ONL Therapeutics Announces Randomization of First Patient in Global Phase 2 GALAXY Trial of Xelafaslatide (ONL1204) in Patients with Geographic Atrophy (GA) Associated with Dry AMD

News, ONL

ONL Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel therapies for protecting the vision of patients with retinal disease, today announced that the first participant has been randomized in the company’s Phase 2 GALAXY trial. GALAXY is a global Phase 2 clinical trial designed to evaluate the efficacy and safety of xelafaslatide (formerly ONL1204) in patients with geographic atrophy (GA) associated with dry age-related macular degeneration (AMD).

Pelage Pharmaceuticals Announces $120 Million Series B Financing to Advance Regenerative Medicine Treatments for Hair Loss

News, Pelage

Pelage Pharmaceuticals, a clinical-stage regenerative medicine biotechnology company, today announced the close of a $120 million Series B financing co-led by ARCH Venture Partners and GV (Google Ventures), with participation from existing investors including Main Street Advisors, Visionary Ventures, and YK Bioventures. The financing will support the continued advancement of Pelage’s lead program, PP405, a topical small molecule designed to reactivate dormant hair follicle stem cells, offering a potential first-in-class approach for both men and women experiencing hair loss.

Iantrek Raises $42 Million Series C to Launch AlloFlo

Iantrek, News

Iantrek, Inc., a pioneer in bio-interventional ophthalmic surgery (BIOS), today announced the close of a $42 million Series C financing round, which will fund the U.S. commercial launch of AlloFlo™ Uveo, a first-of-its-kind surgical solution targeting the uveoscleral pathway, as well as broader pipeline expansion. The Series C was led by U.S. Venture Partners (USVP), joined by aMoon Fund, along with existing investors Visionary Ventures, Sectoral Asset Management, Radius Special Situations Fund, and Civilization Ventures.

Tarsus Reports $102.7 Million Sales in Second Quarter 2025

News, Tarsus

“As we approach the two-year anniversary of the XDEMVY launch, we have delivered our strongest quarter to date with over $100 million in net sales and established XDEMVY as the standard of care for Demodex blepharitis,” said Bobak Azamian, M.D., Ph.D., Chief Executive Officer and Chairman of Tarsus. “We now believe its peak potential is even greater than we initially expected at launch. With strong ongoing commercial execution, a differentiated pipeline, and a focus on category creation, we remain confident in our ability to drive sustained growth and position ourselves for long-term leadership in eye care.”

Boehringer Ingelheim and Re-Vana Therapeutics Announce Strategic Collaboration to Develop Long-Acting Ophthalmic Therapies

License Deal, News, Re-Vana

Boehringer Ingelheim and Re-Vana Therapeutics, a US and UK based developer of ocular therapeutics and ocular drug delivery technologies, today announced a strategic collaboration and license agreement that aims to develop first-in-class extended-release therapies for eye diseases.

The terms of the agreement grant Boehringer Ingelheim target exclusivity, and provide for upfront, development, regulatory and commercial milestone payments to Re-Vana, with total potential deal value exceeding $1 billion for the initial three targets, in addition to royalty payments on net sales.

Santen Launches Ryjunea® in Germany for the Treatment of Pediatric Myopia

News, Sydnexis

Following European Commission approval on June 2, 2025, Santen Pharmaceutical Co., Ltd. (hereinafter Santen) today announced that Ryjunea® (development code: STN1012701), is now available in Germany. Germany is the first market to launch Ryjunea®, with other launches across Europe to follow.
Valuation expectations are rising. If SYD-101 succeeds in both the EU and U.S., Sydnexis could command a biotech valuation in the range of $1.5 billion to $2 billion, based on typical pre-commercial revenue multiples. Investor interest is expected to accelerate in Q4 as FDA decision timelines approach.

Pelage Pharmaceuticals Announces Positive Phase 2a Clinical Trial Results for PP405 in Regenerative Hair Loss Therapy

News, Pelage

LOS ANGELES–(BUSINESS WIRE)–Pelage Pharmaceuticals, a clinical-stage regenerative medicine company, today announced positive results from its Phase 2a clinical trial of PP405 — a topical therapy for androgenetic alopecia advancing through the FDA clinical development pathway. PP405 is designed to reactivate dormant hair follicle stem cells, offering a potential first-in-class approach for both men and women experiencing hair loss.

The Phase 2a randomized controlled trial enrolled a total of 78 men and women with androgenetic alopecia, representing a diverse range of skin phototypes and hair textures. The subjects applied PP405 or a placebo on their scalp once daily for 4 weeks and were followed out to 12 weeks. The study met its primary safety endpoint and secondary pharmacokinetic endpoint: the drug was well tolerated with no systemic absorption of PP405 detected in the blood, underscoring a robust safety profile. Exploratory endpoints assessed early signs of new hair growth.

Business News Today Article: Myopia drug breakthrough: Sydnexis’ SYD-101 approved in Europe, Ryjunea launch next

News, Sydnexis

Sydnexis, a privately held U.S. biopharmaceutical company, secured a critical regulatory victory on June 5, 2025, with the European Commission granting marketing authorization for SYD-101, its proprietary low-dose atropine eye drop.

Valuation expectations are rising. If SYD-101 succeeds in both the EU and U.S., Sydnexis could command a biotech valuation in the range of $1.5 billion to $2 billion, based on typical pre-commercial revenue multiples. Investor interest is expected to accelerate in Q4 as FDA decision timelines approach.

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.