Biotech News

Oculis Announces Agreement with FDA on a Special Protocol Assessment (SPA) for Optic Neuritis Registrational Trial

Oculis (OCS)OculisFDA / regulatory

Special Protocol Assessment (SPA) agreement with the U.S. FDA provides regulatory alignment on the registrational path for Privosegtor in optic neuritis (ON) FDA Breakthrough Therapy and EMA PRIME designations in ON underscore the significant unmet need and therapeutic potential of Privosegtor as a

Related news

OCSOculis2026-03-31 08:00 EST

Oculis Announces European Medicines Agency PRIME Designation for Privosegtor, Advancing a Potential First‑in‑Class Neuroprotective Candidate for Optic Neuritis

OCSOculis2026-04-20 08:00 EST

Oculis Announces Completion of Last Patient Visit in Phase 3 DIAMOND Program with OCS-01 Eye Drops for the Treatment of Diabetic Macular Edema

OKYOOKYO Pharma2026-07-08 11:00 EST

OKYO Pharma Reports Positive Feedback from FDA Type D Meeting and Accelerates Urcosimod into Global Phase 3 Pivotal Trial for Neuropathic Corneal Pain

OTLKOutlook2026-07-24 18:40 EST

Outlook Therapeutics Announces LYTENAVA™ FDA Approval as the First and Only FDA-Approved Ophthalmic Bevacizumab for the Treatment of Wet AMD

MGTXMeiraGTx2026-03-26 12:01 EST

MeiraGTx Announces FDA Breakthrough Therapy Designation for AAV2-hAQP1 for the Treatment of Grade 2 and Grade 3 Radiation-Induced Xerostomia (RIX) and Reports Fourth Quarter and Full Year 2025 Financial and Operational Results

MGTXMeiraGTx2026-04-16 11:10 EST

MeiraGTx Announces the Acquisition of Botaretigene Sparoparvovec (bota-vec) for the Treatment of X-linked Retinitis Pigmentosa (XLRP)

TARSTarsus Pharmaceuticals2026-08-06 11:01 EST

Tarsus Pharmaceuticals to Acquire Alkeus Pharmaceuticals and Advance Eye Care Leadership Position

TARSTarsus Pharmaceuticals2026-07-08 20:05 EST

Tarsus Advances Eye Care Leadership Strategy with Acquisition of iRenix Medical and Late-Stage Asset IRX-101

OCULOcular Therapeutix2026-06-17 12:45 EST

Ocular Therapeutix™ Investor Day to Highlight U.S. FDA Alignment on AXPAXLI™ NDA with Submission Planned for Fourth Quarter 2026

HROWHarrow, Inc.2026-08-06 11:00 EST

Harrow Acquires Global Rights to TYRVAYA®, the First and Only FDA-Approved Nasal Spray for Dry Eye Disease

Oculis

Neuro-Ophthalmology Focus Oculis is a global biopharmaceutical company developing therapies for neuro-ophthalmic and ophthalmic diseases. Its strategy is centered on late-stage programs that protect visual function or apply a precision-medicine approach to ocular inflammation. Privosegtor Neuroprotection Privosegtor is a neuroprotective...

Recent company news

Stock data

Close
12.38 USD
Market cap
742.17M USD
Exchange
NASDAQ
Sector
Biopharma
Location
United States