• The iDose TR from Glaukos Corp. is now commercially available. The iDose TR uses VitalDose EVA from Celanese Corp. to provide sustained drug release for the treatment of glaucoma. iDose TR, which received FDA approval in Dec. 2023, is a long-duration, intracameral procedural pharmaceutical therapy designed to continuously deliver 24/7 therapeutic levels of a proprietary formulation of travoprost inside the eye for extended periods of time. The VitalDose EVA creates a nanoporous membrane for travoprost delivery in iDose TR, and it can be formulated into a wide range of form factors to suit drug delivery needs for various conditions. 

• CorNeat Vision introduced the CorNeat EverPatch synthetic tissue substitute for ocular surface surgeries. Its novel structure enables seamless integration with surrounding tissue without triggering a chronic foreign body response, and its non-degradability permanently reinforces the ocular surface. The CorNeat EverPatch provides a solution for reinforcing tissue over glaucoma drainage devices, addressing complications such as tube exposure that often require reoperation, the company says. At 100 microns thick, the device is a thinner alternative to tissue grafts, allowing it to conform better to the eye wall.

• Formosa Pharmaceuticals and AimMax Therapeutics announced the FDA approved clobetasol propionate ophthalmic suspension 0.05% (APP13007) for the treatment of post-operative inflammation and pain following ocular surgery. Utilizing a super potent corticosteroid, clobetasol propionate ophthalmic suspension 0.05% is derived from Formosa Pharma's proprietary APNT nanoparticle formulation platform. This formulation offers patients a convenient dosing regimen (twice daily for 14 days without tapering). Two Phase 3 clinical trials demonstrated rapid and sustained clearance of inflammation and pain relief that was statistically and clinically superior to its matching placebo (p<0.001). 

• Palatin Technologies announced the results for its PL9643 MELODY-1 pivotal Phase 3 clinical trial evaluating the safety and efficacy of PL9643 vs vehicle in the treatment of dry eye disease. After adjusting the Intent-to-Treat (ITT) analysis for age and gender, PL9643 treatment demonstrated clinically meaningful (visual analog score reduction of >10 points from baseline) and statistically significant results for the co-primary symptom endpoint of pain (p<0.025) and multiple other symptom endpoints. PL9643 treatment for the co-primary sign endpoint and secondary sign endpoints demonstrated positive treatment effects over vehicle in the ITT population but did not achieve statistical significance. In the unadjusted planned analyses, the co-primary endpoints and secondary endpoints did not reach statistical significance. Safety analysis indicated PL9643 was well-tolerated. For more, see the study results here.

• PulseSight Therapeutics SAS, with seed finance from Pureos Bioventures and ND Capital, launched to advance non-viral gene therapies with minimally-invasive delivery technology for severe retinal diseases. The company says it is poised to clinically validate its delivery platform by advancing two first-in-class late-stage preclinical drugs for wet and dry AMD, including geographic atrophy. PulseSight’s proprietary non-viral gene therapy ocular platform uses an electro-transfection system to deliver DNA plasmids encoding therapeutic proteins into the ciliary muscle to treat major eye diseases. The technology has already been validated in a first Phase 1/2 clinical study, demonstrating a good safety profile of both the plasmid and the delivery system, as well as a long-lasting clinical benefit up to 8 months (in patients with chronic noninfectious uveitis).

• Coherus BioSciences announced the completion of the previously announced divestiture of its CIMERLI (ranibizumab-eqrn) ophthalmology franchise through the sale of its subsidiary, Coherus Ophthalmology LLC, to Sandoz Inc. for upfront all-cash consideration of $170 million. This divestiture included Coherus’ CIMERLI biologics license application, ophthalmology sales and select field reimbursement teams, and access to proprietary commercial software. Coherus received upfront, all-cash consideration of $170 million plus certain purchase price adjustments, which will be finalized following the closing pursuant to the agreement between Coherus and Sandoz.

• Amring Pharmaceuticals announced its name change to Nordic Pharma, following the change in ownership of the company from SEVER Life Sciences, B.V. to Nordic Group, B.V., a subsidiary of SEVER Life Sciences B.V. The change in the corporate name provides for better alignment strategically with the parent company headquartered in the Netherlands and its subsidiaries worldwide. Together, the companies look to expand the global footprint in eye care, rheumatology, woman’s health, and critical care for branded products as well as strengthening their generic product business in the United States. As part of this growth strategy, Nordic Pharma recently acquired Visant Medical. The acquisition included the FDA cleared hyaluronic acid derivative LACRIFILL canalicular gel, which is intended to temporarily block tear drainage by the occlusion of the canalicular system. Nordic Pharma will launch LACRIFILL in the United States in Q2 2024 followed by a global rollout.

Quick Notes is published weekly. Unless otherwise noted, the information presented is based on press releases. Find earlier editions here. To submit a press release to be considered for publication, click here.