Wednesday, December 20, 2023
Quick Notes: December 20, 2023
FDA approves Glaukos’ iDoseTR for glaucoma; Carl Zeiss Meditec to acquire D.O.R.C.; and more.
Wednesday, December 20, 2023
FDA approves Glaukos’ iDoseTR for glaucoma; Carl Zeiss Meditec to acquire D.O.R.C.; and more.
Wednesday, December 13, 2023
FDA clears glaucoma laser device; positive data for MGD treatment in patients with Demodex mites; and more.
Wednesday, December 6, 2023
Positive data reported for wet AMD treatment; study suggest signs of glaucoma may be detectable years in advance; and more.
Wednesday, November 29, 2023
Ocutrx introduces AR/XR headset; Compulink announces advancements; and more.
Wednesday, November 22, 2023
Genentech, NVIDIA enter AI research collaboration; Ocutrx introduces OcuLenz AR/XR headset for patients with AMD; and more.
Wednesday, November 15, 2023
World’s first whole-eye, partial-face transplant performed; Bausch + Lomb receives CPT Category 1 code for XIPERE; and more.
Wednesday, November 8, 2023
Topcon launches TEMPO Perimeter for glaucoma; Lumenis introduces OptiPLUS for DED; and more.
Wednesday, November 1, 2023
FDA approves Vabysmo for the treatment of RVO; Bausch + Lomb launches SeeNa optical biometry and topography system; and more.
Wednesday, October 25, 2023
Bausch + Lomb introduces surgical planning software; Harrow completes transfer of NDAs, launches five products; and more.
Wednesday, October 18, 2023
FDA approves QLOSI for the treatment of presbyopia; Bausch + Lomb launches enVista Aspire IOLs; and more
Wednesday, October 11, 2023
Genentech announces positive long-term Vabysmo data; Alphaeon, iOR Partners form strategic alliance; and more.
Wednesday, October 4, 2023
OCULUS partners with LUVO to offer new IPL/RF devices to US ophthalmic market; Neurolens introduces new immersive, VR-based device that measures eye misalignment; and more.
Wednesday, September 27, 2023
FDA approves drops for pharmacology-induced mydriasis; CMS assigns J-code for geographic atrophy treatment; and more.
Wednesday, September 20, 2023
NeoLight’s ICON GO receives FDA clearance; Altris IMS platform granted FDA clearance; and more.
Wednesday, September 13, 2023
Bausch + Lomb announces US commercial launch of MIEBO for DED; Novartis discontinues the development of its GA gene therapy candidate GT005; and more.
Friday, September 1, 2023
FDA does not approve Outlook Therapeutics' BLA for ONS-5010 (Lytenava) for wet AMD; Prevent Blindness declares September Sports Eye Safety Month; and more.
Friday, August 25, 2023
The FDA approves Regeneron's EYLEA HD (aflibercept) Injection 8 mg for the treatment of wet AMD, DME and DR; Tarsus' XDEMVY (lotilaner ophthalmic solution) 0.25% is now available at pharmacies nationwide for prescription; and more.
Friday, August 18, 2023
Eyenovia acquires US commercial rights to APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%) from Formosa; Lupin receives approval from FDA for Bromfenac ophthalmic solution, 0.09%; and more.
Friday, August 11, 2023
FDA approves Iveric Bio’s IZERVAY for geographic atrophy; Oculis reports positive Phase 3 data for OCS-01 eyedrops; and more.
Friday, August 4, 2023
RetinalGeniX granted patent for home monitoring device; Harrow launches VIGAMOX in the United States; and more.
Friday, July 28, 2023
FDA approves Tarsus' XDEMVY (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis; Opthea announces 'sozinibercept' as the nonproprietary drug name for OPT-302; and more.
Friday, July 21, 2023
FDA grants DORC's Orphan Drug Designation application for Trypan Blue and Brilliant Blue G; Glaukos enters into collaboration and marketing agreement with Radius XR; and more.
Friday, July 14, 2023
RVL Pharmaceuticals launches ELEVATE, a prescription e-commerce platform; Bausch + Lomb announces an affiliate has purchased the Blink product line of eye and contact lens drops from Johnson & Johnson Vision; and more.
Friday, June 30, 2023
Bausch + Lomb to Acquire Novartis' XIIDRA; FDA Does Not Approve Regeneron's Aflibercept 8 mg; and more.
Friday, June 23, 2023
FDA clears Eyenuk to use Topcon NW400 retinal camera with EyeArt AI system to detect DR; FDA denies Aldeyra's NDA for ADX-2191 for PVRL; and more.
Friday, June 16, 2023
Aldeyra Therapeutics reports positive topline results from Phase 3 INVIGORATE-2 trial of reproxalap in allergic conjunctivitis; AMA adopts policy for more oversight of AI in prior authorization; and more.
Friday, June 9, 2023
FDA approves Novaliq's VEVYE for DED; FDA Clears CorNeat EverPatch non-degradable, synthetic tissue substitute; and more.
Friday, June 2, 2023
Optos Plc announces new ultra-widefield color image modality, providing additional retinal visualization; Thea Pharma announces the launch of the Preservative Freedom Coalition; and more.
Friday, May 26, 2023
Sight Sciences releases 2-year study results that show sustained reductions in IOP and glaucoma medication use in mild-moderate POAG patients treated with a procedure with the OMNI Surgical System; Oculis reports positive topline results from DIAMOND Stage 1 Phase 3 Trial in diabetic macular edema with OCS-01 eyedrops; and more.
Friday, May 19, 2023
Bausch + Lomb and Novaliq announce FDA approval of MIEBO for the treatment of the signs and symptoms of DED; Alimera Sciences acquires US commercial rights to YUTIQ for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye; and more.
Friday, May 12, 2023
Eyenovia announces FDA approval of Mydcombi ophthalmic spray for mydriasis; C. Light Technologies receives 510(k) clearance from the FDA for Retitrack retinal eye-movement monitor; and more.
Friday, May 5, 2023
Alcon announces NGENUITY 1.5 Digital 3D Visualization System is now available; Centricity Vision receives 510(k) clearance from the FDA for the new ZEPTOLink IOL Positioning System; and more.
Friday, April 28, 2023
Johnson & Johnson Vision’s ELITA Femtosecond Laser receives FDA 510(k) clearance for the creation of LASIK flaps; the FDA approves the ZEISS CT LUCIA 621P Monofocal IOL; and more.
Friday, April 21, 2023
Iridex Corp. announces full US market launch of the next-generation Iridex PASCAL laser with MicroPulse; Visus Therapeutics reports positive topline clinical data from its Phase 3 pivotal BRIO-I trial of BRIMOCHOL PF eyedrop for the treatment of presbyopia; and more.
Friday, April 14, 2023
Nova Eye Medical granted FDA 510(k) clearance for iTrack Advance canaloplasty device; Bausch + Lomb and Heidelberg Engineering introduce SeeLuma Fully Digital Surgical Visualization Platform; and more.
Friday, April 7, 2023
WaveFront Dynamics launches WaveDyn Vision Analyzer; CMS announces lower-than-expected 1.1% average cut of 2024 reimbursement rates for health insurers; and more.
Friday, March 31, 2023
Allergan, an AbbVie company, announces the FDA approved a twice-daily dosing option of VUITY in adults with presbyopia; FDA grants Breakthrough Device Designation to Pixium Vision's Prima System for dry AMD; and more.
Friday, March 24, 2023
Bausch + Lomb and Novaliq GmbH publishes second pivotal Phase 3 data on NOV03; CDC reports more cases of vision loss and death due to the extensively drug-resistant strain of Pseudomonas aeruginosa found in some artificial tears; and more.
Friday, March 17, 2023
CMS approves transitional pass-through reimbursement status for Harrow's IHEEZO; FDA clears Cognition's IND to study CT1812 for geographic atrophy in AMD; and more.
Friday, March 10, 2023
Sight Sciences announces US launch of the Ergo-Series of the OMNI Surgical System; Apotex Corp. and Pharmedica USA both issue voluntary recalls; and more.
Friday, March 3, 2023
Glaukos submits NDA to FDA for iDose TR; FDA accepts for Priority Review NDA from Aldeyra Therapeutics for ADX-2191; and more.
Friday, February 24, 2023
Apellis announces FDA approval of SYFOVRE (pegcetacoplan injection) for treatment of geographic atrophy secondary to AMD; FDA gives Priority Review status to Regeneron's BLA for aflibercept 8 mg for treatment of wet AMD, diabetic macular edema and diabetic retinopathy; and more.
Friday, February 17, 2023
Iveric bio announces FDA acceptance of NDA and grants Priority Review for avacincaptad pegol for geographic atrophy; Ocuphire announces FDA acceptance of NDA for Nyxol eyedrops for reversal of mydriasis; and more.
Friday, February 10, 2023
Phase 3 studies show Genentech’s Vabysmo rapidly improved vision and reduced retinal fluid in people with retinal vein occlusion; CDC recommends patients and health-care providers immediately discontinue using EzriCare artificial tears; and more.
Friday, February 3, 2023
Bausch + Lomb and Modulight announce FDA approval of ML6710i photodynamic laser for use with Bausch + Lomb’s VISUDYNE; FDA clears HuidaGene’s IND application for multi-national clinical trial for RPE65 mutation-associated inherited retinal dystrophies; and more.
Friday, January 27, 2023
Focus Vitamins launches Focus PI post-injection eyedrops; Ocuphire Pharma announces topline efficacy and safety results from its ZETA-1 Phase 2 trial evaluating oral APX3330 for the treatment of diabetic retinopathy; and more.
Friday, January 20, 2023
Bausch + Lomb Acquires AcuFocus Inc.; Horizon Therapeutics' Phase 2 trial evaluating dazodalibep for Sjögren’s Syndrome meets primary endpoint in second study population; and more.
Friday, January 13, 2023
Ocuphire announces initiation of VEGA-2 Phase 3 pivotal trial to evaluate Nyxol for presbyopia; Bausch + Lomb introduces enhanced PreserVision AREDS 2 Formula mini soft gels with OCUSorb; and more.
Friday, January 6, 2023
Orasis submits an NDA to the FDA for investigational CSF-1, a novel corrective eyedrop candidate for presbyopia; Kala announces the FDA accepted an IND application for KPI-012 for persistent corneal epithelial defect; and more.