Wednesday, May 6, 2026
VEGF Inhibitor Implant Preserves Visual Acuity, Retinal Anatomy in Wet AMD
A sustained-release VEGF inhibitor implant outperformed standard anti-VEGF therapy for maintaining visual acuity in neovascular, or wet, age-related macular degeneration (AMD), showed a randomized trial reported here.
Among patients with good baseline visual acuity, 74.1% maintained that status at 36 weeks with the axitinib implant OTX-TKI as compared with 55.8% taking standard-dose aflibercept (Eylea). The advantage in favor of the implant persisted out to 52 weeks (65.9% vs 44.2%). Three-fourths of patients randomized to OTX-TKI required no rescue anti-VEGF therapy at 36 weeks versus 56.4% of patients randomized to aflibercept. A similar proportion of patients in both groups maintained improvements in best-corrected visual acuity (BCVA) and central subfield thickness (CST) at 36 weeks.
The results showed that upfront improvements in visual and anatomical measurements are maintained in a higher proportion of patients treated with the axitinib implant, said Patricio G. Schlottmann, MD, of the Charles Ophthalmic Center in Buenos Aires, at the Association for Research in Vision and Ophthalmology meeting.
"This is the first trial to demonstrate durability of more than 9 months," he noted. "This is unmatched durability. Anatomic stability was achieved to sustain disease control, and the treatment was very well tolerated."
Providing context for the results, Schlottmann explained that the study population had good baseline visual acuity -- a mean BCVA of 70 letters -- as compared with contemporary trials of anti-VEGF therapy for AMD. In this type of patient population, maintaining visual acuity has greater clinical significance as compared with patients who have worse baseline visual acuity.
"After two loading doses, they reached a visual acuity of 80," he said. "Let me remind you that 85 is full 20/20 vision, so these patients had very little room to keep gaining vision."
During a discussion that followed the presentation, an unidentified member of the audience asked about the 25% of patients who did not have durable maintenance of baseline visual acuity and whether specific characteristics were associated with lack of treatment effect.
"We recognized these patients early on as ones that will need to be rescued, regardless of the treatment they receive," said Schlottmann. "We don't have any biomarkers if that is what you are looking for. We have a massive amount of data, and we can look into that."
OTX-TKI is a hydrogel delivery platform consisting of a bioresorbable polymer matrix combined with the VEGF tyrosine kinase inhibitor axitinib. The oral formulation of axitinib (Inlyta) has FDA-approved indications in renal cell carcinoma. The implant is designed to achieve sustained release of the drug to maintain intraocular levels with complete bioresorption. A phase I study of the intravitreal implant showed a 90% reduction in the frequency of injections for AMD, which provided the basis for the phase III randomized SOL-1 trial comparing OTX-TKI and aflibercept 2 mg in patients with AMD and preserved visual acuity.
Eligible patients had previously untreated choroidal neovascularity associated with AMD, a BCVA of at least 54 letters (~20/80 Snellen equivalent), and a CST of 500 µm or less. All patients received two doses of aflibercept 4 weeks apart and then were reassessed for randomization, which was limited to patients who had a BCVA improvement of ≥10 letters or a BCVA of ≥84 letters plus a CST ≤350 µm.
The primary endpoint was maintenance of visual acuity at 36 weeks, defined as a <15-letter loss from baseline. Follow-up continued to 52 weeks. Patients received rescue treatment if BCVA decreased by 15 letters or more or if they developed new macular hemorrhage. Data analysis included 344 randomized patients, 328 of whom completed 52 weeks of follow-up.
Schlottmann pointed out that the study population had "excellent" visual acuity from the outset, averaging about 70 letters at enrollment and about 80 letters at randomization. CST averaged 303 µm at screening and 219-227 µm at randomization.
Significantly more patients randomized to OTX-TKI met the primary endpoint, an absolute difference of almost 20% (P=0.0006). At 52 weeks, 66% of patients in the OTX-TKI arm had maintained BCVA compared with 44% of the aflibercept group (P<0.0001). Three-fourths of patients randomized to OTX-TKI had received no rescue treatment by 36 weeks as compared with 56% of the aflibercept group (P=0.0006).
Anatomical improvement was maintained in the OTX-TKI group, averaging 219 µm at randomization and 238 µm at 36 weeks. Corresponding numbers in the control arm were 227 and 258 µm.
About 11% to 12% of patients in each arm had at least one non-ocular serious adverse event (AE), and fewer than 1% of patients in both arms combined had ocular serious AEs involving the study eye.
Disclosures
The study was supported by Ocular Therapeutix.
Schlottmann disclosed relationships with Ocular Therapeutix, Novartis, Roche/Genentech, Janssen, Ora, Nanoscope, EyeBio, 4DMT, Kodak, Oculis, AbbVie, Horizon Surgical, Adverum, RevOpsis, Merit, and Amgen.
Bio-Techne misses, sees flat Q4 organic revenue before FY27 re-acceleration
Bio-Techne misses fiscal Q3 estimates with EPS $0.53 and revenue $311.4M, sees flat Q4 organic revenue before FY27 re-acceleration
- GAAP EPS $0.32, alongside adjusted EPS $0.53 reported for fiscal Q3 2026
- Investor takeaway: Reported organic revenue -2%, but +2% excluding cell therapy and OEM timing.
- Investor takeaway: Large pharma, spatial biology, GMP proteins strong; emerging biotech weakness fully explains shortfall.
- Investor takeaway: Biggest positive was 310 bps sequential adjusted operating margin expansion to 34.2%.
- Investor takeaway: Key risk is timing and magnitude of emerging biotech recovery into fiscal 2027.
- Key results: Q3 revenue $311.4M (-2% YoY), adjusted EPS $0.53 (down $0.03 YoY).
- Guidance: Q4 organic revenue about flat; ex-cell-therapy headwind, low single-digit underlying growth expected.
- Growth drivers: Large pharma double-digit growth; COMET spatial >65%; GMP proteins ~+50% ex-two fast-track customers.
- Problem areas: Emerging biotech revenue -high single digits; core reagents -mid-single digits before timing adjustment.
- Margins: Adjusted gross margin 70.4% (down 120 bps YoY), operating margin 34.2% (down 70 bps YoY).
- Management tone: Cautious near term but clearly optimistic about mid-single-digit-plus growth potential in fiscal 2027.
- Main concern: Prolonged softness and unpredictable inflection timing in emerging biotech spending despite strong recent funding.
- Mixed quarter, driven by strong pharma and high-growth platforms offset by weaker emerging biotech demand.
- Company declared a cash dividend in conjunction with its fiscal Q3 2026 results
China Wants Iran War End, Urges 'Immediate' Hormuz Reopen at Araghchi Visit Pre Trump-Xi Summit
Iranian foreign minister Abbas Araghchi is currently in Beijing meeting with his Chinese counterpart, FM Wang Yi, and the timing of the visit sends a resounding message to Washington and the West. The highly anticipated Trump-Xi meeting is still scheduled for next week, expected for May 14-15, though there has been ample speculation the ongoing events of the unpredictable Iran war and Hormuz Strait crisis could derail the trip at the last minute.
Of course, Iran and the question of peace will be high on the agenda as Trump visits - and currently it seems the White House is desperate to set in place some kind of final offramp, given the Tuesday night 'pause' in Project Freedom operations in the Gulf.
Upon the occasion of Araghchi's visit, Foreign Minister Wang has taken the opportunity to again call for the immediate opening of the strait. And the Iranian top diplomat seconded this at a moment the US Navy has imposed an effective blockade of Iranian ports, which of course severely impacts Iranian oil going to China. "Currently, it is possible to resolve the issue of reopening the Strait of Hormuz as soon as possible," Xinhua quoted Araghchi as saying.
Wang during the meeting also called for a "comprehensive ceasefire," saying his country is deeply distressed by the war. Xinhua further quoted him as saying:
"The international community shares a common concern for restoring normal and safe passage through the Strait, and China hopes the relevant parties will respond as quickly as possible to the strong calls from the international community."
The two sides are clearly coordinating their messaging to some degree, given Wang also expressed that China "appreciates Iran’s pledge to not develop nuclear weapons."
Tehran has for years insisted its program is only for peaceful nuclear energy development and for domestic needs, but has amid Trump's Operation Epic Fury made clear it will never given up its right to enriched uranium. It has said this is as "sacred as the soil" and sees it as a matter of national sovereignty. This in the face of US demands that it transfer all nuclear material out of the country.
More out of Beijing on Wednesday:
“We believe that a comprehensive ceasefire brooks no delay, a resumption of hostilities is inadvisable, and persisting with negotiations is particularly important,” Wang told Araghchi at the start of their meeting, according to footage released by Hong Kong-based Phoenix TV.
...Earlier, US Secretary of State Marco Rubio urged China to press Iran to ease its blockade of the Strait of Hormuz, through which roughly one-fifth of the world’s oil and gas passes.
As for what China gains in this high-level diplomacy and engagement with Tehran at a moment it could face more US and Israeli bombs, Associated Press presents the following:
Some noted that the Iranian foreign minister visited at Beijing’s initiative. "It’s China exercising their leverage... to summon the Iranian foreign minister," said Hoo Tiang Boon, a professor of Chinese foreign policy at Nanyang Technological University.
"By holding the talks with the Iranians, you can't fault for them not putting in any effort," Hoo said.
As for some further specifics to come out of the Araghchi-Wang meeting, Iran "expressed appreciation for China’s four-point proposal" - according to a readout in semi-official Iranian Students' News Agency (ISNA).
"Iran supports the formation of a new framework for the post-war period in the region" the readout adds. As for the 'four points' - these were issued by Beijing earlier in the conflict and are quite broad. These official points are featured below in their entirety, via Chinese state sources:
- Stay committed to the principle of peaceful coexistence. The Gulf states in the Middle East are close neighbours that cannot move away. It’s important to support the Gulf states in improving their ties, work to build a common, comprehensive, cooperative and sustainable security architecture of the Middle East and the Gulf region, and consolidate the foundation for peaceful coexistence.
- Stay committed to the principle of national sovereignty. Sovereignty serves as a foundation for all countries, especially developing countries, to survive and thrive, and it must not be violated.
- Stay committed to the principle of international rule of law. We should safeguard the authority of international rule of law, reject selective application, and prevent the world from returning to the law of the jungle. It is important to firmly uphold the international system with the United Nations at its core, the international order based on international law, and the basic norms governing international relations underpinned by the purposes and principles of the UN Charter.
- Stay committed to a balanced approach to development and security. Security is a prerequisite for development and development serves as a safeguard of security.
If negotiations between the US and Iran don't proceed, and if they stay at 'square one', this could weaken any big leverage President Trump hopes to have entering his meeting with Xi Jinping. This is perhaps why American officials are scrambling to cobble something together, to at least cite progress toward resolving the Hormuz situation. Still Trump has insisted he has "all the cards" when it comes to Iran.
Ernexa ERNA-101 plus PD-1 achieved complete tumor clearance in ovarian cancer
Ernexa Therapeutics reports ERNA-101 plus PD-1 achieved complete tumor clearance, 100% long-term survival in ovarian cancer models
- Company says ERNA-101 is advancing toward a first-in-human clinical trial following the new preclinical results
MannKind developing ralinepag dry powder inhalation (MNKD-1501) for United Therapeutics
MannKind developing ralinepag dry powder inhalation (MNKD-1501) for United Therapeutics, receives $5M payment, eligible for up to $35M milestones plus 10% royalties
- Earnings scheduled today after market close; analysts expect non-GAAP EPS $0.00 and revenue $105.4M.
BioNTech winds down COVID jab manufacturing
BioNTech has said it will halt COVID-19 vaccine manufacturing, targeting annual savings of around €500 million, and hand responsibility for producing the shots to its partner Pfizer.
The announcement came in the German biotech's first-quarter update, in which it revealed plans to close manufacturing facilities in Germany and Singapore with the loss of around 1,860 jobs – around 22% of its total workforce of 8,400.
The closed sites include some that came with its $1.25 billion takeover of CureVac last year, and BioNTech has said it hopes to complete the wind-down in the first quarter of 2027. It is also considering the "partial or total sale" of the facilities, if buyers can be found.
Germany's IGBCE union, the third-largest in the country, has criticised the job cuts, decrying them as an act of "social irresponsibility." A spokesperson for the union said: "For short-term financial reasons, they are radically reducing production capacity, thereby damaging the resilience of Germany as a pharmaceutical and biotech hub."
The IGBCE is incensed that the reductions come after years of financial aid from the German government and have been announced alongside a "multi-billion-euro share buyback programme […] that must seem like a mockery to the employees."
The revelation comes a few weeks after BioNTech's co-founders – Uğur Şahin and Özlem Türeci – announced they would be stepping down at the end of the year in order to set up a new company focused on mRNA technologies.
BioNTech has faced a massive falloff in sales of its COVID-19 vaccines since the end of the pandemic, recording €118 million ($139 million) in revenues in the first three months of this year, and has retained its guidance of €2bn to €2.3bn in full-year 2026 sales.
The company is now focusing its efforts on cancer therapies – it is retaining some manufacturing capacity for these at its Mainz headquarters, as well as in China from its acquisition of Biotheus in 2024 – and said in its update that it has started a raft of new phase 3 trials of lead candidate pumitamig, a PD-L1xVEGF bispecific antibody, in collaboration with partner Bristol Myers Squibb.
BioNTech is targeting first regulatory filings for pumitamig this year, along with six late-stage trial readouts expected across immunomodulator, antibody-drug conjugate, and mRNA cancer immunotherapies.
"We will continue to focus on accelerating our key strategic programmes as we remain steadfast in our vision to translate our science into survival for patients living with cancer," said Şahin.
https://pharmaphorum.com/news/biontech-winds-down-covid-jab-manufacturing-shedding-staff
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