Tarsus Submits New Drug Application to the FDA for TP-03 for the Treatment of Demodex Blepharitis

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IRVINE, Calif., Sept. 07, 2022 (GLOBE NEWSWIRE) — Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TP-03 (lotilaner ophthalmic solution, 0.25%) for the treatment of Demodex blepharitis. Demodex blepharitis is a highly prevalent eyelid margin disease that does not have any FDA-approved treatment options. The NDA submission includes the positive results from the two pivotal trials (Saturn-1 and Saturn-2) collectively involving more than 800 patients in which TP-03 met all endpoints and was well-tolerated.

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IanTrek, Inc.

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Iantrek, Inc. is an ophthalmic medical device company developing advanced micro-interventional surgical technologies. The CycloPen™ micro-interventional system targets the suprachoroidal outflow pathway – an established therapeutic target where MIGS micro-stent interventions have demonstrated significant and sustained outflow enhancement with the majority of patients achieving IOP reduction of 20% or more.

Iantrek Raises $23M Series B Financing to Advance Next Generation Ophthalmic Micro-Interventional Technologies

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Iantrek, Inc., a medical device company founded by ophthalmic innovator Dr. Sean Ianchulev, announced the closing of a $23M Series B financing. The oversubscribed financing was led by institutional investors Visionary Ventures and Sectoral Asset Management, Inc. The capital will be used to initiate clinical introduction and post-marketing studies of Iantrek’s Micro-Interventional Glaucoma Surgical (MIGS) devices in the United States. Iantrek is the only MIGS company with FDA-registered technologies designed to address both natural aqueous outflow pathways, trabecular and suprachoroidal. Earlier this year, the company unveiled its breakthrough CycloPen™ micro-interventional system targeting the suprachoroidal outflow pathway – an established therapeutic target where MIGS micro-stent interventions have demonstrated significant and sustained outflow enhancement with the majority of patients achieving IOP reduction of 20% or more. The first cases in the US using Iantrek’s suprachoroidal technology were performed earlier this month. The company will present long-term clinical outcomes at the annual meeting of the American Academy of Ophthalmology in Chicago later this year.

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Aurion Biotech

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Aurion Biotech is a clinical-stage biotech company whose mission is to restore vision to millions of patients with its life-changing regenerative therapies. Its first product candidate is for the treatment of corneal edema secondary to endothelial dysfunction, and is one of the first clinically validated cell therapies for corneal care.

Orasis Pharmaceuticals Announces Positive Phase 3 Topline Results

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In both trials, CSF-1 met its primary and key secondary endpoints on Day 8, achieving statistically significant 3-line or more gain in distance-corrected near visual acuity (DCNVA), and no loss of 1-line or more in distance visual acuity. Pooled across the two studies, 40% and 50% of participants demonstrated these gains 1-hour post-dose 1 and 1-hour post-dose 2 respectively (P<0.0001). CSF-1 also achieved statistically significant 3-line improvement at all measured time points on Days 1 and 15. On Day 15, participants achieved statistically significant 3-line or more improvement in DCNVA as early as 20 minutes and up to 8 hours post-dose 1. In addition, CSF-1 demonstrated an excellent tolerability and safety profile, with comparable redness and comfort versus vehicle, validating the preservative-free presentation and proprietary formulation of CSF-1. The most common treatment-related adverse events of headache and instillation sight pain occurred in only 6.8% and 5.8% of participants, respectively. Of all CSF-1 participants, only 2.6% reported moderate treatment-related adverse events. All other adverse events were mild.

Aurion Biotech Raises $120 Million from Deerfield Management, Petrichor, Flying L Partners, Falcon Vision/KKR, and Visionary Ventures

Aurion, News

Aurion Biotech, whose mission is to restore vision to millions of patients with its life-changing regenerative therapies, today announced it has secured a $120 million financing with top-tier biotech and ophthalmology investors. The financing was led by Deerfield Management, and included existing investors Petrichor Healthcare Capital Management, Flying L Partners, Falcon Vision, an ophthalmology-focused investment platform supported by KKR, and Visionary Ventures, a leading ophthalmology-focused venture fund creating value with better insight. Alcon also participated in the financing. Funds will be disbursed to the Company based on the achievement of key clinical and operational milestones.

Sydnexis Secures $45 Million Series B Financing Led by Visionary Ventures and Blue Stem Capital

News, Sydnexis

Visionary Ventures led a $45MM round into its 12th portfolio company, Sydnexis. Sydnexis is a clinical stage biopharmaceutical company with a proprietary formulation of low dose atropine for the treatment of progressive myopia, today announced the completion of a $45 million Series B financing led by Visionary Ventures, Blue Stem Capital, and SC Master Fund, with participation from existing investors RA Capital Management, Longitude Capital, and Medicxi. The financing will be used to fund Sydnexis’ lead candidate, SYD-101, through completion of the fully enrolled pivotal Phase 3 STAAR study for the treatment of progressive myopia in children.

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Sydnexis

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Sydnexis is a San Diego based clinical stage pharmaceutical company currently in the middle of a pivotal Phase 3 study, focused on the development of a novel proprietary formulation of low dose atropine for the treatment of myopia. Myopia is a growing public health challenge worldwide that’s expected to affect 5 billion people by the year 2050.