Orasis Pharmaceuticals Announces Novel Corrective Eyedrop for Presbyopia, Qlosi™ (pilocarpine hydrochloride ophthalmic solution) 0.4%, Now Available to Prescribe in the U.S.

News, Orasis

Orasis Pharmaceuticals, an ophthalmic pharmaceutical company delivering solutions to reshape vision possibilities, today announced that Qlosi™ (pilocarpine hydrochloride ophthalmic solution) 0.4%, a novel, corrective prescription eye drop for the treatment of presbyopia, or age-related blurry near vision, in adults is now available to prescribe in the U.S.

Qlosi’s proprietary EyeQ Formulation™ maximizes efficacy while minimizing side effects by balancing the lowest approved concentration of pilocarpine at a near neutral pH for optimal bioavailability, is preservative-free in single-use vials, and includes lubricants (HA & HPMC) for comfort. Patients have the flexibility of using one drop of Qlosi in each eye for improved near vision for a specific occasion or activity, and up to two drops per day for an extended effect, lasting up to eight hours.

Sydnexis Announces Positive CHMP Opinion in Europe for SYD-101 for Slowing the Progression of Pediatric Myopia

News, Sydnexis

Sydnexis, Inc. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion for its proprietary low-dose atropine formulation, SYD-101, for slowing the progression of pediatric myopia. Santen SA licensed the rights from Sydnexis to commercialize SYD-101 under the brand name Ryjunea® in the regions of Europe, Middle East, and Africa (EMEA). Santen SA is the Switzerland-based affiliate of Santen Pharmaceutical Co., Ltd., a Japan-based company specialized in eye health, offering innovative products and services in over 60 countries worldwide.

Alcon Acquires Majority Interest in Aurion Biotech, Inc. to Advance Innovative Cell Therapy for Corneal Endothelial Disease

Aurion, News

Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced it has acquired a majority interest in Aurion Biotech, Inc., a clinical-stage company developing advanced cell therapies to treat eye diseases. Aurion will operate as a separate company with full support from Alcon to advance its clinical-stage allogeneic cell therapy asset, AURN001, into Phase 3 for corneal edema secondary to corneal endothelial disease during the second half of 2025. Aurion will have access to the broader R&D, regulatory, medical ophthalmic and commercial capabilities of Alcon.

Santen Announces Sydnexis European Pivotal Data

News, Sydnexis

Santen announced Sydnexis SYD-101 Phase III clinical data and is expecting European approval in early 2025 for the treatment of pediatric progressive myopia. Santen licensed SYD-101 for Europe, Middle East, and Africa from Sydnexis. Sydnexis is also seeking approval for the United States. Pediatric progressive myopia impacts ~28 million patients in the United States alone. Left untreated leads to immediate loss of QOL for patients and increases vision risks later in life: cataract (5x), glaucoma (14x), retinal detachment (44x), & myopic maculopathy (348x).

Aurion Biotech Announces Positive Topline Data for Phase 1/2 Clinical Trial of AURN001, an Allogeneic Cell Therapy Product Candidate for the Treatment of Corneal Edema Secondary to Corneal Endothelial Dysfunction

Aurion, News

Aurion Biotech, Inc. (Aurion Biotech) announced topline data from its Phase 1/2 clinical trial (CLARA) of AURN001, an allogeneic cell therapy product candidate for the treatment of corneal edema secondary to corneal endothelial dysfunction. For the primary endpoint, a dose-dependent response was observed in the three AURN001 arms, with a statistically significant improvement in the high-dose AURN001 arm (50% of responders, p=0.020), as compared to the Y-27632-only arm (14.3%). A key secondary endpoint, change in BCVA at six months, showed a statistically significant improvement for the high-dose AURN001 arm (p=0.002), as compared to the Y-27632-only arm (using the full analysis set population (LOCF, LS mean2)). Additionally, a dose response was observed in the three AURN001 arms. For the key secondary endpoint, change in CCT at six months, there was a statistically significant improvement for the high-dose AURN001 arm (p=0.012), as compared to the Y-27632-only arm (using the full analysis set population (LOCF, LS Mean)).

Orasis Pharmaceuticals Completes $78 Million Financing to Support Commercial Launch of Qlosi™

News, Orasis

Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on reshaping vision possibilities, today announced the completion of a $78 million financing to support the commercial launch of Qlosi™ (pilocarpine hydrochloride ophthalmic solution) 0.4%, a novel corrective eye drop for the treatment of presbyopia in adults. The Series D financing included a $68 million equity component, co-led by Arboretum Ventures and Johnson & Johnson Innovation – JJDC, Inc., along with participation from Catalio Capital Management, Freepoint Capital Group, and returning investors—Visionary Ventures, Bluestem Capital, SBI (Japan) Innovation Fund, Sequoia Capital, and Maverick Ventures, as well as other individuals. Concurrent with its equity raise, Orasis has secured $15 million in structured capital from Catalio Capital Management, of which $10 million will be drawn at closing.

“The FDA approval of QLOSI marks a tremendous milestone for Orasis as we continue our mission to provide a flexible treatment option for the millions of people in the U.S. living with presbyopia, or blurry near vision,” said Elad Kedar, Chief Executive Officer of Orasis Pharmaceuticals. “I am grateful to the Orasis team, our strategic partners, clinical investigators, and patients who participated in our clinical trials, all of whom made this achievement possible.”

QLOSI (pronounced CLOH-see) is a prescription eye drop that can be used daily, or as needed, up to twice per day. QLOSI demonstrated efficacy 20 minutes after administration and can last up to 8 hours, as measured on day 15, to improve near vision without impacting distance or night vision. QLOSI is a preservative-free formulation of pilocarpine, an established eye care therapeutic, designed to achieve an optimal balance between efficacy, safety, and comfort.

Iantrek Announces Publication of Results of its Bio-interventional Uveoscleral Outflow Technology in Patients with Open-Angle Glaucoma

Iantrek, News

Iantrek, Inc., a venture-backed, medical technology company pioneering next-generation bio- and micro-interventional approaches for the treatment of ophthalmic diseases, today announced that clinical results of its uveoscleral outflow technology in 243 eyes with open-angle glaucoma were published in the peer-review Journal of Clinical Medicine. Topline results were presented earlier this year at the 2024 American Society of Cataract and Refractive Surgery Annual Meeting in Boston, MA.

ONL Therapeutics Closes $65 Million In Oversubscribed Series D Financing

News, ONL

ONL Therapeutics has secured $65M in Series D financing to advance the development of ONL1204 Ophthalmic Solution with the initiation of a Phase 2 global study for the treatment of geographic atrophy (GA) associated with dry age-related macular degeneration (AMD). Johnson & Johnson Innovation – JJDC, Inc. led the round that was backed by a consortium of investors that included Bios Partners, Novartis Venture Fund, and Visionary Ventures, amongst others.

Pelage Pharmaceuticals AdvancesClinical Program with First PatientsDosed in Phase 2 Study for Hair Lossand GV-Led $14M Series A-1

News, Pelage

Pelage Pharmaceuticals, a clinical-stage regenerative medicine company pioneering a new generation of treatments for hair loss, today announced that the first patients have been dosed in its Phase 2a clinical trial evaluating the safety and efficacy of PP405. Pelage also raised a $14 million Series A-1, led by GV with support from Main Street Advisors, Visionary Ventures, and YK BioVentures, following an initial $16.75 million Series A financing announced in February 2024. The Series A-1 follows positive Phase 1 data, which demonstrated proof of mechanism and target engagement in patients with androgenetic alopecia, supporting a Phase 2 study.