataracts. In a press release the company said the Apthera IOL is the first and only non-toric extended depth of focus IOL approved for the 82% of cataract patients who have as much as 1.5 diopters of corneal astigmatism. AcuFocus said in the release “the Apthera IOL, with its proprietary small aperture technology, seamlessly provides excellent distance vision as well as clear intermediate and near vision, effectively mitigating the effects of presbyopia.” The press release said the company plans to begin with a limited commercial release of the Apthera IOL in the U.S. in the fall of 2022. More information can be found at https://www.biospace.com/article/releases/acufocus-announces-fda-approval-for-the-ic-8-apthera-intraocular-lens-the-first-and-only-small-aperture-lens-for-cataract-surgery/.
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FDA Approves Lenstec SBL-3 Multifocal Intraocular Lens for Cataract Surgery |
The Lenstec SBL-3 (segmented bifocal lens) is a next-generation asymmetric multifocal refractive intraocular lens (IOL) that according to the company provides patients with near, intermediate, and distance vision. Lenstec says the patented design allows for improved contrast sensitivity and minimized halo and glare commonly associated with other traditional 'concentric ring' multifocal IOLs. The release says the availability of the lens in 0.25 diopter power increments, along with the tightest industry tolerances (+/- 0.11 diopters from labeled power), assists surgeons in achieving the best refractive outcomes possible. More information can be found at https://www.prnewswire.com/news-releases/lenstec-sbl-3-multifocal-intraocular-lens-for-cataract-surgery-approved-by-fda-for-sale-in-the-us-301595737.html.
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Eyenovia Announces Michael Rowe as New CEO |
Eyenovia, who is developing a pipeline of late-stage microdose array print therapeutics including MicroLine for treatment of presbyopia, has announced the appointment of former chief operating officer Michael Rowe as the company’s new chief executive officer. The appointment followed a nationwide search and interviews with multiple candidates. Mr. Rowe has also been appointed to Eyenovia’s board of directors, increasing the board to nine seats. In a press release, Mr. Rowe said, “With the pending resubmission of our MydCombi NDA, the upcoming completion of our VISION-2 presbyopia trial, and the commencement of our manufacturing operations in Redwood City, CA, we have made substantial progress this year, and I look forward to working with my fellow board members and the rest of the leadership team to maintain this forward momentum.” Mr. Rowe served as the company’s chief operating officer since January 2021, having first joined the company in July 2018 as corporate vice president. More information can be found at https://www.globenewswire.com/en/news-release/2022/07/27/2486795/0/en/Eyenovia-Announces-Appointment-of-Ophthalmic-Industry-Veteran-Michael-Rowe-as-Chief-Executive-Officer-and-Board-Member.html.
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RxSight Files Shelf Registration Statement and Announces Equity Offering Program |
RxSight, Inc. announced in a press release that it has filed a $200 million shelf registration statement on Form S-3 with the Securities and Exchange Commission (SEC). Once declared effective by the SEC, the shelf registration statement would permit the company to sell up to $200 million in aggregate value of its common stock, preferred stock, debt securities, warrants, and/or units. The press release said the shelf registration statement is intended to provide the company with flexibility to access additional capital when market conditions are appropriate. The RxSight Light Adjustable Lens system is the only commercially available intraocular lens technology that enables doctors to customize and optimize visual acuity for patients after cataract surgery. The press release explained that as part of the shelf registration, RxSight also filed a prospectus supplement to sell, of the $200 million of securities being registered, up to an aggregate of $50 million of its common stock through an "at-the-market" offering. More information can be found at https://www.globenewswire.com/news-release/2022/08/08/2494314/0/en/RxSight-Inc-Files-Shelf-Registration-Statement-and-Announces-50-Million-At-The-Market-Equity-Offering-Program.html.
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Ocuphire Pharma Announces Presentations at Two Conferences |
Ocuphire Pharma, a biopharmaceutical company developing Nyxol for treatment of presbyopia, (both as a single agent and with low dose pilocarpine), has announced it is giving presentations at two healthcare banking conferences in August. Charlie Hoffmann, VP of corporate development and operations, and Ronil Patel, senior director of business development and market strategy will participate in a fireside chat at the Canaccord Genuity 42nd Annual Growth Conference, and founder and CEO Mina Sooch will present at the H.C. Wainwright 2nd Annual Ophthalmology Virtual and participate in a fireside discussion as well. More information can be found at https://www.ocuphire.com/news-media/press-releases/detail/379/ocuphire-pharma-announces-upcoming-presentations-at-two.
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Atia Vision Closing On $42m Series E Financing |
Atia Vision, a Shifamed portfolio company, is committed to improving patient outcomes through the development of a modular presbyopia-correcting intraocular lens (IOL). The company has announced in a press release the first close of a $42M Series E financing led by Cormorant Asset Management, with participation by The Capital Partnership, PA MedTech VC Fund, AMED Ventures and Shifamed angel investors. The release says funds will be used to expand the company's clinical program, scale its manufacturing capabilities, and expand the Atia Vision team. Atia says its modular IOL technology aims to address the limitations of current solutions, with innovation featuring a shape-changing, fluid-filled base, and a design that includes an exchangeable fixed power front optic. More information can be found at https://www.prnewswire.com/news-releases/atia-vision-a-shifamed-portfolio-company-to-close-on-42m-series-e-financing-301597164.html.
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