- category:Pipeline
Pipeline
FDA OKs Palatin's phase 3 DED trials on melanocortin agonist
Patient enrollment for MELODY-2 and MELODY-3 studies is expected to start Q4 2024.
Pipeline
Ciliatech reports positive 36-month follow-up on glaucoma surgical implant
Results from SAFARI 1 and 2 studies demonstrate an IOP control of 8.0 mmHg and 70% reduction in medication dependence.
Pipeline
Ocuphire doses first patient in phase 3 presbyopia study on phentolamine solution
Already FDA approved as RYZUMVI for reversal of mydriasis, VEGA-3 topline data on POS 0.75% is expected by early 2025.
Pipeline
FDA grants IND clearance for BlueRock's primary photoreceptor disease cell therapy
New status paves the way for a phase 1/2a trial to evaluate the safety and efficacy of an induced pluripotent cell-derived candidate.
Pipeline
FDA grants Opus Genetics Rare Pediatric Disease Designation for LCA gene therapy
Designation qualifies OPGx-LCA5 to receive a priority review voucher, if approved.
Pipeline
Eclipse Life Sciences launches phase 2 trial on DME steroid implant
Intravitreally-injected implant is being evaluated as a 6-month, extended release therapeutic option.
Pipeline
FDA grants Atsena Rare Pediatric Disease designation for XLRS gene therapy
New designation of subretinal-injection therapeutic comes amidst the ongoing patient enrollment and dosing of the phase 1/2 LIGHTHOUSE study.
Pipeline
Lenz Therapeutics submits NDA for presbyopia eye drop
FDA has 60 days to review LNZ100 (1.75% aceclidine) as a pupil-selective and long-lasting therapeutic option.
Pipeline
Lupin reports positive phase 3 program for Lucentis biosimilar
Global clinical data on LUBT010 determined clinical equivalence between the two, supporting an eventual regulatory submission for FDA approval.
Pipeline
Eyenovia and Formosa to co-develop clobetasol propionate solution for DED
Partnership will feature FDA-approved eye drop and Optejet delivery system for precision dosing.
Pipeline
FDA OKs Ocugen's RP expanded access program in adult patients
EAP enables RP patients with at least minimal retinal preservation to benefit from OCU400 ahead of an expected 2026 BLA submission.
Pipeline
Annexon releases phase 2 and 3 clinical developments for GA therapeutic
New findings from ARCHER and ARCHER II trials support the potential for ANX007 to be the first therapeutic approved for vision protection.
Pipeline
Aldeyra reports positive phase 3 data on reproxalap for DED
Dry eye chamber trial meets primary endpoint in hopes of supporting an FDA NDA resubmission by the end of 2024.
Pipeline
First patients enrolled in Ocular Therapeutix phase 3 wet AMD study
New SOL-R trial intends to provide real-world evidence supporting the potential for axitinib intravitreal implant redosing every 6 months.
Pipeline
Adverum receives FDA RMAT designation for wet AMD gene therapy
Ixoberogene-soroparvovec is being clinically evaluated as a durable, well-tolerated, and cost-effective, in-office treatment option with extended efficacy following a single injection.
Pipeline
Eyenovia and SGN Nanopharma partner on nanoparticle-based cyclosporine for dry eye
Collaboration will integrate the Optejet topical dispenser with a unique cyclosporine formulation for a more effective treatment.
Pipeline
Viridian completes patient enrollment for THRIVE-2 chronic TED trial
Second phase 3 trial in the IGF-IR pipeline is evaluating VRDN-001, previously reported to reduce disease signs and symptoms after just two infusion sessions.
Pipeline
Refractive tech startup TECLens gets J&J investment
Private medical device company’s corneal cross-linking technology operates as a non-invasive, in-office treatment for keratoconus and progressive pediatric myopia.
Pipeline
Eyenovia and Senju to develop chronic dry eye drop-device combo
Collaboration features the Optejet dosing delivery system delivering a corneal epithelial wound healing-ophthalmic solution.
Pipeline