News – Page 2 – Visionary Ventures

Mar82023

ONL Therapeutics Closes First Tranche of $15 Million Series C Financing to Advance Lead Compound into Phase 2 Clinical Trial

News, ONLBy Garrett Hamontree March 8, 2023

ONL Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel therapies for protecting the vision of patients with retinal disease, today announced it has closed on the first tranche of a $15 million Series C Preferred Stock financing round. Proceeds from the financing will primarily support the advancement of ONL1204 Ophthalmic Solution into a Phase 2 clinical trial in patients with macula-off rhegmatogenous retinal detachment (RRD). We expect to initiate this new U.S.-based Phase 2 study in acute retinal detachment next quarter and to continue to generate data throughout the year from our two ongoing chronic Phase 1b studies in geographic atrophy (GA) associated with age-related macular degeneration and progressing open-angle glaucoma (OAG) that are being conducted in Australia and New Zealand.

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Feb212023

FDA Accepts Orasis Pharmaceuticals’ New Drug Application for CSF-1 for the Treatment of Presbyopia

News, OrasisBy Garrett Hamontree February 21, 2023

Orasis Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for investigational CSF-1 (low dose pilocarpine hydrochloride 0.4%). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 22, 2023.

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Jan82023

RxSight Announces 117% Revenue Growth in 2022

News, RxSightBy Garrett Hamontree January 8, 2023

Preliminary unaudited fourth quarter 2022 revenue is expected to be approximately $16.1 million, representing growth of approximately 91% compared to the prior year period.

Preliminary unaudited 2022 fiscal year revenue is expected to be approximately $49.0 million, representing growth of approximately 117% compared to the prior year.

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Jan42023

Orasis Pharmaceuticals Submits New Drug Application for Investigational Novel Eye Drop Candidate

News, OrasisBy Garrett Hamontree January 4, 2023

Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on developing a unique eye drop to improve near vision for people with presbyopia, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for investigational CSF-1 (low dose pilocarpine hydrochloride 0.4%). The NDA is based on data from the Phase 3 NEAR-1 and NEAR-2 clinical trials, involving more than 600 patients, which evaluated the efficacy and safety of CSF-1. Both trials met their 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. The most common treatment-related adverse events of headache and instillation site 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.

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Dec162022

Tarsus Added to NASDAQ Biotechnology Index

News, TarsusBy Garrett Hamontree December 16, 2022

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 Tarsus will be added to the NASDAQ Biotechnology Index® (NASDAQ: NBI), effective December 19, 2022.

The NASDAQ Biotechnology Index is designed to track the performance of a set of biotechnology and pharmaceutical companies listed on The Nasdaq Stock Market. Companies in the Index must meet eligibility requirements, including minimum market capitalization and average daily trading volume, among other criteria. The Index is evaluated annually and serves as the basis for the iShares NASDAQ Biotechnology Index Fund (NASDAQ: IBB). Because of this designation, shares of Tarsus will be included in the portfolios of NASDAQ Biotechnology Index funds.

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Nov302022

Re-Vana Therapeutics Raises $11.9 Million in Series A Financing

News, Re-VanaBy Garrett Hamontree November 30, 2022

Re-Vana Therapeutics Ltd, a privately-held specialty drug delivery company developing sustained-release therapeutics for the treatment of vision-threatening ocular diseases, today announced the closure of its Series A round with $11.9 million in funding, an oversubscription of $4 million. The financing was led by Visionary Ventures. Additional investors include ExSight Ventures, InFocus Capital Partners and existing U.K. investors, Qubis Ltd, Co-Fund NI, and TechStart Ventures. Re-Vana has demonstrated that its groundbreaking platform can achieve 6 months or greater sustained delivery of an anti-VEGF biologic at therapeutically-relevant levels with high drug loading, controlled burst release, and a favorable degradation profile.

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Oct282022

Aurion Biotech Wins Prestigious Prix Galien Startup Award

Aurion, NewsBy Garrett Hamontree October 28, 2022

Visionary portfolio company, Aurion Biotech, whose mission is to restore vision to millions of patients with its life-changing regenerative therapies, today announced it has won the prestigious Prix Galien Award for Best Startup in Biotech / Pharma. The Galien Foundation, the premier global institution dedicated to honoring innovators in life sciences, fosters, recognizes, and rewards excellence in scientific innovation to improve the state of human health. Aurion Biotech received the Best Start-up in Biotech / Pharma award, one of six different award categories, and was chosen from more than 146 products from 129 nominee companies, spanning 14 therapeutic areas. According to the Galien Foundation, the Prix Galien is regarded as the equivalent of the Nobel Prize in biopharmaceutical research.

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Oct62022

TearClear Announces Positive Top-Line Results from Clear Phase 3 Study for Treatment of Glaucoma

News, TearClearBy Garrett Hamontree October 6, 2022

TearClear, an ophthalmic pharmaceutical company that transforms trusted drugs into branded best-in-class therapies, announced today that the company’s lead product, TC-002 (latanoprost ophthalmic solution 0.005%) met the primary and all secondary endpoints in the CLEAR Phase 3 pivotal trial. With these results, TearClear plans to file a New Drug Application (NDA) with the US Food and Drug Administration (FDA) in the first quarter of 2023. Upon approval, TC-002 will offer patients the first and only means of delivering preservative-free doses of latanoprost from conventional multi-dose bottles.

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Sep72022

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

News, TarsusBy Garrett Hamontree September 7, 2022

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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Aug302022

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

Iantrek, NewsBy Garrett Hamontree August 30, 2022

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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