FDA Accepts NDA for Orasis' CSF-1
• Orasis Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) accepted for review its New Drug Application (NDA) for investigational CSF-1 (low dose pilocarpine hydrochloride 0.4%), and assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 22, 2023. The NDA is based on data from two Phase 3 clinical trials (NEAR-1 and NEAR-2), which involved more than 600 patients and evaluated the efficacy and safety of CSF-1.
In a press release Orasis said both trials met their primary and key secondary endpoints on Day 8, achieving statistically significant 3-line or more gain in distance-corrected near visual acuity (DCNVA), and no loss of 1-line or more in distance visual acuity. The most common treatment-related adverse events were headache and instillation site pain, and these occurred in only 6.8% and 5.8% of participants, respectively. Only 2.6% of all CSF-1 participants in the trial reported moderate treatment-related adverse events. All other adverse events were mild.
Ocuphire Starts Enrollment in VEGA-2 Presbyopia Trial, Announces PDUFA Date for Reversal of Mydriasis Indication
• Ocuphire Pharma has begun enrolling its phase 3 study of Nyxol 0.75% phentolamine eye drop, the company announced in January. The trial, called VEGA-2, is a randomized, double-masked, placebo-controlled study to be conducted at 30 centers in 2 stages. In the first stage, Nyxol will be compared with placebo in 320 subjects; in the second stage, another 320 subjects will be randomized to receive Nyxol plus low-dose pilocarpine (LDP), Nyxol plus LDP vehicle, placebo plus LDP, and placebo plus LDP vehicle.
“In our previous phase 2 VEGA-1 trial, Nyxol alone demonstrated compelling results with rapid onset and sustained 18-hour duration of efficacy and a favorable safety profile,” said Ocuphire’s chief medical advisor Jay Pepose, MD, PhD, in a press release. “Then the LDP combination option also offers the potential for tunability of treatment based on the patient’s lifestyle and response to Nyxol alone.”
The primary endpoint of VEGA-2 will be the proportion of subjects with ≥15 letters of improvement in photopic binocular distance-corrected near visual acuity and with <5 letters of loss in photopic binocular BCDVA in Nyxol-treated subjects. Ocuphire will also launch another phase 3 presbyopia trial and a 1-year safety study later this year.
In other news, Ocuphire has announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Nyxol for the treatment of pharmacologically-induced mydriasis. The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of September 28, 2023.
Eyenovia Announces Development Collaboration with Formosa Pharmaceuticals
• Eyenovia has entered into a development collaboration agreement with Taiwan-based Formosa Pharmaceuticals. A press release says the agreement “seeks to combine Eyenovia’s Optejet dispensing technology with Formosa’s unique APNT nanoparticle formulation platform for the potential development of new topical ophthalmic therapeutics that employ the Optejet dispenser.”
The release further explains that Formosa’s proprietary APNT platform reduces an active pharmaceutical ingredient’s particle size with high uniformity and purity, allowing penetration to the eye, and enhancing bioavailability.
The companies intend to collaborate on testing formulations and engaging in discussions with the Food and Drug Administration (FDA), with the goal of executing a Development and Commercialization Agreement under which the companies would work to develop new drugs leveraging APNT formulations in the Optejet dispenser.
New C-Suite Faces at Ace Vision Group
• Ace Vision Group (AVG) announced in January its appointment of new leadership for its business development and commercial teams. John Frantzis, the new chief business development officer, comes to Ace from Heru, a company spun off from the Bascom Palmer Eye Institute that makes a wearable visual fields testing device, and he has experience on the management teams of Summit Technology and Avedro. The new chief commercial officer Alex Lopez was most recently CCO at Legrande Health, in addition to experience in ophthalmic therapeutics at Alcon.
The two new hires are expected to play key roles in the rollout of Ace’s VisioLite Ophthalmic Laser System, which helps treat presbyopia by laser scleral microporation (LSM) – a laser process that overcomes ocular rigidity to allow for recovery of dynamic range of focus (DRoF). “Building an impeccable executive leadership of C-level talent will contribute immeasurably to AVG’s continual growth toward commercialization of our flagship technology, the VisioLite Ophthalmic Laser System and the LSM procedure,” said Ace founder and CEO AnnMarie Hipsley, DPT, PhD, in a press release.
More recently, AVG announced the appointment of Cristos Ifantides, MD, MBA, as director, clinical applications development, who will lead education and clinical adoption efforts of AVG's presbyopia technology platform.
B+L and AcuFocus Merge Following First Apthera Implantations
• Bausch + Lomb announced January 17 that it has acquired AcuFocus, a privately held company, via one of its subsidiaries in preparation for an eventual merger with AcuFocus’ parent company. “We believe that the IC-8 Apthera enhanced depth of focus (EDOF) IOL will bolster our surgical portfolio by enhancing our IOL offerings, which is a strategic area of focus for Bausch + Lomb,” said Joseph C. Papa, CEO of Bausch + Lomb, in a press release.
This merger news comes less than 2 weeks after AcuFocus announced the first implantations of its Apthera IOL, which is the only small-aperture nontoric EDOF IOL for cataract patients with corneal astigmatism as much as 1.5D and who also want their presbyopia treated.
The implantations were performed by Vance Thompson, MD, at his private practice in Sioux Falls, SD, who said, "This unique lens mitigates presbyopia’s effects in an elegantly simple way—by filtering out peripheral defocused and aberrated light that degrades image quality to allow only central focused light to be delivered to the retina.” ■