Ophthalmic pharmaceutical and medical technology company developing products for glaucoma, corneal disease and retinal disease, spanning minimally invasive implants (iStent) and drug therapies (iDose TR). Note: its device and pharmaceutical businesses carry comparable weight; this is not a pure pharmaceutical company.
Clinical Trials
69
5 active
Approvals
4
Total approvals
Agencies
1
Regulatory bodies
Founded
1998
Active, not recruiting
5
7.3%
Completed
39
56.5%
Recruiting
13
18.8%
Terminated
6
8.7%
Unknown
5
7.3%
Withdrawn
1
1.4%
- China's National Medical Products Administration accepted for review the NCX 470 New Drug Application submitted in August 2026 by licensee Ocumension Therapeutics. - NCX 470 is a nitric oxide-donating bimatoprost eye drop that lowers intraocular pressure through two distinct pathways in open-angle glaucoma or ocular hypertension. - The Chinese review is expected to take 12 to 18 months, with a decision anticipated after the U.S. FDA's 30 April 2027 PDUFA date. - Ocumension has paid Nicox EUR 18 million in license fees, funded 50% of the Denali trial, and will pay tiered royalties of 6% to 12% on sales.
- Glaukos Corporation has commercially launched Epioxa, the first and only FDA-approved epithelium-on corneal cross-linking therapy for keratoconus treatment in the United States. - The oxygen-enriched topical treatment offers a minimally invasive, incision-free alternative to traditional cross-linking procedures, reducing treatment duration, complexity, and pain while shortening recovery time. - The launch includes comprehensive patient access support through EpioxaCareConnect program, featuring benefits investigation, copay assistance, and specialty pharmacy services. - Glaukos announced substantial investments in patient awareness and education initiatives to address underdiagnosis and undertreatment of keratoconus.
- iVeena Delivery Systems has dosed the first participant in its Phase 1, first-in-human clinical study of IVMED-85, a novel eye drop designed to prevent myopic progression. - The randomized, controlled trial is evaluating the safety and tolerability of twice daily dosing of IVMED-85 in healthy adult volunteers, with dosing completion expected in Q2 2026. - IVMED-85 is a preservative-free, non-atropine eye drop that strengthens scleral and corneal collagen crosslinks through LOX activation to potentially reduce axial elongation. - The Phase 1 results will inform future pediatric studies, with a Phase 2 trial planned for the second half of 2026.
- Bausch + Lomb has entered into an evaluation program and licensing option agreement with Ripple Therapeutics to develop sustained-release implants for ophthalmic diseases using polymer-free technology. - Ripple's proprietary Epidel platform chemically engineers drugs into prodrugs that form implants without polymers, enabling zero-order release kinetics through surface erosion and leaving no residue after drug release. - The collaboration follows Ripple's recent partnerships with AbbVie for glaucoma treatment and Glaukos Corporation for both glaucoma and retinal disease applications. - Bausch + Lomb will fund early-stage feasibility and preclinical evaluation of a target molecule while holding licensing options for successful formulations.
- Glaukos Corporation secured FDA approval for Epioxa, a breakthrough treatment for keratoconus, a rare and progressively debilitating eye condition. - The company's stock surged 13.49% following the approval, with Wells Fargo upgrading its price target from $92 to $120 based on Epioxa's growth potential. - Glaukos exceeded Q3 2025 financial expectations with increased sales and improved margins, projecting revenue between $600M-$620M for fiscal year 2026. - The FDA approval positions Glaukos as a leader in corneal therapy within a specialized niche market with limited competition.
- Glaukos Corporation announced FDA approval of Epioxa HD/Epioxa, the first FDA-approved incision-free topical drug therapy for keratoconus that eliminates the need for corneal epithelium removal. - The approval is based on two Phase 3 pivotal trials involving over 400 patients that successfully achieved primary efficacy endpoints with favorable safety profiles. - Epioxa represents a transformative advancement in keratoconus care, designed to eliminate pain associated with traditional procedures while streamlining treatment and minimizing recovery time. - Commercial availability is expected in Q1 2026, with Glaukos planning substantial investments in patient awareness and access programs to address underdiagnosis and undertreatment challenges.
- Glaukos Corporation, a leader in ophthalmic pharmaceuticals and medical technologies, broke ground on an $82 million, 200,000-square-foot research, development, and manufacturing facility in Huntsville's Cummings Research Park. - The facility will focus on developing novel therapies for glaucoma, corneal disorders, and retinal diseases, with plans to initially employ more than 150 people at an average wage of $34.66 per hour. - The company evaluated over 100 potential sites worldwide before selecting Huntsville, citing the area's strong talent base, scientific pedigree, and status as the second largest research park in the country. - Construction is expected to be completed by 2030, with potential for future expansion to 400,000 square feet on an additional 15 acres, representing a total investment that could reach $100 million.
- iVeena Delivery Systems received a $2 million Phase 2 SBIR grant from the National Eye Institute to develop IVMED-85, a novel topical eye drop for pediatric myopia. - The preservative-free therapy works through a unique mechanism that enhances corneal and scleral crosslinking while avoiding side effects of current off-label treatments. - With over 20 million affected children in the US and no FDA-approved therapies available, this represents a significant unmet medical need. - The company submitted an IND application to the FDA in June 2025 and plans to initiate a multinational Phase 2 study.
- Major pharmaceutical companies including AbbVie, AstraZeneca, and Merck are actively developing controlled drug release systems to enhance treatment of chronic diseases, cancer, and neurological disorders. - The market is shifting toward personalized and targeted drug delivery mechanisms driven by biotechnology advances and precision medicine approaches. - Non-invasive delivery methods such as implantable systems and transdermal patches are gaining traction for improved patient convenience and compliance. - Clinical trials span multiple therapeutic areas from pain management and oncology to neurological diseases and metabolic disorders, validating safety and efficacy of these advanced delivery systems.
- iVeena Delivery Systems has submitted an Investigational New Drug application to the FDA for IVMED-85, a first-in-class eye drop targeting pediatric myopia through lysyl oxidase activation. - The preservative-free daily eye drop represents a non-atropine approach that strengthens scleral and corneal collagen crosslinks to potentially reduce myopic progression. - With myopia affecting approximately 40% of children in the US, IVMED-85 addresses a critical unmet medical need in pediatric ophthalmology. - The company plans to initiate a multinational Phase 2 clinical trial in 2025 pending FDA approval within the expected 30-day review period.
