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

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.

Tarsus Added to NASDAQ Biotechnology Index

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.

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

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.

Aurion Biotech Wins Prestigious Prix Galien Startup Award

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.

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

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.

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

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.

IanTrek, Inc.

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.

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

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.

Aurion Biotech

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

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.